Dans une étude devant être présentée le 14 février entre 8 et 10 heures, au 33^e congrès annuel de la Society for Maternal-Fetal Medicine, The Pregnancy Meeting™, les chercheurs présenteront des résultats suggérant que le 17P, une forme de progestérone, n’est pas efficace pour prévenir l’accouchement prématuré chez les femmes enceintes de jumeaux, et il pourrait même être nocif.

Bien que le 17P (caproate de 17 alpha-hydroxyprogestérone) se soit avéré prévenir l’accouchement prématuré chez environ le tiers des femmes avec grossesse monofœtale qui ont fait l’expérience d’un accouchement prématuré dans le passé, cette toute dernière recherche montre que l’administration de 17P ne produit pas les mêmes effets pour les mères ayant des jumeaux, déclarent les auteurs.

« Nous avons constaté que le 17P n’était pas efficace chez les femmes avec grossesse gémellaire et col de l’utérus court (défini comme moins de 25 mm entre 24 et 32 semaines) », déclare le docteur Philippe Deruelle attaché au sein du service de gynécologie-obstétrique de l’Hôpital Jeanne de Flandre,  Université Lille 2 (France) et l’un des auteurs de l’étude. « Il semble que nous ayons, en fait, observé un accroissement du taux d’accouchement prématuré avant 32 semaines dans le groupe de traitement par rapport au groupe non traité. ».

Aux fins de l’étude présentée dans le résumé intitulé : Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial,Deruelle et ses collaborateurs ont réalisé leur essai sur 165 femmes âgées de plus de 18 ans à 10 hôpitaux universitaires entre juin 2006 et janvier 2010. Les données de résultats étaient disponibles pour 161 des 165 (97,6 %) femmes.

« Les jumeaux sont exposés à un très grand risque de naissance prématurée ; en fait, 60 pour cent des jumeaux naissent prématurément. Nous ne pouvons présumer que les traitements efficaces pour les grossesses monofœtales le sont aussi pour les grossesses multiples dont des grossesses de jumeaux ou de triplés », déclare le docteur Edward R. B. McCabe, PhD, vice-président principal et directeur médical de March of Dimes. « Ce résultat de recherche est précieux en ce qu’il influera sur le soin des femmes dans une grossesse multifœtale, et il souligne la nécessité de mieux comprendre la façon de prévenir l’accouchement prématuré dans le cas d’une grossesse multifœtale. »

Le docteur Deruelle recommande l’échographie chez les femmes qui savent qu’elles sont enceintes de jumeaux et ce, afin de mesurer la longueur du col de leur utérus. Il a été montré que ce facteur permet de prédire quelles femmes enceintes de jumeaux sont exposées à un risque plus élevé d’accouchement prématuré.

Le docteur McCabe décernera au docteur Deruelle le prix March of Dimes du meilleur résumé de la section Prématurité lors du congrès annuel de la SMFM. 2013 marque le dixième anniversaire de présentation du prix March of Dimes.

L’étude a été réalisée non seulement par le docteur Deruelle, mais aussi par Marie-Victoire Senat, Hôpital Bicêtre, Hôpital Antoine Béclère, APHP, Paris Sud, Faculté de Médecine Paris XI, Département d’obstétrique et de gynécologie à Clamart (France) ; Norbert Winer, Hôpital Mère-Enfant, Département d’obstétrique et de gynécologie à Nantes (France) ; et Patrick Rozenberg, Hôpital Poissy Saint-Germain, Département d’obstétrique et de gynécologie à Poissy (France).

# # #

Une copie du résumé est affichée sur le site http://www.smfmnewsroom.org/wp-content/uploads/2013/01/1-8.pdf et ci-après. Pour obtenir des entrevues, veuillez communiquer avec Vicki Bendure à Vicki@bendurepr.com, 540-687-3360 (bureau) ou 202-374-9259 (cellulaire), ou Meghan Blackburn à Meghan@bendurepr.com, 540-687-5099 (bureau) ou 859-492-6303 (cellulaire).

La Society for Maternal-Fetal Medicine (fondée en 1977) est une association à but non lucratif d’obstétriciens/gynécologues membres qui ont poursuvi des études formelles et possèdent une formation supplémentaire en médecine maternelle-fœtale. La société axe ses efforts sur la réduction des complications des grossesses à haut risque en fournissant un enseignement continu à ses 2000 membres sur les toutes dernières méthodes d’évaluation et de traitement de la grossesse. Il se fait également le promoteur de l’amélioration des politiques publiques et de l’expansion des subventions de recherche et des opportunités en médecine maternelle-fœtale. Le groupe se fait l’hôte d’un congrès scientifique annuel dans le cadre duquel de nouvelles idées et de nouveaux travaux de recherche dans le domaine de la médecine maternelle-fœtale sont dévoilés et abordés. Pour plus de renseignements, veuillez visiter www.smfm.org ou www.facebook.com/SocietyforMaternalFetalMedicine.  

En 2013, March of Dimes célébrera son 75^e anniversaire et son travail continu pour aider les bébés à partir du bon pied dans la vie. Des recherches antérieures ont mené aux vaccins contre la poliomyélite Salk et Sabin que tous les bébés continuent à recevoir. D’autres percées comprennent de nouveaux traitements pour les bébés prématurés et les enfants présentant des malformations congénitales. Environ quatre millions de bébés naissent chaque année aux États-Unis, et tous ont bénéficié des recherches et de l’enseignement de March of Dimes qui ont sauvé des vies. March of Dimes est l’association à but non lucratif de premier rang en matière de grossesse et de santé des bébés. Avec son réseau national de sections et son événement de premier rang, March for Babies®, March of Dimes s’efforce d’améliorer la santé de bébés en prévenant les malformations congénitales, l’accouchement prématuré et la mortalité infantile. Pour obtenir les toutes dernières ressources et informations, visitez le site marchofdimes.com ou nacersano.org.

Résumé 3 : Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial (Prévention de l’accouchement prématuré par caproate de 17 alpha-hydroxyprogestérone dans les grossesses gémellaires de femmes avec col de l’utérus court : essai contrôlé randomisé)

Marie- Victoire Senat 1, Philippe Deruelle 2, Norbert Winer 3, Patrick Rozenberg 4

1 Hôpital Bicêtre, Hôpital Antoine Béclère, APHP, Paris Sud, Faculté de Médecine Paris XI, Département d’obstétrique et de gynécologie, Clamart (France) ; 2 Hôpital Jeanne de Flandre, CHU Lille, F-59000, EA2694, UDSL, Université Lille Nord de France, Département d’obstétrique et de gynécologie, Lille (France) ; 3 Hôpital Mère-Enfant, Département d’obstétrique et de gynécologie, Nantes (France) ; 4 Hôpital Poissy Saint-Germain, Département d’obstétrique et de gynécologie, Poissy (France).

OBJECTIF : Évaluer l’utilisation du caproate de 17 alpha-hydroxyprogestérone (17P) afin de réduire le risque d’accouchement prématuré dans la grossesse gémellaire asymptomatique de femmes avec un col de l’utérus court.

CONCEPTION DE L’ÉTUDE : Cet essai ouvert, multicentrique, randomisé et contrôlé a été réalisé à dix hôpitaux universitaires entre juin 2006 et janvier 2010. Les femmes âgées de plus de 18 ans et enceintes de jumeaux étaient admissibles entre 24+0 et 31+6 semaines de grossesse, inclusivement, si elles étaient asymptomatiques, si le col de leur utérus était de moins de 25 mm comme mesuré par échographie transvaginale de routine et si elles fournissaient un consentement éclairé écrit. Les femmes étaient affectées au hasard dans un rapport de 1:1 à recevoir 500 mg de 17P intramusculaire, traitement répété deux fois par semaine jusqu’à 36 semaines ou l’accouchement prématuré, suivant l’événement survenant en premier, ou à l’absence de traitement par 17P (groupe témoin). L’aboutissement primaire était le temps depuis la randomisation jusqu’à l’accouchement.

RÉSULTATS : Les caractéristiques maternelles des 82 femmes du groupe 17P et des 83 femmes du groupe témoin étaient similaires. Les données de résultats étaient disponibles pour 161 des 165 femmes (97,6 %). L’analyse en intention de traiter avec censure au dernier suivi n’a montré aucune différence significative entre les groupes 17P et témoin dans le temps médian [Q1-Q3] jusqu’à l’accouchement (45 [26-62] et 51 [36-66] jours, respectivement ; la différence moyenne ­– 7 ; l’IC 95 %, – 15 ; +1). Le traitement par 17P était associé à un accroissement significatif du taux d’accouchements prématurés avant 32 semaines de grossesse (29 par rapport à 12 %, p 0,007), mais non avant 37 semaines de grossesse (80 par rapport à 77 %, p=0,70) ou 34 semaines de grossesse (44 par rapport à 28 %, p=0,10). Le poids médian [Q1-Q3] à la naissance ne différait pas entre les groupes 17P et témoin pour le jumeau 1 (2120 [1750-2471]g et 2215 [1982-2535] g, p=0,06) mais il différait sensiblement pour le jumeau 2 (2090 [1540-2425] et 2230 [1985-2535] g, p=0,027). On observait une tendance non significative à un accroissement de la morbidité néonatale au sein d’un groupe 17P.

CONCLUSION : 17P est inefficace chez les femmes avec jumeaux asymptomatiques et col de l’utérus court pour la prévention de l’accouchement prématuré et il est possiblement nocif.

This randomized study, Sex-specific genetic susceptibility to adverse neurodevelopmental outcome after early preterm birth, may improve understanding of how developmental problems occur after preterm birth and may help identify prevention strategies.

“Preterm birth is the leading cause of childhood brain injury,” said the study’s author, Erin Clark, MD. “Compared to preterm girls, preterm boys are more likely to die, and survivors are more likely to have long-term problems, including disability and cerebral palsy. We don’t understand why preterm boys are at a disadvantage compared to girls.”

Through her study, Clark, assistant professor of Maternal-Fetal Medicine at the University of Utah School of Medicine, determined whether genetic variants influence the risk of developmental problems after a preterm birth, and whether there is a difference in risk factors between males and females.

Clark evaluated patients previously enrolled in a randomized trial of magnesium sulfate before preterm birth for prevention of cerebral palsy. She evaluated children that died before their first birthday, or developed cerebral palsy or other developmental problems by age 2 years, and compared them to healthy children.

The research shows a variant in the inflammation gene, interleukin 6, was associated with developmental problems in females but not in males. Treatment with magnesium sulfate before birth didn’t appear to change this risk.

“These results add to the evidence that inflammation genes play a role in risk of brain injury in preterm children. In addition, they suggest that genetic risk factors for brain injury after early delivery may be different in boys and girls,” said Clark. “However, the effect of genes and gender on outcomes after preterm birth remains poorly understood. Additional research is necessary in order to better understand the differences in outcomes between males and females born preterm.”

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org/wp-content/uploads/2013/01/18-26.pdf and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine.

Abstract 21: Sex-specific genetic susceptibility to adverseneurodevelopmental outcome after early preterm birth

Erin A. S. Clark, Maternal Fetal Medicine Units Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md.

OBJECTIVE: In-vivo and in-vitro data suggest neurobiological differences between male and female susceptibility and response to brain injury. We aimed to determine if sex-specific genetic susceptibility loci are associated with adverse neurodevelopmental outcome after early preterm birth.

STUDY DESIGN: Secondary case-control analysis of a randomized trial of magnesium sulfate (MgSO4) before anticipated early preterm birth (<32 weeks) for prevention of cerebral palsy (CP). Cases died by age 1 year or developed CP, mental or psychomotor delay (defined as

Bayley MDI or PDI<70) by age 2. Controls were survivors with normal neurodevelopment. Neonatal DNA was evaluated for 80 polymorphisms (33 genes) in inflammation, coagulation, vasoregulation, excitotoxicity and oxidative stress pathways using Taqman assays. Cases and controls were matched by maternal race and infant sex. Conditional logistic regression determined the odds ratio for each polymorphism (additive model) by sex stratum and adjusted for gestational age at birth, maternal education level, and exposure to MgSO4 and antenatal corticosteroids. An interaction term between infant sex and genotype tested heterogeneity across strata. Holm-Bonferroni method was used to adjust for multiple comparisons (p<7.3×10-4).

RESULTS: Analysis included 211 cases (134 males and 77 females) and 215 controls (130 males and 83 females). A polymorphism in the inflammatory cytokine interleukin-6 (IL6) gene (rs2069840) was associated with adverse neurodevelopmental outcome in females (OR 2.6, 95% CI 1.5-4.7; p0.001), but not in males (OR 0.8, 95% CI 0.5-1.2; p0.33). The effect difference between males and females was significant (p7.0×10-4). MgSO4 exposure did not modify this association. The remaining gene-sex associations were not significant after correction for multiple comparisons.

CONCLUSION: An IL6 gene locus may confer sex-specific susceptibility to adverse neurodevelopmental outcome in females after early preterm birth.

This randomized study, entitled Occurrence of pregnancy complications in women with BMI >25 submitted to a healthy lifestyle and eating habits program, should help physicians understand why it is important to offer more specific advice to obese women who are pregnant regarding the amount of weight they should gain during their pregnancy.

“Weight gain should be monitored related closely to the starting weight. If you start with normal BMI [defined by weight before pregnancy divided by height measured in squared meters] could increase 11-16 kilograms. But if you are obese, the expectation is that you should only gain 5-9 kilos—more or less just the weight of the pregnancy” said Dr. Fabio Facchinetti, referencing the Institute of Medicine (IOM) in the United States.

Researchers from the University of Modena and Reggio Emilia’s mother-infant department teamed up with their colleagues in the clinical diagnostic medicine and public health department to create a Therapeutic Lifestyle Changes (TLC) Program. The 33 women in the treatment group followed a regimen of 1500 kcal/day diet coupled with mild physical activity (30 minutes/day, 3 times/week). Twenty-eight women in the control group just received general advice from their OB/GYN. They only worked with single pregnancies and treatment began at 12 weeks.

Their research shows that of the obese subgroup of women [those in TLC group with BMI>30] who stuck with a proper diet and exercise, 77.8 percent were able to stay within the allotted weight gain limit, as opposed to only 30 percent from the control group. Additionally, the rate of, hypertension, preterm delivery and gestational diabetes was significantly lower in the TLC group.

“The diagnosis of gestational diabetes is done [by having the women drink] 75 grams of glucose and looking at the levels after one and two hours,” said Facchinetti. “In our study, we found [after monitoring the glucose levels] that 57 percent of obese women in the non-treatment group had diabetes whereas in the treatment group, it was only 21 percent. This is important because [the glucose test] was done at 16-18 weeks and, even if negative, repeated at 24 weeks. In other words, if the first evaluation occurred just 12 weeks after the treatment began, the small amount of time was enough to correct the body’s level of glucose.”

The study was conducted by Fabio Facchinetti, Elisabetta Petrella, Lucrezia Pignatti and Isabella Neri of the University of Modena and Reggio Emilia, Mother-Infant Department, Modena, Italy; and Marcella Malavolti, Valentina Bertarini and Nino Carlo Battistini of the University of Modena and Reggio Emilia, Clinical Diagnostic Medicine and Public Health, Modena, Italy.

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org/wp-content/uploads/2013/01/53-61.pdf and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com, 540-687-3360 (office) or 202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine. 

Abstract 55: Occurrence of pregnancy complications in women with BMI >25 submitted to a healthy lifestyle and eating habits program

Elisabetta Petrella¹, Fabio Facchinetti¹, Marcella Malavolti², Valentina Bertarini², Lucrezia Pignatti¹, Isabella Neri¹, Nino Carlo Battistini²

¹University of Modena and Reggio Emilia, Mother-Infant Department, Modena, Italy; ²University of Modena and Reggio Emilia, Clinical Diagnostic Medicine and Public Health, Modena, Italy

OBJECTIVE: We evaluated if changing eating habits and introducing a correct lifestyle in women with BMI>25 would improve unfavorable maternal-fetal outcomes associated with excessive weight gain in pregnancy.

STUDY DESIGN: In a prospective design, women with BMI>25 at 1^st trimester were randomized to no intervention (28 cases) or a Therapeutic Lifestyle Changes (TLC) Program including diet (1500 kcal/day) and mild physical activity (30 minutes/day, 3 times/week) (33). At baseline and at 3rd trimester women filled-in a Food Frequency Questionnaire (FFQ). Patients with chronic disorders were excluded. Prenatal care was similar in both groups. Outcomes included diagnoses of GDM (75 g OGTT at 24-28 weeks) or gestational hypertension, weight gain, and Preterm Delivery. Data were stratified by BMI.

RESULTS: Socio-demographic features were similar between groups. At delivery, women of TLC group (78.9%) remained in IOM recommended weight gain ranges significantly more than controls (44%, p=0.02). The occurrence of GDM, gestational hypertension and Preterm Delivery was significantly lower in TLC group (Table). Large for gestational age babies were similar among groups. Significant changes in eating behavior occurred in TLC group which increased the habit of breakfast and the frequency of snacks. Moreover, intervention increased the rate of women avoiding sugar (from 3.9% to 43.8%) as well as the rate of those that include vegetables in every meal (from 3.9% to 37.5%).

CONCLUSION: A constant physical activity and a change toward healthy eating improves nutrients intake, prevent excessive weight gain and avoid the maternal unfavorable outcomes associated with overweight/obese women.

The study collected data from all IVF treatments in Denmark, Norway and Sweden from 1984 – 2007, then cross-linked with the Nordic Medical Birth Registries. Babies born after FER (6,653) were compared to those born after fresh IVF (42,287) and the general population (288,868). Researchers looked for eight different outcomes: low birth weight, very low birth weight, preterm birth, very preterm birth, small for gestational age, macrosomia (excessive birth weight), large for gestational age, and stillbirth.

“FER is used increasingly in IVF programs to avoid the risks associated with multiple births,” said Ulla-Britt Wennerholm, of Sahlgrenska University Hospital in Göteberg, Sweden. “We sought to analyze the outcomes compared to spontaneous conceptions and fresh IVF.”

Dr. Wennerholm and her associates found children born after FER had higher rates of PTB, very PTB, LBW, very LBW, LGA, and macrosomia compared to spontaneous conceptions. However, when compared to fresh IVF births, children born after FER fared better, having lower rates of PTB, LBW, and SGA. But they also found children born after FER to have higher rates of LGA and macrosomia than those born from fresh IVF.

Researchers concluded outcomes for FER to be better compared to fresh IVF, but worse compared to the general population. However, they believe the higher rates of LGA and macrosomia compared to fresh IVF will require further attention.

This study was conducted by Ulla-Britt Wennerholm, Sahlgrenska University, Obstetrics and Gynecology, Göteberg, Sweden; Anna-Karina Henningsen and Anja Pinborg, Rigshospitalet, Fertility Clinic, Köpenhamn, Denmark; Liv-Bente Romundstad, St. Olav’s University Hospital, Obstetrics and Gynecology, Trodenheim, Norway; Rolv Skjaerven, Medical Birth Register, Bergen Norway; Karl Gösta Nygren, Sophiahemmet, Sophiahemmet, Stockhom, Sweden; Mika Gissler, National Inst. Health and Welfare, THL, Helsinki, Finland; Aila Tiitinen, Helsinki University Central Hospital, Obstetrics and Gynecology, Helsinki, Finland.

###

A copy of the abstract is available at www.smfmnewsroom.org/annual-meeting/meeting-abstracts/ and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com,  202-374-9259 (cell) or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine.

Abstract 30: Perinatal outcome in singletons born after replacement of frozen/thawed embryos

Ulla-Britt Wennerholm¹, Anna-Karina Henningsen², Liv-Bente Romundstad³, Rolv Skjaerven⁶, Karl Gösta Nygren⁷, Mika Gissler⁴, Aila Tiitinen⁵, Anja Pinborg²

¹ Sahlgrenska University Hospital, Obstetrics and Gynecology, Göteborg, Sweden, ² Rigshospitalet, Fertility Clinic, Köpenhamn, Denmark, ³ St Olav’s University Hospital, Obstetrics and Gynecology, Trondheim, Norway, ⁴ National Inst Health and Welfare, THL, Helsinki, Finland, ⁵ Helsinki Univ Central Hospital, Obstetrics and Gynecology, Helsinki, Finland, ⁶ Medical Birth Register, Medical Birth Register, Bergen, Norway, ⁷ Sophiahemmet, Sophiahemmet, Stockholm, Sweden

OBJECTIVE: Frozen/thawed embryo replacement (FER) is increasingly used in IVF programs. The option of freezing spare embryos supports the strategy of single embryo transfer, thereby reducing the wellknown risk of adverse outcomes related to multiple births. The aim of the present study was to analyse the perinatal outcome in a Nordic study on singletons born after FER in comparison with singletons born after fresh IVF cycles and singletons in the general population.

STUDY DESIGN: Data were collected for all IVF treatments in Denmark, Norway and Sweden during 1984-2007. Data were crosslinked with the Nordic Medical Birth Registries. Singletons born after FER were compared with singletons born after fresh IVF and singletons in the general population. Outcomes were low birth weight (LBW), very LBW, preterm birth (PTB), very PTB, small for gestational age (SGA), macrosomia (> 4500g), LGA and stillbirth. Crude and adjusted odds ratios with 95% CI were calculated. Adjustment was made for maternal age, parity, child sex and year of birth.

RESULTS: There were 6653 children born after FER, 42287 singletons born after fresh IVF and 288868 singletons born after non IVF. As compared with the general population singletons born after FER had higher rate of PTB (AOR 1.4; 1.2-1.5), very PTB (AOR 1.8; 1.5-2.3), LBW (AOR 1.3; 1.1-1.4), very LBW (AOR 1.71.3-2.2), LGA (AOR 1.3; 1.2-1.5) and macrosomia (AOR 1.4;1.2-1.5). As compared with fresh IVF, singletons born after FER had lower rate of PTB (AOR 0.9-1.0), LBW (AOR 0.8; 0.7-0.9) and SGA (AOR 0.8; 0.7-0.9) and higher rate of LGA (AOR 1.4; 1.2-1.6) and macrosomia (AOR 1.5; 1.3-1.7). For other outcomes no significant differences were found.

CONCLUSION: This is the largest population based study on singletons born after FER. It confirms previous studies of a worse perinatal outcome as compared with the general population and a better outcome as compared with fresh IVF. However, the increased rate of LGA and macrosomia needs further studies.

The objective of the study was to determine if the implementation of “laborists” to provide around-the-clock coverage of labor and delivery would produce better outcomes. The study compared outcomes in hospitals with around-the-clock coverage versus hospitals whose coverage was based on need.

The study was a retrospective cohort study which covered live singleton births that were delivered in California between 2005-2006. There were certain variables that were taken into consideration to reduce the margin of error. Hospitals that had fewer than 1,200 deliveries were not considered for the study. The statistical analysis used included chi square and multivariable logistic regression. Hospitals were broken into two categories; one having a labor and delivery clinician “around-the-clock” while the other category was “as-needed”.

The sample size was very large as 740,019 singleton births met the study criteria, and the breakdown was as follows:

• Around-the-clock        274,106 births (37 percent of births)
• As-needed                   465,913 births (63 percent of births)

Data showed that around-the-clock hospitals had lower numbers of overall cesarean deliveries as well as primary cesarean delivery in both first time mothers and women who have given birth before. In addition, women who previously had a cesarean birth were more likely to attempt to achieve vaginal delivery in around-the-clock hospitals.

While the results indicate around-the-clock hospitals do have lower cesarean deliveries and better chances of a vaginal birth after a prior cesarean delivery, the overall feeling is that more research needs to be done before the laborist model can be given full credit for the rates.

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org/wp-content/uploads/2013/01/79-86.pdf and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com  202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine. 

Abstract 80: Labor and delivery coverage: around-the-clock or as-needed?

Yvonne Cheng¹, Arianna Cassidy¹, Blair Darney², Erika Catrell², Jonathan Snowden², Aaron Caughey²

¹University of California, San Francisco, Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA; ²Oregon Health and Science University, Obstetrics and Gynecology, Portland, OR

Objective: While the utility of hospitalists for medical units has been validated, it is unclear if the implementation of “laborists”, which provides around-the-clock coverage of Labor and Delivery (L&D) unit, is associated with improved outcomes. We aimed to compare obstetric outcomes in hospitals with around-the-clock coverage to hospitals whose coverage is based on need.

Study Design: This was a retrospective cohort study of singleton, term, live births delivered in California between 2005-2006. Hospitals with fewer than 1,200 deliveries per year were excluded. Hospitals were categorized based on L&D clinician coverage as “around-the-clock” or “as-needed.” Statistical analysis was performed using chi square test and multivariable logistic regression to adjust for potential confounding factors.

Results: There were 740,019 term, singleton, cephalic births that met study criteria. Of these, 274,106 (37%) delivered in hospitals with around-the-clock coverage and 465,913 (63%) delivered in hospitals with as-needed coverage. Compared to as-needed coverage, the overall cesarean delivery was lower in hospitals with around-the-clock coverage, as was primary cesarean delivery in both nulliparous and multiparous women (Table). The proportion of women who underwent a trial of labor after cesarean (TOLAC) and achieving vaginal birth after previous cesarean (VBAC) was higher with around-the-clock coverage (Table). Additionally, women were more likely to have labor induction with around-the-clock than as-needed coverage, though they remained to have lower odds of cesarean.

Conclusion: In California, around-the-clock L&D coverage is associated with decreased odds of cesarean delivery and increased likelihood of trial of labor after cesarean and achieving vaginal birth after previous cesarean but increased induction of labor. Whether the observed difference in outcome can be attributable to the implementation of a “laborist” model deserves further investigation, particularly as more hospitals are considering such staffing changes.

A study performed at Dignity Health, the fifth largest health care system in the United States with 31 obstetrical units, showed that the implementation of a standardized comprehensive maternal hemorrhage (CHP) protocol directed towards prevention and treatment of maternal hemorrhage significantly reduced blood product utilization and resulted in a 45% reduction in puerperal hysterectomy.

“The study shows that by following a standardized approach and having a dedicated hemorrhage cart allowing immediate availability of all the commonly used items in the event of a maternal hemorrhage, we are able to significantly reduce the amount of blood products needed as well reduce the severity of maternal hemorrhaging,” said Dr. Larry Shields, director of Maternal-Fetal Medicine at Marian Regional Medical Center in Santa Maria, Calif. “The study was conducted at hospitals with small and large obstetrical units as well as those local in major cities and in rural hospitals.”

There were 20,890 deliveries involved in the study and it produced significant percentages in blood product savings. By following the protocol there was a reduction of 22.4 percent in the number of red blood cells units, 31.4 platelets units, and a 58.1 percent reduction in the need for cryoprecipitate. The number of patients who required four or more units of blood was reduced by 88 percent.

There were four protocol stages designed to respond to varying degrees of blood loss for patients and one element of comprehensive maternal hemorrhage is the doctor needs to be on site beginning at stage 2. The stages are the following: Stage 1: bleeding greater than expected; Stage 2: bleeding not responding to conservative measures; Stage 3: blood loss in excess of 1500mL; and Stage 4: higher level of postpartum care monitoring.

“The study clearly shows that compliance leads to four major findings,” said Shields. “Less blood is needed, there is less morbidity, less hysterectomies and fewer patients needs large amounts of blood.”  Shields went on to say, “Unfortunately, maternal hemorrhage is a common problem and this is clearly a relatively simple and effective way to improve maternal safety.”

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org/wp-content/uploads/2013/01/79-86.pdf and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell) or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine. 

Abstract 84: Comprehensive maternal hemorrhage protocols reduce utilization of blood products and improve patient safety.

Larry Shields¹, Benda Chagolla¹, Janet Fulton¹, Barbara Pelletreau¹

¹Dignity Health, Patient Safety and Quality, San Francisco, CA

Objective: To improve patient safety and address a source of major morbidity, we initiated a comprehensive maternal hemorrhage (CHP) protocol within a large health care system with 31 different delivery units with >60,000 system-wide annual births. The objective of this study was to determine if the CHP reduced the severity of obstetrical hemorrhage.

Study Design: Patients were assigned to one of four protocol stages based on the degree of blood loss: Stage 0: normal ante/postpartum assessment; Stage 1: bleeding greater than expected for vaginal delivery (500mL) or C-section (1000mL); Stage 2: bleeding not responding to conservative measures, and required physician presence, and Stage 3: blood loss in excess of 1500mL. Interventions and transfusion recommendations were specific to the patient’s stage of blood loss. Two time periods were compared: a 2-month baseline, and a second 2- month assessment 6 months after system-wide implementation of the CHP. A dedicated perinatal nurse specialist at each facility prospectively collected outcomes data.

Results: There were 20,890 deliveries during the two study periods. Relative to baseline, there was a significant reduction in blood product utilization (p = 0.04), pRBCs 22.4%, platelets 31.4%, FFP 43.2% and cryoprecipitate 58.1%. The number of patients that required ≥ 4 units of pRBCs was reduced by 88%. There was a concomitant 50% reduction in the number of patient that required puerperal hysterectomy (p = 0.01).

Conclusion: Utilization of a CHP in a large health care system significantly reduced the number of blood products despite the fact that the protocol prescribed early transfusion. Further, there was a reduction in the severity of maternal hemorrhage, and the rate of puerperal hysterectomy. These findings suggest that protocol interventions reduced the need for aggressive surgical treatment and reduced maternal morbidity. These data support the implementation of systematic treatment protocols directed towards prevention and treatment of maternal hemorrhage.

This randomized study The Twin Birth Study: a multicenter RCT of planned cesarean section and planned vaginal birth for twin pregnancies 320 to 386/7 weeks, should help women understand that a planned vaginal birth is as safe as a planned cesarean section as long as the first twin is situated head first.

“The results of the study show that vaginal birth is safe and should continue to be offered to women who are pregnant with twins,” said Dr. Jon Barrett of Sunnybrook Health Science Centre, University of Toronto, Women and Babies Program, and one of the study’s authors. “There’s no evidence that a cesarean section is better for the babies or you.”

Researchers studied more than 2800 women from 26 countries; and compared 1398 planned C-section births to 1406 planned vaginal births. Vaginal births were induced, and only twins 32-38 weeks—with the first twin situated head first—were eligible.

Their research reveals no advantage in choosing cesarean births in these types of twins. In fact, planned cesarean birth does not decrease—or increase—neither perinatal/neonatal death nor serious neonatal morbidity versus planned vaginal birth.

“My advice to a woman pregnant with twins is that she should attempt to find an OBGYN that is trained in vaginal birth, as there is no harm,” said Barrett.

In addition to Barrett, the study was conducted by nine other doctors based in Canada: Elizabeth Aztalos and Mary Hannah of Sunnybrook Health Science Centre, University of Toronto, Women and Babies Program); B. Anthony Armson and Scott Farrell of Dalhousie University, Obstetrics & Gynecology in Halifax; Andy Willan (University of Toronto, Child Health Evaluative Sciences, Sickkids Research Institute), Ks Joseph (University of British Columbia, Obstetrics & Gynecology, Vancouver); Eileen Hutton (McMaster University, Faculty of Health Sciences, Hamilton); Alexander Allen (Dalhousie University, Paediatrics); Arne Ohlsson (Mt. Sinai Hospital, University of Toronto, Paediatrics); Sue Ross (University of Alberta, Obstetrics & Gynecology, Edmonton); Amiram Gafni (McMaster University, Clinical Epidemiology & Biostatistics) and Nan Okun (Mt. Sinai Hospital, University of Toronto, Obstetrics & Gynecology).

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org/wp-content/uploads/2013/01/1-8.pdf and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine. 

Abstract 7: The Twin Birth Study: a multicenter RCT of planned cesarean section(CS) and planned vaginal birth (VB) for twin pregnancies 320 to 386/7 weeks.

Jon Barrett¹, Elizabeth Aztalos¹, Andy Willan², Ks Joseph⁵, B. Anthony Armson³, Eileen Hutton⁴, Alexander Allen⁸, Arne Ohlsson⁶, Sue Ross⁷, Scott Farrell³, Amiram Gafni⁹, Nan Okun¹⁰, Mary Hannah¹

¹Sunnybrook Health Science Centre, University of Toronto, Women and Babies Program, Toronto, ON, Canada; ²University of Toronto, Child Health Evaluative Sciences, Sickkids Research Institute, Toronto, ON, Canada;  ³Dalhousie University, Obstetrics & Gynecology, Halifax, ON, Canada; ⁴McMaster University, Faculty of Health Sciences, Hamilton, ON, Canada; ⁵University of British Columbia, Obstetrics & Gynecology, Vancouver, BC, Canada; ⁶Mt. Sinai Hospital, University of Toronto, Paediatrics, Toronto, ON, Canada; ⁷University of Alberta, Obstetrics & Gynecology, Edmonton, AB, Canada; ⁸Dalhousie University, Paediatrics, Halifax, NS, Canada; ⁹McMaster University, Clinical Epidemiology & Biostatistics, Hamilton, ON, Canada; ¹⁰Mt. Sinai Hospital, University of Toronto, Obstetrics & Gynecology, Toronto, ON, Canada.

Objective: To compare planned CS with planned VB for twins 320/7 to 386/7 weeks, if the first twin is cephalic.

Study Design: Prospective RCT. Eligibility: Twins 32 to 38+6weeks, live fetuses, Twin A cephalic, EFW 1500g- 4000g. Exclusion: Fetal reduction at >13 wks gestation, lethal fetal anomaly, contraindication to labour. Delivery planned between 375/7 to 386/7 weeks by CS or inducing labour. Primary composite outcome: perinatal/neonatal mortality and/or serious neonatal morbidity. 2800 patients required to detect reduction of primary outcome from 4% to

2%. Power 80%, 2-sided, α error of 0.05. A logistic model was used with generalized estimating equations to account for correlation between babies from the same pregnancy

Results: 2804 women randomized from 26 countries. 1398 to planned CS vs.1406 to planned VB. There was no significant difference between treatment groups. Fifty seven babies of

2781(2.05%) experienced the primary outcome in planned CS vs.52 of 2782 (1.87%) in planned

VB (OR1.098, CI 0.726 -1.663, p = 0.6569). There was no significant interaction between treatment group and parity, GA at randomization, mother’s age, presentation of twin B, Chorionicity, and country’s PNMR. Twin B more likely to experience the primary outcome

(OR=1.895, CI: 1.329-2.703, p=0.0003). The interaction between treatment group and birth order was not significant (OR; A=1.239; OR;B=1.030, p=0.6125). 89 9% of the women who planned CS delivered both babies by CS. 60.45% in planned VB delivered at least twin A vaginally. 4% of women in planned VB group delivered twin B by CS following VB of twin A. Women in the planned CS delivered earlier but had no increase in maternal mortality or morbidity compared to planned VB.

Conclusion: Planned CS in twins at 32-38 week does not decrease (or increase) perinatal/neonatal death or serious neonatal morbidity vs planned VB when the first twin is cephalic.

While 17P (17 alpha-hydroxyprogesterone caproate) has been shown to prevent premature delivery among about one-third of women with a singleton pregnancy who have experienced a prior preterm delivery, this latest research shows that 17P prescriptions can’t do the same for moms having twins, the authors say.

“We found that 17P was not effective in women with twin pregnancies and a short cervix (defined as less than 25 mm between 24 and 32 weeks),” says Philippe Deruelle, MD, with the Department of Obstetrics and Gynecology at Hôpital Jeanne de Flandre,  Université Lille 2, France, and one of the study’s authors.  “We actually seemed to have found an increase in the rate of preterm delivery before 32 weeks in the treatment group when compared to the non-treatment group.”

For the study reported in the abstract, entitled: Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial,Deruelle and his colleagues conducted their trial on 165 women over the age of 18 at 10 university hospitals between June 2006 and January 2010. Outcome data was available for 161 of the 165 (97.6%) women.

“Twins are very high risk for preterm delivery, in fact, 60 percent of twins are born too soon. We can’t assume that what works for singleton pregnancies will work with multiples such as twins or triplets,” says Edward R. B. McCabe, MD, PhD, March of Dimes senior vice president and medical director. “This research finding is valuable because it will guide the care of women with a multi-fetal pregnancy, and highlights the need to better understand how to prevent preterm births for multiples.”

Dr. Deruelle recommends that women who know they are pregnant with twins get an ultrasound to measure their cervical length, as this factor has shown to predict which women with twins are at higher risk for premature pregnancy.

Dr. McCabe will present Dr. Deruelle with the March of Dimes award for Best Abstract in Prematurity at the SMFM’s Annual Meeting.  2013 marks the 10^th year the March of Dimes award has been presented.

In addition to Dr. Deruelle, the study was conducted by Marie Victoire Senat, Hopital Bicêtre, Hopital Antoine Béclère, APHP, Paris Sud, Faculté de Medecine Paris XI, Department of Obstetrics and Gynecology in Clamart, France; Norbert Winer, Hôpital Mère-Enfant, Department of Obstetrics and Gynecology in Nantes, France; and Patrick Rozenberg, Hôpital Poissy Saint-Germain, Department of Obstetrics and Gynecology in Poissy, France.

# # #

A copy of the abstract is available http://www.smfmnewsroom.org/wp-content/uploads/2013/01/1-8.pdf and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com, 202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine.  

In 2013, the March of Dimes celebrates its 75^th Anniversary and its ongoing work to help babies get a healthy start in life.  Early research led to the Salk and Sabin polio vaccines that all babies still receive.  Other breakthroughs include new treatments for premature infants and children with birth defects.  About 4 million babies are born each year in the United States, and all have benefitted from March of Dimes lifesaving research and education. The March of Dimes is the leading nonprofit organization for pregnancy and baby health. With chapters nationwide and its premier event, March for Babies®, the March of Dimes works to improve the health of babies by preventing birth defects, premature birth and infant mortality. For the latest resources and information, visit marchofdimes.com or nacersano.org.

Abstract 3: Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial

Marie Victoire Senat ¹, Philippe Deruelle ², Norbert Winer ³, Patrick Rozenberg ⁴

¹ Hopital Bicêtre, Hopital Antoine Béclère, APHP, Paris Sud, Faculté de Medecine Paris XI, Department of Obstetrics and Gynecology, Clamart, France; ² Hôpital Jeanne de Flandre, CHU Lille, F-59000, EA2694, UDSL, Université Lille Nord de France, Department of Obstetrics and Gynecology, Lille, France; ³ Hôpital Mère-Enfant, Department of Obstetrics and Gynecology, Nantes, France; ⁴ Hôpital Poissy Saint-Germain, Department of Obstetrics and Gynecology, Poissy, France.

OBJECTIVE: To evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce the risk of preterm delivery in asymptomatic twin pregnancy with short cervix.

STUDY DESIGN: This open-label multicenter randomized controlled trial took place at 10 university hospitals between June 2006 and January 2010. Women older than 18 years and carrying twins were eligible between 24+0 through 31+6 weeks of gestation if they were asymptomatic, presented a cervical length less than 25 mm as measured by routine transvaginal ultrasound and provided a written informed consent. Women were randomly assigned in a 1:1 ratio to receive 500 mg of intramuscular 17P, and repeated twice a week until 36 weeks or preterm delivery, whichever occurred first, or to no treatment with 17P (control group). The primary outcome was time from randomization to delivery.

RESULTS: Maternal characteristics of the 82 women in the 17P group and the 83 women in the control group were similar. Outcome data were available for 161 of the 165 women (97.6%). The intent-to-treat analysis with censoring at last follow up showed no significant difference between the 17P and controls group in median [Q1-Q3] time to delivery (45 [26-62] and 51 [36-66] days, respectively; mean difference, ­- 7; 95% CI, – 15; +1). Treatment with 17P was associated with a significantly increase in the rate of preterm deliveries before 32 weeks of gestation (29% vs 12%, p0.007), but not before 37 weeks of gestation (80% vs 77%, p=0.70) or 34 weeks of gestation (44%vs 28%, p=0.10). Median [Q1-Q3] birth weight did not differ between 17P and controls groups for twin 1 (2120 [1750-2471]g and 2215 [1982-2535] g, p=0,06) but differ significantly for twin 2 (2090 [1540-2425] and 2230 [1985-2535] g, p=0,027). There was a non-significant trend to an increase of neonatal morbidity in a 17P group.

CONCLUSION: 17P is ineffective in women with asymptomatic twins and short cervix for prevention of preterm delivery and possibly harmful.

In his study Dr. William Grobman of Northwestern University, presenting for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, studied 115,502 women over a three year period to see if adverse obstetric outcomes and provisions in obstetric care were affected by race or ethnicity. The study encompassed 25 hospitals and data on deliveries was gathered on 365 randomly selected days. Race and ethnicity were categorized as Non-Hispanic White (52,040), Non-Hispanic Black (23,878), Hispanic (27,291) or Asian (5,999).

Dr. Grobman then looked at associations between race/ethnicity and post-partum hemorrhage, peripartum infection, and severe perineal laceration; these were controlled for demographic differences between racial/ethnic groups and for hospital of delivery. Associations between race/ethnicity and types of obstetric care were also considered.

According to his findings, NHW women were least likely to experience postpartum hemorrhage or peripartum infection, and NHB women were least likely to experience severe perineal laceration. Dr. Grobman found these differences held after controlling for demographic characteristics and hospital of delivery.

“The key thing is there are differences in outcomes related to race or ethnicity not explained by patient characteristics or hospital,” said Dr. Grobman. “There are also racial/ethnic disparities in types of intrapartum care that patients receive.”

Aspects of care considered during the study included cesarean delivery, labor induction, dilation at admission, length of pushing, and maximum dose of oxytocin.

Dr. Grobman performed this study for the Maternal-Fetal Medicine Units Network, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md.

###

A copy of the abstract is available at www.smfmnewsroom.org/annual-meeting/meeting-abstracts/ and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com,  202-374-9259 (cell) ), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine.

Abstract 32: Racial and ethnic disparities in adverse obstetric outcomes and in the provision of obstetric care

William Grobman¹

¹Maternal-Fetal Medicine Units Network, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD

OBJECTIVE: To evaluate whether racial/ethnic disparities exist in adverse obstetric outcomes and in the provision of obstetric care, and if so, whether these disparities are explained by differences in patient or hospital characteristics.

STUDY DESIGN: We analyzed data abstracted concurrently from deliveries on 365 randomly selected days at 25 hospitals over a 3-year period. Race/ethnicity was categorized as Non-Hispanic White (NHW), Non-Hispanic Black (NHB), Hispanic, or Asian. Associations between race/ethnicity and postpartum hemorrhage (PPH), peripartum infection (INF), and severe perineal laceration (LAC) at SVD were estimated by univariable analysis, and after controlling for demographic differences among racial/ethnic groups and for hospital of delivery in fixed effects logistic regressions. Similarly, associations between race/ethnicity and types of obstetric care (eg, episiotomy) relevant to the adverse outcomes were compared in both univariable and multivariable analyses.

RESULTS: Of 115,502 studied women, 95% were classified according to one of the defined race/ethnicity categories. Disparities for all outcomes were observed, with NHW women least likely to experience PPH or INF, and NHB women least likely to experience LAC (Table, P < 0.001 for all). These disparities persisted after controlling for differences in demographic characteristics as well as hospital of delivery. Every aspect of obstetric care that was examined also was significantly different according to race/ethnicity (Table, P < .001 for all), even after controlling for demographic characteristics and hospital of delivery. There were no significant interactions between race/ethnicity and hospital of delivery.

CONCLUSION: Racial/ethnic disparities exist for adverse obstetric outcomes and in the provision of obstetric care, and do not appear to be explained by differences in demographic characteristics or by delivery hospital.

The study was conducted by the Perinatal Ireland Research Consortium, a nationwide collaborative research network comprising of the seven largest academic obstetric centers in Ireland. The PORTO Study, which was funded by the Health Research Board (HRB) in Ireland, investigated the optimal management of the IUGR fetus.

Between January 2010 and June 2012, the PORTO Study recruited 1,200 pregnancies with babies who were affected by intrauterine growth restriction, defined as having an EFW on ultrasound below the 10th centile for gestation. The study aimed to challenge whether this traditional definition on its own really matters in predicting poor pregnancy outcome. All eligible pregnancies underwent serial ultrasound evaluation at 2-week intervals until birth. Outcomes for mothers and their babies were recorded.

“Our study demonstrates that almost all of the adverse outcomes associated with having a growth restricted fetus occur in the group of pregnancies with EFW less than the 3^rd centile, or when additional abnormal ultrasound features are found,” said Dr. Julia Unterscheider of the Royal College of Surgeons in Ireland.

Dr. Sean Daly, a senior co-author of the study further suggested, “For example, having an EFW less than the 10^th centile, but greater than the 3^rd centile, together with otherwise normal ultrasound features, was almost always associated with delivery of a normal healthy baby.”

Of 1,200 recruited pregnancies with EFW below the 10^th centile, 78 percent were enrolled before 34 weeks’ gestation and detailed outcomes were obtained on 98 percent of all patients. Overall, there were four stillbirths and four neonatal deaths corresponding to an overall perinatal mortality rate of 7.2 per 1,000 births, but all of these deaths occurred in the sub-group of pregnancies with EFW less than the 3^rd centile. There were very few adverse outcomes found in the group with EFW between the 3^rd and 10^th centiles and in whom other ultrasound features were normal.

This study suggests more precise criteria for the diagnosis of true IUGR based on pregnancy outcomes and challenges the reader to re-think the traditional cut-offs used for the definition of intrauterine growth restriction. Professor Fergal Malone, Chairman of the Perinatal Ireland Research Consortium commented, “The major benefit of this study is the potential to radically change the focus and intensity of current methods of fetal surveillance for the apparently small fetus diagnosed prenatally.”

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org/wp-content/uploads/2013/01/18-26.pdf and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine. 

Abstract 25: Does having an EFW less than the 10th centile really matter? Results of the National Multicenter Prospective PORTO trial

Julia Unterscheider¹, Sean Daly², Michael Geary³, Mairead Kennelly⁴, Fionnuala McAuliffe⁵, Keelin O’Donoghue⁶, Alyson Hunter⁷, John Morrison⁸, Gerard Burke⁹, Patrick Dicker¹⁰, Elizabeth Tully¹, Fergal Malone¹

¹Royal College of Surgeons in Ireland, Obstetrics & Gynecology, Dublin, Ireland; ²Coombe Women and Infants University Hospital, Obstetrics & Gynecology, Dublin, Ireland; ³Rotunda Hospital, Obstetrics & Gynecology, Dublin, Ireland; ⁴Coombe Women and Infants University Hospital, UCD Center for Human Reproduction, Dublin, Ireland; ⁵National Maternity Hospital, UCD Obstetrics & Gynecology, School of Medicine and Medical Science, Dublin, Ireland;        ⁶University College Cork, Cork University Maternity Hospital, Obstetrics & Gynecology, Cork, Ireland; ⁷Royal Jubilee Maternity Hospital, Obstetrics & Gynecology, Belfast, Ireland;  ⁸National University of Ireland, Obstetrics & Gynecology, Galway, Ireland; ⁹Mid- Western Regional Maternity Hospital, Obstetrics & Gynecology, Limerick, Ireland; ¹⁰Royal College of Surgeons in Ireland, Epidemiology & Public Health, Dublin, Ireland.

OBJECTIVE: The PORTO Trial is a multicenter prospective trial conducted at the seven largest obstetric centers in Ireland, with its goal being to evaluate optimal management of the IUGR fetus. For the purposes of the Trial, IUGR was defined as EFW less than the 10^th centile. It is unclear however whether this definition is of clinical significance. The objective of this analysis is to document the outcomes of this population.

STUDY DESIGN: A total of 1,056 ultrasound-dated singleton pregnancies with EFW <10th centile were recruited between 24 0/7 and 36 6/7 weeks ‘gestation between January 2010 and June 2012. Perinatal and early neonatal outcomes were documented for all participants.

RESULTS: Of 1,056 pregnancies with EFW <10th centile at recruitment, 820 (78%) remained <10th centile until delivery. 492 (47%) had abnormal umbilical artery (UA) Doppler’s and 82 (8%) developed UA AEDF or REDF. Table 1 summarizes the maternal and fetal characteristics.

Mean gestational age (GA) at enrollment and delivery were 29.8 and 37.6 weeks, respectively. There were 8 aneuploidies and 40 congenital anomalies. The overall perinatal mortality rate in this cohort was 14.2 per 1000 births. Among the normally formed infants with normal karyotype, there were 6 stillbirths (1:170) and 5 neonatal deaths (1:200).

CONCLUSION: Having an EFW less than the 10th centile is a transient finding in 22% of pregnancies. For the remaining 78% with persistently low EFW, constitutionally small size, rather than pathologic IUGR, is by far the most likely outcome. This calls into question the utility of EFW less than the 10th centile as a definition for possible IUGR. A careful evaluation of possible underlying structural or karyotypical abnormalities is warranted in these pregnancies.