Impact of discontinuing oxytocin in active labour on neonatal morbidity: an open-label, multicentre, randomised trial.

BACKGROUND: Oxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity. METHODS: STOPOXY was a multicentre, randomised, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4 cm dilation were randomly assigned 1:1 to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6 cm) or continuous oxytocin (administration of oxytocin continued until delivery). Randomisation was stratified by centre and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth less than 7·10, a base excess greater than 10 mmol/L, umbilical arterial lactates greater than 7 mmol/L, a 5-min Apgar score less than 7, or admission to the neonatal intensive care unit. Efficacy and safety was assessed in participants who were randomly assigned (excluding those who withdrew consent or were deemed ineligible after randomisation) and had reached a cervical dilation of at least 6 cm. This trial is registered with ClinicalTrials.gov, NCT03991091. FINDINGS: Of 2459 participants randomly assigned between Jan 13, 2020, and Jan 24, 2022, 2170 were eligible to receive the intervention and were included in the final modified intention-to-treat analysis. The primary outcome occurred for 102 (9·6%) of 1067 participants (95% CI 7·9 to 11·5) in the discontinuous oxytocin group and for 101 (9·2%) of 1103 participants (7·6 to 11·0) in the continuous oxytocin group; absolute difference 0·4% (95% CI -2·1 to 2·9); relative risk 1·0 (95% CI 0·8 to 1·4). There were no clinically significant differences in adverse events between the two groups of the safety population. INTERPRETATION: Among participants receiving oxytocin in early labour, discontinuing oxytocin when the active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared with continuous oxytocin. FUNDING: French Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique-Hôpitaux de Paris.

Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.

BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).

Meconium-stained amniotic fluid and neonatal morbidity in nulliparous patients with prolonged pregnancy.

INTRODUCTION: Our objective was to study the strength of the association between meconium-stained amniotic fluid and severe morbidity among neonates of nulliparas with prolonged pregnancies. MATERIAL AND METHODS: This was a secondary analysis of the NOCETER randomized trial that took place between 2009 and 2012 in which 11 French maternity units included 1373 nulliparas at 41+0 weeks of gestation onwards with a single live fetus in cephalic presentation. This analysis excluded patients with a cesarean delivery before labor and those with bloody amniotic fluid or of unreported consistency. The principal end point was a composite criterion of severe neonatal morbidity (neonatal death, 5-minute Apgar <7, convulsions in the first 24 h, meconium aspiration syndrome, mechanical ventilation ≥24 h, or neonatal intensive care unit admission for 5 days or more). The neonatal outcomes of pregnancies with thin or thick meconium-stained amniotic fluid were compared with those with normal amniotic fluid. The association between the consistency of the amniotic fluid and neonatal morbidity was tested by univariate and then multivariate analysis adjusted for gestational age at birth, duration of labor, and country of birth. RESULTS: This study included 1274 patients: 803 (63%) in the group with normal amniotic fluid, 196 (15.4%) in the thin amniotic fluid group, and 275 (21.6%) in the thick amniotic fluid group. The neonates of patients with thick amniotic fluid had higher rates of neonatal morbidity than those of patients with normal amniotic fluid (7.3% vs. 2.2%; p < 0.001; adjusted relative risk [aRR] 3.3, 95% confidence interval [CI] 1.7-6.3), but those of patients with thin amniotic fluid did not (3.1% vs. 2.2%; p = 0.50; aRR 1.0, 95% CI, 0.4-2.7). CONCLUSIONS: Among nulliparas at 41+0 weeks onwards, only thick meconium-stained amniotic fluid is associated with a higher rate of severe neonatal morbidity.

Gestational weight gain adequacy among twin pregnancies in France.

The objective of this paper is to describe gestational weight gain (GWG), to assess the applicability of the 2009 Institute of Medicine (IOM) guidelines, and to derive a GWG adequacy classification within a French cohort. We included twins from the national, prospective, population-based JUmeaux MODe d'Accouchement (JUMODA) cohort study (2014-2015). Following the IOM approach, we selected a 'standard' population of term pregnancies with 'optimal' birthweight (≥2500 g; n = 2562). GWG adequacy (insufficient; adequate; excessive) was defined using IOM recommendations (normal body mass index [BMI]: 16.8-24.5 kg [also utilized for underweight BMI]; overweight: 14.1-22.7 kg; obese: 11.4-19.1 kg). Additionally, using the IOM approach, we determined the 25th and 75th percentiles of GWG in our standard population to create a JUMODA-derived GWG adequacy classification. GWG and GWG adequacy were described, overall and by BMI and parity. In the JUMODA standard population of term twin livebirths with optimal birthweight, mean GWG was 16.1 kg (standard deviation 6.3). Using IOM recommendations, almost half (46.5%) of the women had insufficient and few (10.0%) had excessive GWG, with similar results regardless of BMI or parity. The 25th and 75th percentiles of GWG in the JUMODA standard population (underweight: 13-21 kg; normal weight: 13-20 kg; overweight: 11-19 kg; obese: 7-16 kg) were lower than the IOM recommendations. The IOM recommendations classified a relatively high percentage of French women as having insufficient and a low percentage as having excessive GWG. Additional research to evaluate recommendations in relation to adverse perinatal outcomes is needed to determine whether the IOM recommendations or the JUMODA-derived classification is more appropriate for French twin gestations.

Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial.

BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. OBJECTIVE: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. RESULTS: Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss-related outcomes.

Perinatal mortality and morbidity, timing and route of delivery in monoamniotic twin pregnancies: a retrospective cohort study.

PURPOSE: Monoamniotic twin pregnancies are at high risk of perinatal complications and fetal loss. The objective of this study is to describe the management and outcomes of monoamniotic twin pregnancies in a French university obstetrics department. METHODS: Retrospective review of all consecutive monoamniotic twin pregnancies managed between 1992 and 2018 in a level-3 university hospital maternity unit. Antenatal variables, gestational age and other neonatal characteristics at delivery, mode of delivery, and its reason were recorded, together with outcomes, including a composite adverse neonatal outcome. RESULTS: Overall, 46 monoamniotic twin pregnancies (92 fetuses) were identified during the study period. Among them, 27 fetal losses and 2 early neonatal deaths were reported. Congenital abnormalities accounted for 33.3% of the 27 fetal losses, and unexpected fetal deaths for 29.6%. Among the 37 women who gave birth to 65 live infants at 23 or more weeks of gestation, 17 had cesarean and 19 vaginal deliveries. Overall and composite adverse neonatal outcomes did not differ significantly for the 33 children born vaginally and the 31 by cesarean deliveries. The prospective risk of intrauterine death in all 92 fetuses reached its nadir of 1.8% at 336/7 weeks. CONCLUSION: This series confirms the still high risk of fetal and neonatal death of these twins and shows that congenital abnormalities but also unexpected fetal deaths account for the majority of pre- and postnatal mortality. Our data suggest that vaginal delivery of monoamniotic twins is safe and that delivery for uncomplicated monoamniotic twins should be considered around 33 weeks of gestation, but not later than 35 weeks.

Increased risk of severe maternal morbidity in women with twin pregnancies resulting from oocyte donation.

STUDY QUESTION: Is there a difference in the risk of serious maternal complications during pregnancy and the postpartum in twin pregnancies according to mode of conception: natural conception, non-IVF fertility treatment, IVF, ICSI or oocyte donation? SUMMARY ANSWER: Women with twin pregnancies after medically assisted reproduction (MAR) had an overall risk of serious maternal complications 30% higher compared with women with natural twin pregnancies, and this association varied according to the MAR procedure; the risk was increased by 50% with IVF using autologous oocytes and by 270% with oocyte donation. WHAT IS KNOWN ALREADY: IVF has been reported as a risk factor for serious maternal complications in several concordant studies of singleton pregnancies. For twin pregnancies, this association is less well documented with imprecise categorisation of the mode of conception, and results are contradictory. STUDY DESIGN, SIZE, DURATION: This is a secondary analysis of the national, observational, prospective, population-based cohort study of twin pregnancies (JUmeaux Mode d'Accouchement), which took place in France from 10 February 2014 through 1 March 2015. All French maternity units performing more than 1500 annual deliveries were invited to participate, regardless of their academic, public or private status or level of care. Of the 191 eligible units, 176 (92%) participated. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with a twin pregnancy who gave birth at or after 22 weeks of gestation were eligible (N = 8823 women included). We excluded women whose mode of conception was unknown (n = 75). Serious maternal complications were regrouped within the recently emerged concept of severe acute maternal morbidity (SAMM), as a binary composite outcome. The exposure of interest was the mode of conception, studied in five classes: natural conception (reference group), non-IVF fertility treatment including insemination and ovarian stimulation, IVF with autologous oocyte, ICSI with autologous oocyte and oocyte donation. To assess the association between the mode of conception and SAMM, we used multivariate logistic regression to adjust for confounders. Structural equation modelling (SEM) was used to explore the contribution to this association of potential intermediate factors, i.e. factors possibly caused by the mode of conception and responsible for SAMM: non-severe pre-eclampsia, placenta praevia and planned mode of delivery. MAIN RESULTS AND THE ROLE OF CHANCE: Among the 8748 women of the study population, 5890 (67.3%) conceived naturally, 854 (9.8%) had non-IVF fertility treatment, 1307 (14.9%) had IVF with autologous oocytes, 368 (4.2%) had ICSI with autologous oocytes and 329 (3.8%) used oocyte donation. Overall, 538 (6.1%) developed SAMM. Women with twin pregnancy after any type of MAR had a higher risk of SAMM than those with a natural twin pregnancy, after adjustment for confounders (7.9% (227/2858) compared to 5.3% (311/5890), adjusted odds ratio (aOR) 1.3, 95% CI 1.1-1.6). This association varied according to the MAR procedure. The risk of SAMM was higher among women with IVF using either autologous oocytes (8.3%; 108/1307) or oocyte donation (14.0%; 46/329) compared with the reference group (respectively aOR 1.5, 95% CI 1.1-1.9 and aOR 2.7, 95% CI 1.8-4.1) and higher after oocyte donation compared with autologous oocytes (aOR 1.7, 95% CI 1.1-2.6). Conversely, the risk of SAMM for women with non-IVF fertility treatment (6.2%; 53/854) and with ICSI using autologous oocytes (5.4%; 20/368) did not differ from that of the reference group (5.3%; 311/5890) (respectively aOR 1.1, 95% CI 0.8-1.5 and aOR 0.9, 95% CI 0.6-1.5). The tested intermediate factors poorly explained these increased risks. LIMITATIONS, REASONS FOR CAUTION: Beyond the confounders and intermediate factors considered in our analysis, specific causes of infertility and specific aspects of infertility treatments may explain the differences in the risk of SAMM by mode of conception. However, these data were not available. WIDER IMPLICATIONS OF THE FINDINGS: Our study showed an increased risk of SAMM in women with twin pregnancies after MAR, notably after IVF using autologous oocytes and particularly after oocyte donation. To avoid unnecessary exposure to the high-risk combination of MAR and multiple pregnancies, transfer of a single embryo should be encouraged whenever possible. Knowledge of these differential risks may inform discussions between clinicians and women about the mode of conception and help to optimise obstetric care for women in subgroups at higher risk. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by a grant from the French Ministry of Health (Programme Hospitalier de Recherche Clinique, AOM2012). There are no competing interests. TRIAL REGISTRATION NUMBER: Not applicable.

Use of the Robson classification to understand the increased risk of cesarean section in case of maternal obesity.

BACKGROUND: The aim of this study was to identify characteristics of pregnant women with obesity that contribute to increased cesarean rate. METHODS: Retrospective cohort in a single academic institution between 2012 and 2019. Women who delivered during this period were classified according to the Robson classification. Women with normal body mass index (N = 11,797) and with obesity (N = 2991) were compared. The contribution of each Robson group to the overall caesarean rate were compared. RESULTS: The overall cesarean rate was higher for women with (28.1%) than without (14.2%, p < 0.001) obesity. This result came mainly from Robson group 5a (history of one cesarean). After adjustment for medical factors within this group, the association between maternal obesity and cesarean during labor was significant. CONCLUSIONS: The higher cesarean rate in women with obesity is explained by Robson group 5a in which obesity is an independent risk factor of in labor cesarean delivery.

Double-balloon catheter versus prostaglandin for cervical ripening to induce labor after previous cesarean delivery.

PURPOSE: To compare the effectiveness of cervical ripening by a mechanical method (double-balloon catheter) and a pharmacological method (prostaglandins) in women with one previous cesarean delivery, an unfavorable cervix (Bishop score < 6), and a singleton fetus in cephalic presentation. METHODS: This retrospective study, reviewing the relevant records for the years 2013 through 2017, took place in two French university hospital maternity units. This study included women with one previous cesarean delivery, a liveborn singleton fetus in cephalic presentation, and intact membranes, for whom cervical ripening, with unfavorable cervix (Bishop score < 6) was indicated for medical reasons. It compared two groups: (1) women giving birth in a hospital that uses a protocol for mechanical cervical ripening by a double-balloon catheter (DBC), and (2) women giving birth in a hospital that performed pharmacological cervical ripening by prostaglandins. The principal endpoint was the cesarean delivery rate. The secondary outcome measures were maternal and neonatal outcomes. RESULTS: We compared 127 women with prostaglandin ripening to 117 women with DBC. There was no significant difference between the two groups for the cesarean rate (42.5% in the prostaglandin group and 42.7% in the DBC group; p = 0.973; crude OR 1.01 [0.61-1.68]; adjusted OR 1.55 [0.71-3.37]). The median interval between the start of ripening and delivery did not differ between the groups (28.7 h in the prostaglandin group vs 25.6 h in the DBC group; p = 0.880). Neonatal outcomes did not differ between the groups, either. There was one case of uterine rupture in the prostaglandin group, with no associated maternal or neonatal morbidity. There were no neonatal deaths. The postpartum hemorrhage rate was significantly higher in the DBC group. CONCLUSION: For cervical ripening for women with one previous cesarean, the choice of a pharmacological or mechanical protocol does not appear to modify the mode of delivery or maternal or neonatal morbidity.

Risk of severe maternal morbidity associated with cesarean delivery and the role of maternal age: a population-based propensity score analysis.

BACKGROUND: Short-term maternal complications of cesarean delivery remain uncertain because of confounding by indication. Our objective was to assess whether cesarean delivery is associated with severe acute intra- or postpartum maternal morbidity compared with vaginal delivery, overall and according to the timing of the cesarean. METHODS: We performed a case-control analysis using data from EPIMOMS, a prospective population-based study of deliveries at 22 gestation weeks or later from 6 regions of France in 2012-2013. Cases of intra- or postpartum severe acute maternal morbidity that were not a result of a condition present before delivery were compared with controls randomly selected in a 1/50 ratio. Associations between delivery modes and severe acute maternal morbidity were estimated in a propensity score-matched sample. RESULTS: Among 182 300 deliveries, we identified 1444 cases and 3464 controls. The proportion of cesarean delivery was significantly higher among cases than controls (36.0% v. 18.2%). In the propensity score-matched analysis, cesarean deliveries were significantly associated with a higher risk of severe acute maternal morbidity (adjusted odds ratio [OR] 1.8, 95% confidence interval [CI] 1.5-2.2). This association increased with maternal age and was particularly marked for women aged 35 years or older (adjusted OR 2.9, 95% CI 1.9-4.4). This increased risk was significant for cesarean deliveries during labour in women of all age groups and for those before labour only in women aged 35 years or older (adjusted OR 5.1, 95% CI 2.3-11.0). INTERPRETATION: Cesarean delivery is associated with a higher risk of severe acute maternal morbidity than vaginal delivery, particularly in women aged 35 years and older. Clinical decisions regarding delivery mode should account for this excess risk accordingly.

Long interpregnancy interval and mode of delivery.

PURPOSE: WHO sets 24 months as the ideal minimum interpregnancy interval (IPI) to minimize maternal and perinatal adverse outcomes. Some studies suggest that an interval longer than 59 months may affect these outcomes, but little is known about its influence on labor. The primary objective of this study was to compare the cesarean delivery rate between primiparous women with a long IPI and, on the one hand, primiparous women with an ideal minimum IPI of 18-24 months and, on the other hand, with nulliparous women. METHODS: This retrospective cohort study of 17 years included nulliparas and primiparas who gave birth to live singleton fetuses in cephalic presentation after 22 weeks of gestation. Women with an IPI < 18 months or from 24 to 59 months were excluded, as were women with planned cesarean. We analyzed three groups: primiparous women with a long IPI defined as > 59 months, primiparous women with an ideal minimum IPI (18-24 months), and nulliparous women. RESULTS: The study included 18,503 women: 1342 women in the "long IPI" group, 1388 in the "ideal minimum IPI" group, and 15,773 in the nulliparous women group. The cesarean delivery rate was significantly higher in the long compared to the ideal minimum IPI group [12.2% vs. 6.3%, respectively; aOR = 2.2 (95% CI 1.6-3.1)], but both groups had similar durations of labor, regardless of mode of delivery. Women in the long IPI group had significantly lower cesarean rates than nulliparous women [12.2% and 14.3%, respectively; aOR = 0.5 (95% CI 0.4-0.7)], and the nulliparous women had a significantly longer mean duration of labor. CONCLUSIONS: Primiparas with a long IPI, compared with ideal minimal IPI have a higher risk of cesarean delivery during labor. Compared with nulliparous women, primiparous women with a long IPI had a lower cesarean rate.

Neonatal morbidity associated with vaginal delivery of noncephalic second twins.

BACKGROUND: Management of noncephalic second twin delivery rests on the results of population-based retrospective studies of twin births that have shown higher neonatal mortality and morbidity for second twins with noncephalic, compared with cephalic, presentations after vaginal delivery of the first twin. Because these studies are flawed by data of questionable validity, do not report the obstetrical practices at delivery, and do not allow collection of potential confounding variables, we performed a national prospective study specially designed to evaluate the management of twins' delivery. OBJECTIVE: We sought to assess neonatal mortality and morbidity according to second twin presentation after vaginal birth of the first twin. STUDY DESIGN: The Jumeaux Mode d'Accouchement study was a nationwide prospective population-based cohort study of twin deliveries performed in 176 maternity units in France from February 2014 through March 2015. The primary outcome was a composite of intrapartum mortality and neonatal mortality and morbidity. Neonatal outcomes of second twins born ≥32 weeks of gestation after vaginal delivery of the first cephalic or breech twin were compared according to the noncephalic or cephalic second twin presentation. Multivariable logistic regression models controlled for potential confounders. Subgroup analyses were conducted according to the breech or transverse presentation of the noncephalic second twin, and gestational age at delivery, before or after 37 weeks of gestation. RESULTS: Among 3903 second twins enrolled in the study, 2384 (61.1%) were in cephalic and 1519 (38.9%) in noncephalic presentations, of whom 999 (25.6%) were in breech and 520 (13.3%) in transverse presentation. Composite neonatal mortality and morbidity did not differ between the noncephalic and cephalic group (47/1519 [3.1%] vs 59/2384 [2.5%]; adjusted odds ratio, 1.23; 95% confidence interval, 0.81-1.85). No significant difference between groups was shown for the primary outcome in subgroup analyses according to type of noncephalic second twin presentation or gestational age at delivery. Cesarean delivery rates for the second twin were lower in the breech than in the cephalic group (14/999 [1.4%] vs 75/2384 [3.1%], P = .003) and lower in the cephalic than in the transverse group (75/2384 [3.1%] vs 35/520 [6.7%], P < .001). CONCLUSION: Noncephalic and cephalic second twin presentations after vaginal delivery of the first twin ≥32 weeks of gestation are associated with similar low composite neonatal mortality and morbidity. Vaginal delivery of noncephalic second twin is a reasonable option.

Prognostic factors for assisted reproductive technology in women with endometriosis-related infertility.

BACKGROUND: Assisted reproductive technology is one of the therapeutic options offered for managing endometriosis-associated infertility. Yet, published data on assisted reproductive technology outcome in women affected by endometriosis are conflicting and the determinant factors for pregnancy chances unclear. OBJECTIVE: We sought to evaluate assisted reproductive technology outcomes in a series of 359 endometriosis patients, to identify prognostic factors and determine if there is an impact of the endometriosis phenotype. STUDY DESIGN: This was a retrospective observational cohort study, including 359 consecutive endometriosis patients undergoing in vitro fertilization or intracytoplasmic sperm injection, from June 2005 through February 2013 at a university hospital. Endometriotic lesions were classified into 3 phenotypes-superficial peritoneal endometriosis, endometrioma, or deep infiltrating endometriosis-based on imaging criteria (transvaginal ultrasound, magnetic resonance imaging); histological proof confirmed the diagnosis in women with a history of surgery for endometriosis. Main outcome measures were clinical pregnancy rates and live birth rates per cycle and per embryo transfer. Prognostic factors of assisted reproductive technology outcome were identified by comparing women who became pregnant and those who did not, using univariate and adjusted multiple logistic regression models. RESULTS: In all, 359 endometriosis patients underwent 720 assisted reproductive technology cycles. In all, 158 (44%) patients became pregnant, and 114 (31.8%) had a live birth. The clinical pregnancy rate and the live birth rate per embryo transfer were 36.4% and 22.8%, respectively. The endometriosis phenotype (superficial endometriosis, endometrioma, or deep infiltrating endometriosis) had no impact on assisted reproductive technology outcomes. After multivariate analysis, history of surgery for endometriosis (odds ratio, 0.14; 95% confidence ratio, 0.06-0.38) or past surgery for endometrioma (odds ratio, 0.39; 95% confidence ratio, 0.18-0.84) were independent factors associated with lower pregnancy rates. Anti-müllerian hormone levels <2 ng/mL (odds ratio, 0.51; 95% confidence ratio, 0.28-0.91) and antral follicle count <10 (odds ratio, 0.27; 95% confidence ratio, 0.14-0.53) were also associated with negative assisted reproductive technology outcomes. CONCLUSION: The endometriosis phenotype seems to have no impact on assisted reproductive technology results. An altered ovarian reserve and a previous surgery for endometriosis and/or endometrioma are associated with decreased pregnancy rates.

Posterior urethral valves and vesicoureteral reflux: can prenatal ultrasonography distinguish between these two conditions in male fetuses?

OBJECTIVE: The objective of the study was to evaluate prenatal sonographic signs that distinguish male fetuses with posterior urethral valves (PUV) from those with vesicoureteral reflux (VUR). METHODS: Prenatal data were retrospectively retrieved from all consecutive women delivering between 2003 and 2012 of a male newborn with a postnatal diagnosis of PUV or VUR. Prenatal parameters included fetal bladder characteristics, identification of a dilated posterior urethra, and change in shape and size in the fetal renal pelvis or ureter. RESULTS: One hundred thirty-six women gave birth to a male newborn with a postnatal diagnosis of PUV (n = 49) or VUR (n = 87). The presence of posterior urethral dilatation [21 (42.9%) fetuses versus 0 (0%), p = 0.000], a thickened fetal bladder wall [37 (75.5%) vs 4 (4.6%), p = 0.000], and anhydramnios [14 (28.6%) vs 0, p = 0.000] were strongly associated with the postnatal diagnosis of PUV. Change in shape and size in the fetal renal pelvis or ureter was observed in 15 (17.2%) of 87 children with VUR versus 1 (2.0%) out of 49 with PUV (p = 0.010). CONCLUSIONS: Prenatal ultrasound may differentiate with reasonable accuracy male fetuses with a postnatal diagnosis of PUV from those with VUR. © 2016 John Wiley & Sons, Ltd.

Diet or medically treated gestational diabetes: is there any difference for obstetrical and neonatal complications? A French cohort study.

OBJECTIVE: The aim of the present study was to determine specific obstetrical and neonatal complications associated with diet-treated gestational diabetes (DTGD) and medically treated gestational diabetes (MTGD). METHODS: This is a prospective cohort study of women followed in the Robert Debré Hospital (France, Paris) and who have given birth between 1 January, 2004, and 19 November, 2010. Clinical, biological, maternal and neonatal data were reported in the maternity database. Associations between obstetrical and neonatal complications and gestational diabetes were evaluated by estimating odd ratios (ORs) and their 95% CIs, using a logistic regression model. RESULTS: 16,244 pregnancies were included in the study. 1515 (9.3%) women had gestational diabetes: 1108 (7.3%) had DTGD, 243 (1.7%) had MTGD. After full adjustment, MTGD was associated with an increased risk of nonscheduled cesarean (ORnonscheduled=2.3; 95% CI: 1.6-3.3; P<0.001) while DTGD was not (ORnonscheduled=1.0; 95% CI: 0.8-1.3; P<0.96). Clinical macrosomia was positively associated with DTGD (OR=2; 95% CI: 1.7-2.4; P<0.0001) or MTGD (OR=2.9; 95% CI: 2.1-3.9; P<0.0001). CONCLUSION: This study confirms that macrosomia is the main complication of DTGD. By contrast, DTGD was not associated with neonatal hypoglycemia and cesarean, while these complications were associated with MTGD.

Population-based study of eclampsia: Lessons learnt to improve maternity care.

BACKGROUND: Among hypertensive disorders of pregnancy (HDP), eclampsia is a rare but serious event, often considered avoidable. Detailed assessment of the adequacy of care for the women who have eclampsia can help identify opportunities for improvement and for prevention of the associated adverse maternal and neonatal outcomes. OBJECTIVE: 1/ To estimate the incidence and describe the characteristics of women with eclampsia and to compare them with those of women with non-eclamptic hypertensive disorders of pregnancy (HDP)-related severe maternal morbidity (SMM) and of control women without SMM 2/ To analyse the quality of management in women who had eclampsia, at various stages of their care pathway. METHODS: It was a planned ancillary analysis of the EPIMOMS population-based study, conducted in six French regions in 2012-2013. Among the 182,309 maternities of the source population, all women with eclampsia (n = 51), with non-eclamptic HDP-related SMM (n = 351) and a 2% representative sample of women without SMM (n = 3,651) were included. Main outcome was the quality of care for eclampsia assessed by an independent expert panel at three different stages of management: antenatal care, care for pre-eclampsia and care for eclampsia. RESULTS: The eclampsia incidence was 2.8 per 10,000 (95%CI 2.0-4.0). Antenatal care was considered completely inadequate or substandard in 39% of women, as was pre-eclampsia care in 76%. Care for eclampsia was judged completely inadequate or substandard in 50% (21/42), mainly due to inadequate use of magnesium sulphate. CONCLUSION: The high proportion of inadequate quality of care underlines the need for an evidence-based standardisation of care for HDP.

[Preeclampsia: Guidelines for clinical practice from the French College of Obstetricians and Gynecologists]. / La pré-éclampsie : recommandations pour la pratique clinique du Collège national des gynécologues obstétriciens français.

OBJECTIVE: To identify strategies to reduce maternal and neonatal morbidity related to preeclampsia. MATERIAL AND METHODS: The quality of evidence of the literature was assessed following the GRADE® method with questions formulated in the PICO format (Patients, Intervention, Comparison, Outcome) and outcomes defined a priori and classified according to their importance. An extensive bibliographic search was performed on PubMed, Cochrane, EMBASE and Google Scholar databases. The quality of the evidence was assessed (high, moderate, low, very low) and recommendations were formulated as a (i) strong, (ii) weak or (iii) no recommendation. The recommendations were reviewed in two rounds with external reviewers (Delphi survey) to select the consensus recommendations. RESULTS: Preeclampsia is defined by the association of gestational hypertension (systolic blood pressure≥140mmHg and/or diastolic blood pressure≥90mmHg) and proteinuria≥0.3g/24h or a Proteinuria/Creatininuria ratio≥30mg/mmol occurring after 20 weeks of gestation. Data from the literature do not show any benefit in terms of maternal or perinatal health from implementing a broader definition of preeclampsia. Of the 31 questions, there was agreement between the working group and the external reviewers on 31 (100%). In general population, physical activity during pregnancy should be encouraged to reduce the risk of preeclampsia (Strong recommendation, Quality of the evidence low) but an early screening based on algorithms (Weak recommendation, Quality of the evidence low) or aspirin administration (Weak recommendation, Quality of the evidence very low) is not recommended to reduce maternal and neonatal morbidity related to preeclampsia. In women with preexisting diabetes or hypertension or renal disease, or multiple pregnancy, the level of evidence is insufficient to determine whether aspirin administration during pregnancy is useful to reduce maternal and perinatal morbidity (No recommendation, Quality of the evidence low). In women with a history of vasculo-placental disease, low dose of aspirin (Strong recommendation, Quality of the evidence moderate) at a dosage of 100-160mg per day (Weak recommendation, Quality of the evidence low), ideally before 16 weeks of gestation and not after 20 weeks of gestation (Strong recommendation, Quality of the evidence low) until 36 weeks of gestation (Weak recommendation, Quality of the evidence very low) is recommended. In a high-risk population, additional administration of low molecular weight heparin is not recommended (Weak recommendation, Quality of the evidence moderate). In case of preeclampsia (Weak recommendation, Quality of the evidence low) or suspicion of preeclampsia (Weak recommendation, Quality of the evidence moderate, the assessment of PlGF concentration or sFLT-1/PlGF ratio is not routinely recommended) in the only goal to reduce maternal or perinatal morbidity. In women with non-severe preeclampsia antihypertensive agent should be administered orally when the systolic blood pressure is measured between 140 and 159mmHg or diastolic blood pressure is measured between 90 and 109mmHg (Weak recommendation, Quality of the evidence low). In women with non-severe preeclampsia, delivery between 34 and 36+6 weeks of gestation reduces severe maternal hypertension but increases the incidence of moderate prematurity. Taking into account the benefit/risk balance for the mother and the child, it is recommended not to systematically induce birth in women with non-severe preeclampsia between 34 and 36+6 weeks of gestation (Strong recommendation, Quality of evidence high). In women with non-severe preeclampsia diagnosed between 37+0 and 41 weeks of gestation, it is recommended to induce birth to reduce maternal morbidity (Strong recommendation, Low quality of evidence), and to perform a trial of labor in the absence of contraindication (Strong recommendation, Very low quality of evidence). In women with a history of preeclampsia, screening maternal thrombophilia is not recommended (Strong recommendation, Quality of the evidence moderate). Because women with a history of a preeclampsia have an increased lifelong risk of chronic hypertension and cardiovascular complications, they should be informed of the need for medical follow-up to monitor blood pressure and to manage other possible cardiovascular risk factors (Strong recommendation, Quality of the evidence moderate). CONCLUSION: The purpose of these recommendations was to reassess the definition of preeclampsia, and to determine the strategies to reduce maternal and perinatal morbidity related to preeclampsia, during pregnancy but also after childbirth. They aim to help health professionals in their daily clinical practice to inform or care for patients who have had or have preeclampsia. Synthetic information documents are also offered for professionals and patients.

Effectiveness of episiotomy to prevent OASIS in nulliparous women at term.

OBJECTIVE: To assess the association between episiotomy and severe obstetric anal sphincter injury (OASIS) in nulliparous women at term according to the use of an instrument for delivery with control confounding by indication. METHODS: This was an observational retrospective cohort study including 12 346 women from 2004 to 2020. All nulliparous women with a cephalic singleton pregnancy were included. The primary outcome was the occurrence of OASIS. Association between episiotomy and OASIS was assessed by multivariate logistic regression with adjustment for confounding factors and stratification on the use of an instrument at delivery. Propensity score matching was used to account for indication bias. RESULTS: Among 12 346 women included, 7803 (63.2%) had an episiotomy and 4543 (36.8%) did not have an episiotomy; the rate of OASIS was similar in both groups (0.7%). After stratification on use of instrument, an association between episiotomy and OASIS was shown in the case of instrumental delivery (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.26-0.80) but not if the delivery was spontaneous (OR 0.76, 95% CI 0.29-1.98). The result was similar after matching on propensity score (in the case of operative vaginal delivery: OR 0.20, 95% CI 0.10-0.75). CONCLUSION: Episiotomy seems to be a protective factor for OASIS in nulliparous woman at term only in the case of operative vaginal delivery.

Mother-child separation after twin birth in a maternity unit with an appropriate level of neonatal care.

OBJECTIVE: To evaluate the mother-child separation rate in twin pregnancies delivered in maternity units offering an appropriate level of neonatal care. METHODS: JUMODA is a French, prospective, population-based cohort study of twin deliveries, including 7998 women who gave birth in maternity units with appropriate levels of neonatal care based on thresholds for weeks of gestational age (wGA) and birth weight according to French guidelines: level I (≥36 wGA), IIA (≥34 wGA), IIB (≥32 wGA and ≥ 1500 g), and IIII (<32 wGA or < 1500 g). The primary outcome was mother-child separation, defined as the transfer of at least one twin or the mother to another hospital. RESULTS: Mother-child separation occurred in 2.1% of pregnancies. This rate was significantly higher in level I (4.8%, 95% confidence interval [CI] 1.5-12.5) and IIA (3.4%, 95% CI 2.4-4.7) compared with level IIB (1.6%, 95% CI 1.1-2.3) and level III maternity units (2.1%, 95% CI 1.9-2.8). In level IIA units, the rate of mother-child separation was higher for babies born between 34 and 36 wGA (8.3%) than for those born at 36 wGA or beyond (1.7%). In level IIb, the rate of mother-child separation for babies born between 32 and 34 wGA (7.5%) was higher than for those born between 34 and 36 wGA (2.1%) and at 36 wGA or beyond (0.9%). CONCLUSION: Mother-child separation rates were low but differed by level of care. By using specific thresholds for twins to define levels of care, rather than data from singleton births, one-fifth of mother-child separations could have been avoided.