Cervical ripening balloon compared with vaginal dinoprostone for cervical ripening in obese women at term: A prospective cohort study.

OBJECTIVE: To evaluate vaginal delivery in obese women who underwent cervical ripening at term using a dinoprostone vaginal insert or a cervical ripening balloon (CRB), and to assess maternal and neonatal morbidity according to the method. METHODS: A prospective cohort study including obese women with a live singleton fetus in cephalic presentation who required cervical ripening at term (≥37 weeks) for maternal and/or fetal disease using a dinoprostone vaginal insert or a CRB. The primary outcome was vaginal delivery. Secondary outcomes were a favorable cervix (Bishop score >6) after 24 h, the time from device insertion to delivery, and composite maternal and neonatal morbidity. RESULTS: In total, 135 consecutive women were analyzed (107 CRB, 79.3%; 28 dinoprostone vaginal insert, 20.7%). Vaginal delivery (86 [80.4%] after CRB vs 19 [67.9%] after dinoprostone vaginal insert; P = 0.248), favorable cervix within 24 h after device placement (52 [48.6%] vs 17 [60.7%]; P = 0.264), and maternal morbidity (12 [11.2%] vs 4 [14.3%]; P = 0.646) were similar between the groups. The time from device insertion to delivery also did not differ between the groups. Neonatal morbidity was significantly higher after the dinoprostone vaginal insert (11 [39.3%] vs 20 [18.7%]; P = 0.030). Cervical ripening using the dinoprostone vaginal insert, compared with the CRB, was significantly associated with neonatal morbidity (adjusted odds ratio 4.00, 95% confidence interval 1.34-12.5), but not with maternal morbidity (adjusted odds ratio 1.23, 95% confidence interval 0.30-4.38). CONCLUSIONS: Vaginal delivery, a favorable cervix after 24 h, the time from device insertion to delivery, and maternal morbidity did not significantly differ between the CRB and the dinoprostone vaginal insert for cervical ripening in obese women at term. Nevertheless, neonatal morbidity was significantly associated with the dinoprostone vaginal insert, compared with the CRB, among obese women who required cervical ripening at term.

Neurodevelopmental Outcome at Corrected Age of 2 Years among Children Born Preterm with Operative Vaginal Delivery: A Population-Based Study (LIFT Cohort).

The aim of the study was to determine whether operative vaginal delivery (OVD) was associated with non-optimal neurocognitive development at the corrected age of 2 years for preterm singletons using the Loire Infant Follow-up Team (LIFT) longitudinal cohort, a French regional perinatal network and prospective, population-based cohort of preterm infants. For this study, we included women with cephalic singletons and planned vaginal delivery from 24 to 34 weeks' gestation between 2006 and 2016. The main exposure was the mode of delivery (spontaneous vaginal delivery (SVD), OVD, and cesarean delivery (CS) during labor). The primary outcome was non-optimal neurodevelopmental outcome at the corrected age of 2 years assessed by a physical examination, a neuropsychological test, and/or a parental questionnaire. Secondary outcomes were survival at discharge and survival at discharge without morbidity. We used the multivariate logistic regression and propensity score methods to compare outcomes associated with OVD. The study included 1934 infants born preterm: 1384 (71.6%) with SVD, 87 (4.5%) with OVD, and 463 (23.9%) with CS. Neonates with SVD, OVD, and CS did not differ in survival (97.0%, 97.7%, and 97.8%, respectively; p = 0.79) or in survival without morbidity (82.8%, 86.2%, and 82.7%, respectively; p = 0.71). In survived infants, 1578 (81.6%) were evaluated at age two: 279 (17.7%) were considered to have a non-optimal neurodevelopmental outcome (18.3% after SVD, 18.0% after OVD, and 15.9% after CS; p = 0.57). Propensity score analysis showed that OVD was not associated with non-optimal neurocognitive development at age two, with an adjusted odds ratio (aOR) of 0.86 and a 95% confidence interval (95% CI) of 0.47-1.69, compared with SVD; and an aOR of 0.76 and a 95% CI of 0.31-1.8, compared with CS. Operative vaginal delivery was not associated with non-optimal neurocognitive development at 2 years of corrected age for preterm singletons.

Predictors of shoulder dystocia at the time of operative vaginal delivery: a prospective cohort study.

Our aim was to identify factors associated with shoulder dystocia following an attempted operative vaginal delivery (aOVD) in a prospective cohort study and to evaluate whether these factors can be used to accurately predict shoulder dystocia by building a score of shoulder dystocia risk. This was a planned secondary analysis of a prospective cohort study of deliveries with aOVD at term from 2008-2013. Cases were defined as women with shoulder dystocia following an aOVD defined as a delivery that requires additional obstetric maneuvers following failure of gentle downward traction on the fetal head to effect delivery of the shoulders. Multivariate logistic regression analyses were performed to determine risk factors for shoulder dystocia. Shoulder dystocia occurred in 57 (2.7%) of the 2118 women included. In the whole cohort, women with shoulder dystocia more often had a history of shoulder dystocia (3.5% vs. 0.2%, p = 0.01), and there was a significant interaction between aOVD and gestational age and the duration of the second stage of labor: women with shoulder dystocia more often had a gestational age > 40 weeks and a second stage of labor longer than 3 h specifically for midpelvic aOVD. In multivariable analysis, a history of shoulder dystocia was the only factor independently associated with shoulder dystocia following aOVD (aOR 27.00, 95% CI 4.10-178.00). The AUC for the receiver operating characteristic curve generated using a multivariate model with term interaction with head station was 0.70 (95% CI 0.62-0.77). The model failed to accurately predict shoulder dystocia.

Predictors of efficacy for cervical ripening among the Bishop score criteria in nulliparous women at term.

OBJECTIVE: To determine predictors of efficacy for cervical ripening among the Bishop score criteria in nulliparous women at term. METHOD: Prospective observational study of nulliparous women with singleton term fetuses in vertex presentation, intact membranes, and an unfavorable cervix (Bishop score < 6) who underwent cervical ripening with a cervical-ripening balloon (CRB; n = 47) or dinoprostone vaginal insert (PG; n = 28). The authors analyzed Bishop score criteria (dilatation, effacement, fetal station, consistency, position) before and after device removal. Primary outcome was favorable cervix (Bishop score ≥ 6) after device removal. Secondary outcomes were vaginal delivery, modification of Bishop score criteria, and perinatal morbidity. RESULTS: Rates of favorable cervix after cervical ripening were similar between groups (66.7% with CRB vs. 59.3% with PG; P = 0.526). Vaginal delivery (76.6% vs. 78.6%; P = 0.843) and perinatal morbidity did not differ between groups. CRB appeared to be more effective than PG in increasing consistency (+0.7 ± 0.2 vs. +0.3 ± 0.2; P = 0.001) and dilatation of the cervix (+1.3 ± 0.3 vs. +0.9 ± 0.3; P = 0.005). No Bishop score criterion was found as a significant predictor for vaginal delivery. CONCLUSION: CRB seems to be more effective than PG in increasing the consistency and dilatation of the cervix. Efficacy of CRB and PG for vaginal delivery was similar.

Predictive Factors for Successful Cervical Ripening among Women with Gestational Diabetes Mellitus at Term: A Prospective Study.

The purpose of this prospective cohort study is to identify the predictive factors for vaginal delivery among women (n = 146) who underwent cervical ripening using a dinoprostone insert (PG) alone (13.7%), cervical ripening balloon (CRB) alone (52.7%), oral misoprostol (M) alone (4.1%), or repeated methods (R, 29.5%) for gestational diabetes mellitus (GDM) at term, and to analyze maternal and neonatal morbidity outcomes according to the method for cervical ripening. After cervical ripening, vaginal delivery occurred in 84.2% (n = 123) and was similar among groups (90.0% after PG, 83.1% after CRB, 83.3% after M, and 83.7% after R; p = 0.89). After a multivariable logistic regression analysis adjusted for potential confounders, the internal cervical os being open before cervical ripening was a predictor of vaginal delivery (adjusted odds ratio (OR) of 4.38, 95% confidence index (CI) of 1.62-13.3, p = 0.03), and previous cesarean delivery was a predictor of cesarean delivery (aOR of 7.67, 95% CI of 2.49-24.00, p < 0.01). Birthweight was also significantly associated with cesarean delivery (aOR of 1.15, 95% CI of 1.03-1.31, p = 0.02). The rates of maternal and neonatal morbidity outcomes were 10.9% (n = 16) and 19.9% (n = 29), respectively, and did not differ according to the mode of delivery and to the method used for cervical ripening. Identifying these specific high-risk women (previous cesarean delivery and internal cervical os being closed before cervical ripening) for cesarean delivery among women who underwent cervical ripening for GDM at term is important and practical for all physicians to make a decision in partnership with women.

Neonatal Morbidity after Cervical Ripening with a Singleton Fetus in a Breech Presentation at Term.

Vaginal delivery in women with a breech presentation is part of common practice in France despite much debate, and the induction of labor (IOL) with a fetus in a breech presentation at term remains uncommon. Little is known about the effectiveness of cervical ripening and its neonatal and maternal safety in these women. We present a retrospective study of 362 women who gave birth to a live singleton fetus in a breech presentation at term. The objective was to compare severe maternal and neonatal morbidity according to the planned mode of labor (spontaneous labor or the induction of labor (IOL) with a favorable cervix, cervical ripening, or elective cesarean delivery) and, specifically, to compare cervical ripening to the other modes of labor. The rate of severe neonatal morbidity was 3.0% and was significantly higher after the IOL compared to elective cesarean delivery (p = 0.02), and the severe maternal morbidity rates were similar. Multivariable logistic regression analysis found no significant association between cervical ripening and either composite severe neonatal (adjusted odds ratio [aOR] 2.80, 95% confidence interval [CI] 0.10-43.6) or maternal morbidity (aOR 1.29, 95% CI 0.05-11.5). Our results support a policy of offering cervical ripening to the appropriately selected candidates with a singleton fetus in a breech presentation at term without increasing the incidence of severe maternal and neonatal morbidity.

Ropivacaine perineal infiltration for postpartum pain management in episiotomy repair: a double-blind, randomised, placebo-controlled trial.

OBJECTIVE: To investigate whether perineal infiltration of ropivacaine after episiotomy would decrease the incidence of postpartum pain compared with placebo. DESIGN: Two-centre, double-blind, randomised, controlled trial. SETTING: Two French maternity units, October 2017 to April 2020. POPULATION: 272 women undergoing epidural analgesia with vaginal singleton delivery and mediolateral episiotomy at term (≥37 weeks) were randomly allocated perineal infiltration of ropivacaine (n = 135) or placebo (n = 137) in a 1:1 ratio before episiotomy repair. METHODS: Patients were followed at short term (12, 24, 48 h), mid-term (day 7) and long-term (3 and 6 months). MAIN OUTCOME MEASURES: The primary outcome was the rate of perineal pain, defined by a Numerical Pain Rating Scale (NPRS) exceeding 3/10, in the mid-term (day 7) postpartum period. Secondary outcomes were perineal pain (NPRS) and analgesic intake, quality of life (SF-36), postpartum depression (EPDS), pain neuropathic component (DN4) and sexual health (FSFI). RESULTS: Perineal pain occurred to an equal extent in the ropivacaine and placebo groups at day 7 (34.2% versus 30.4%, odds ratio 1.1, 95% confidence interval 0.7-1.8, p = 0.63). Similar results were recorded in the short and long term. High rates of dyspareunia and postpartum depression were documented in both groups. No differences were highlighted between the groups in terms of analgesic intake, adverse events, pain neuropathic component and postpartum quality of life. CONCLUSIONS: This study did not demonstrate any benefit of ropivacaine infiltration over placebo.

Prospective observational study investigating the effectiveness, safety, women's experiences and quality of life at 3 months regarding cervical ripening methods for induction of labor at term-The MATUCOL study protocol.

BACKGROUND: The purposes of successful induction of labor (IOL) are to shorten the time for IOL to delivery, increase the vaginal delivery rate, and reduce the rate of maternal and neonatal morbidity. In cases of unfavorable cervix (Bishop score <6), cervical ripening is advised to improve vaginal delivery rate. It may be initiated by mechanical (double balloon catheter (DBC), synthetic osmotic dilator) or pharmacologic (prostaglandins) methods, and the problem is complex due to the multitude of cervical ripening methods. We are constantly looking for the optimal protocol of cervical ripening for each woman. The present study aims to elucidate whether cervical ripening method is associated with increase rate of vaginal delivery, good women's experience and unaltered long-term quality of life after cervical ripening at term regarding maternal and obstetric characteristics. METHODS AND DESIGN: The MATUCOL study is a monocentric, prospective, observational study of all consecutive women who required cervical ripening (Bishop score <6) using different methods (DBC, vaginal dinoprostone, oral misoprostol) with a live fetus at term (≥37 weeks) between January 2020 and August 2021. The outcomes will be mode of delivery, maternal and neonatal morbidity, discomfort/pain assessments during cervical ripening, women's experience and satisfaction, and the impact of cervical ripening on the health-related quality of life at 3 months. If it reports a significant efficacy/safety/perinatal morbidity/women's satisfaction/quality of life at 3 months post-delivery associated with a method of cervical ripening in a specific situation (gestational and/or fetal disease) using a multivariate analysis, its use should be reconsidered in clinical practice. DISCUSSION: This study will reveal that some cervical ripening methods will be more effectiveness, safe, with good women's experiences and QOL at 3 months compared to others regarding maternal and obstetric characteristics. TRIAL REGISTRATION: This study is being performed at La Roche sur Yon Hospital following registration as GNEDS on January 8, 2020.

Preterm Birth and Small-for-Gestational Age Neonates among Prepregnancy Underweight Women: A Case-Controlled Study.

The aim of our study was to investigate whether prepregnancy underweight body mass index (BMI) is associated with preterm birth (PTB) and small-for-gestational age (SGA). This retrospective case-control study included 814 women with live singleton fetuses in vertex presentation that gave birth between January 2016 and November 2016 in two tertiary care hospitals. The study group (n = 407) comprised all women whose prepregnancy BMI was underweight (<18.5 kg/m2) and who delivered during the study period. A control group (n = 407) was established with women whose prepregnancy BMI was normal (18.5-24.9 kg/m2) by matching age and parity. Univariate and multivariate analyses were performed to compare PTB and SGA associated with prepregnancy underweight BMI. Compared with the control group, the study group had higher rates of overall PTB (10.1% vs. 5.7%, p = 0.02), iatrogenic PTB (4.2% vs. 1.5%, p = 0.02), and SGA (22.1% vs. 11.1%, p < 0.001). In a multivariable analysis, prepregnancy underweight BMI was associated with PTB (aOR 2.32, 95% CI 1.12-4.81) and with SGA (aOR 2.38, 95% CI 1.58-3.58). In singleton pregnancies, women's prepregnancy underweight compared with normal BMI was associated with an increase in PTB and in SGA neonates. Identifying this specific high-risk group is pragmatic and practical for all physicians, and they should be aware about perinatal outcome among underweight women.

Risk Factors for Carbetocin Failure after a Cesarean Section: Is Obesity One of Them?

Obese pregnant women have increased rates of fetal macrosomia, long labor, and cesarean sections, which lead to an increased risk of postpartum hemorrhage (PPH). Carbetocin is useful for the prevention of PPH after a cesarean section. Our study aimed to investigate predictors of carbetocin failure after a cesarean section, and specifically whether obesity is associated with carbetocin failure. We retrospectively analyzed all women who received carbetocin after a cesarean section. Carbetocin failure was defined as changes in hematocrit and hemoglobin, blood loss ≥ 1000 mL, and the need for an additional uterotonic agent or second-line therapies for persistent PPH. Univariate and multivariate analyses were performed to investigate predictors of carbetocin failure. The study included 600 women, with 131 (21.8%) obese women. Overall, 44 (7.3%) carbetocin failures were reported, and rates of obese women were similar between groups (carbetocin failure, 11.4% vs. 22.9%; p = 0.08). Previous PPH (p < 0.001), a cesarean section during labor (p = 0.01), cervical ripening (p = 0.02), and birthweight (p = 0.01) were significantly different between groups. In the multivariable logistic regression analysis adjusted for potential confounders, cervical ripening (adjusted odds ratio (OR) 2.23, 95% confidence interval (CI) 1.01-4.80), compared with spontaneous labor, was significantly associated with carbetocin failure. Obesity was not associated with carbetocin failure after cesarean sections.

HE4 in the Diagnostic Approach of Endometrial Cancer in Patients with Postmenopausal Bleeding, the METRODEC Protocol: Protocol for a Multicenter Prospective Study.

BACKGROUND: Endometrial cancer is the most common pelvic gynecological cancer in France. The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies. The treatment is very codified and consists of a surgical intervention for anatomopathological analysis. The latter is frequently reassuring. These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery. This study aims to explore the sensitivity of an innovative marker: Human Epididymis 4 (HE4) in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings. METHODS: This is a prospective multicenter diagnostic study with three centers involved. Inclusion criteria are any patient with post-menopausal bleeding who is to undergo hysteroscopy, endometrial biopsy, or endometrial resection. In accordance with the recommendations for the management of post-menopausal bleedings, the medical conduct consists of performing a clinical examination, an ultrasound and, in general, even in case of paraclinical examination reassuring, an anatomopathological analysis. This pathological analysis can be obtained in several ways: biopsy, hysteroscopy-curettage (which is the most frequently performed surgery), and hysterectomy. Our protocol consists of taking a blood sample from each woman who will undergo one of the interventions mentioned above. The dosage of HE4 and CA125 requires the withdrawal of an additional heparinized tube during the preoperative assessment usually performed. This research is therefore classified as non-interventional. The primary outcome is to evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer. The secondary outcomes are other parameters (specificity, VPP, VPN) of HE4, Evaluating the diagnostic capabilities of the CA125 marker alone and associated with HE4, as well as those of the REM and REM-B algorithms. We aim to include 100 patients over a period of one year in three centers. DISCUSSION: As of now, there is no biological marker used in routine practice in the diagnosis of endometrial cancer. The ultimate goal of HE4 in endometrial cancer is to avoid surgery for those who are identified as non-sick. This study is the precursor of others for use in routine practice, HE4 would represent a great help to diagnosis if our study demonstrates it as reliable in the management of these patients and avoid many unnecessary and risky surgeries.

A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA).

BACKGROUND: We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA). METHODS: A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman's history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as "not important". In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as "not important" or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study. RESULTS: Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women. CONCLUSION: We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery. TRIAL REGISTRATION: The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 ( NCT04446780 ).

Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial.

BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.

A Prospective Study of Association of Micronutrients Deficiencies during Pregnancy and Neonatal Outcome among Women after Bariatric Surgery.

Little is known about the association of micronutrients deficiencies during pregnancy and neonatal outcome among women after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). We present a prospective study of 87 consecutive women with a history of RYGB (n = 37) or SG (n = 50) who underwent complete and regular clinical and biological nutritional assessments during pregnancy. Data on maternal characteristics, biological nutritional parameters, antenatal management, and perinatal outcome were collected. The objective was to evaluate serum levels of micronutrients at the second trimester, and to assess the association between micronutrients deficiencies and neonatal outcome. After RYGB, maternal age (34.3 ± 4.9 vs. 31.1 ± 4.6 years; p = 0.003) and pregnancy timing after surgery (64.5 ± 47.0 vs. 38.1 ± 28.1 months; p = 0.002) were significantly higher, and pre-pregnancy BMI was significantly lower (29.8 ± 5.6 vs. 32.9 ± 7.1 kg/m2; p = 0.03). Maternal and neonatal outcomes were similar. Additional supplementations after blood tests were similar in groups. Zinc, selenium, vitamins A1, B1, B6, C, and E levels were not different depending on the type of surgery. Zinc deficiency (7/87) was significantly more frequent after RYGP (18.9% vs. 0%; p = 0.02) and selenium deficiency (15/87) was similar in groups (21.6% after RYGB and 14.0% after SG; p = 0.36). The mean birth weight was significantly lower in selenium deficiency cases (3137 ± 550 vs. 3535 ± 737 g; p = 0.04). Selenium deficiency was negatively correlated with birth weight (r = -0.23; p = 0.03) and with birth weight z-score (r = -0.26; p = 0.01), but not correlated after adjustment for the procedure. The levels of micronutrients surveillance along pregnancy in women with a history of bariatric surgery is necessary to decrease the risk of inadequate fetal growth in the patients.

Methods of detection and prevention of preterm labour and the PAMG-1 detection test: a review.

OBJECTIVES: Preterm labour is the leading cause of hospitalization during pregnancy. In France, it results in more than 60,000 births before 37 weeks of gestation every year. Recent studies suggest that detection of placental α-microglobulin-1 (PAMG-1) in vaginal secretions among women presenting symptoms of preterm labour with intact membranes has good predictive value for the onset of spontaneous preterm delivery within 7 days. The test is especially interesting, in that the repetition of antenatal corticosteroids for foetal lung maturation is no longer recommended in France and the effect of the initial administration is most beneficial in the 24 h to 7 days afterwards. METHODS: We included all studies listed in PubMed and clinicaltrials.gov with the terms "PAMG-1" and either "preterm labor" or "preterm labour", while excluding all studies on the subject of "rupture of the membranes" from 2000 through 2017. Ten studies were thus included. RESULTS: In women who had both the PAMG-1 and foetal fibronectin test, the PAMG-1 test was statistically superior to the measurement of cervical length for positive predictive value (p<0.0074), negative predictive value (p=0.0169) and specificity (p<0.001) for the prediction of spontaneous preterm delivery within 7 days. CONCLUSIONS: The use of PAMG-1 may make it possible to target the women at risk with a shortened cervix on ultrasound (<25 mm) those with an imminent preterm delivery and therefore to adapt management, especially the administration of antenatal corticosteroid therapy.

Subclinical hypothyroidism is not associated with neonatal morbidity in women with gestational diabetes mellitus: a case-control study.

PURPOSE: Placental modifications observed in women with subclinical hypothyroidism (SCH) should be associated with altered fetal development in women with gestational diabetes mellitus (GDM) and worsen perinatal outcome. We aim to determine if SCH is associated with neonatal morbidity in women with GDM. METHODS: A secondary analysis of data collected for a prospective population-based cohort study including all pregnant women with singleton pregnancies at diagnosis of GDM in a tertiary care university hospital. Thyroid-stimulating hormone and free thyroxine were measured at diagnosis of GDM. Perinatal outcome was compared between two groups-women with SCH and euthyroid. Neonatal morbidity was defined by at least one of the following criteria: preterm birth, macrosomia, shoulder dystocia, respiratory distress syndrome, 5-min Apgar score < 7, pH < 7.10, and admission to the NICU (neonatal intensive-care unit) for 24 h. RESULTS: Of the total 200 women enrolled, 150 were evaluable for the study. Of whom, 9 (6%) women presented SCH. The mean gestational age at diagnosis of GDM was 21.7 ± 7.0 weeks. Maternal outcome of women with SCH was similar to euthyroid women. Neonatal morbidity occurred in 17.3% (26/150). Women with SCH had higher rate of neonatal morbidity (44.4% vs. 15.6%; p = 0.03), specifically due to admission to the NICU for 24 h (33.3% vs. 5.7%; p = 0.02). SCH in women with GDM is not associated with neonatal morbidity after controlling for gestational age at birth and admission to NICU (adjusted OR 2.02, 95% CI 0.75-10.23). CONCLUSION: Subclinical hypothyroidism is not associated with neonatal morbidity in women with gestational diabetes mellitus.

The value of a vaginal sample for detecting PAMG-1 (Partosure®) in women with a threatened preterm delivery (the MAPOSURE Study): protocol for a multicenter prospective study.

BACKGROUND: Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD. METHODS: This is a prospective multicenter diagnostic study. Inclusion criteria are singleton pregnancy, gestational age between 24 + 0 and 33 + 6 weeks inclusive, cervical measurement 25 mm or less assessed by transvaginal ultrasound (with or without uterine contractions), clinically intact membranes and cervical dilatation < 3 cm assessed by digital examination. According to the current protocol, when a women presents with TPD and the diagnosis is confirmed by transvaginal ultrasound, a vaginal sample to test for genital infection is performed. At the same time, the midwife will perform the PartoSure® test. To perform this analysis, a sample of cervicovaginal secretions is taken with the vaginal swab furnished in the test kit. The primary outcome is the specificity of the PartoSure® test of women who gave birth more than 7 days after their hospitalization for TPD. The secondary outcomes are the sensitivity, PPV, and NPV of the Partosure® test and the factors associated with false positives (with a univariate logistic regression model). Starting with the hypothesis of an anticipated specificity of 89%, if we want to estimate this specificity with a confidence interval of ± 5%, we will require 151 women who do not give birth within 7 days. We therefore decided to include 400 women over a period of two years to have a larger number of events (deliveries within 7 days). DISCUSSION: The different tests already used such as fetal fibronectin and phIGFBP-1, are not sufficiently relevant to recommend their use in daily practice. The different studies of PAMG-1 described above thus provide support for the use of this substance, tested by PartoSure®. Nonetheless, other larger studies are necessary to validate its use in daily practice and our study could answer this question. TRIAL REGISTRATION: NCT03401255 (January 15, 2018).

Systematic Kleihauer-Betke Test after External Cephalic Version for Breech Presentation: Is It Useful?

The incidence of fetomaternal hemorrhage (FMH) after external cephalic version (ECV) has been poorly reported. In this study, we evaluated the frequency of FMH, diagnosed by positive Kleihauer-Betke test (KBT), after ECV attempt and then evaluate the relevance of its routine use after procedure. A total of 282 women with a term breech presentation and who had ECV attempt were recruited from January 2014 and December 2018. After ECV attempt, women were systematically screened for FMH using KBT. Data on ECV attempt, KBT results, perinatal and neonatal outcomes were collected and compared between women with positive (cases) and negative KBT (controls) after ECV. The success rate of ECV was 22.0% (62/282). Eight women (2.9%) experienced transient fetal heart rate (FHR) abnormalities after ECV. In five (1.8%) women, KBT was positive after ECV. Obstetrical management was modified for two of these five women due to continuous positivity of KBT at day 1 and day 7 controls after ECV attempt. A cesarean section was planned 7 days earlier due to persistent high FMH on day 7 (6 mL fetal blood) in one woman and the labor was induced for persistent high FMH on day 7 (20 mL fetal blood) for another woman. No newborns have signs of fetal anemia at birth and there was no significant difference in neonatal status between two groups. FMH after ECV attempt are rare, and no negative fetal or neonatal outcomes were observed when KBT was positive, even strongly (>5 mL fetal blood). It appears that systematic KBT after attempted ECV is probably not useful.

Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials.

BACKGROUND: Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy but have only focused on the immediate postpartum period (at 24 and 48 h after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. METHODS/DESIGN: The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial being conducted in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75 mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. DISCUSSION: Ropivacaine is a promising candidate drug, inexpensive, and easy to administer, and it would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03084549. Registered on 14 April 2017.

Correction to: Clinical Practice Guidelines for Childbearing Female Candidates for Bariatric Surgery, Pregnancy, and Post-Partum Management after Bariatric Surgery.

In the original article, due to an XML tagging error the name of Véronique Taillard was omitted from the list of members of the French Study Group for Bariatric Surgery and Maternity (the BARIA-MAT Group). The correct list is as follows.