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.

Re-evaluating fetal scalp pH thresholds: An examination of fetal pH variations during labor.

INTRODUCTION: Since the 1970s, fetal scalp blood sampling (FSBS) has been used as a second-line test of the acid-base status of the fetus to evaluate fetal well-being during labor. The commonly employed thresholds that delineate normal pH (>7.25), subnormal (7.20-7.25), and pathological pH (<7.20) guide clinical decisions. However, these experienced-based thresholds, based on observations and common sense, have yet to be confirmed. The aim of the study was to investigate if pH drop rate accelerates at the common thresholds (7.25 and 7.20) and to explore the possibility of identifying more accurate thresholds. MATERIAL AND METHODS: A retrospective study was conducted at a tertiary maternity hospital between June 2017 and July 2021. Patients with at least one FSBS during labor for category II fetal heart rate and delivery of a singleton cephalic infant were included. The rate of change in pH value between consecutive samples for each patient was calculated and plotted as a function of pH value. Linear regression models were used to model the evolution of the pH drop rate estimating slope and standard errors across predefined pH intervals. Exploration of alternative pH action thresholds was conducted. To explore the independence of the association between pH value and pH drop rate, multiple linear regression adjusted on age, body mass index, parity, oxytocin stimulation and suspected small for gestational age was performed. RESULTS: We included 2047 patients with at least one FSBS (total FSBS 3467); with 2047 umbilical cord blood pH, and a total of 5514 pH samples. Median pH values were 7.29 1 h before delivery, 7.26 30 min before delivery. The pH drop was slow between 7.40 and 7.30, then became more pronounced, with median rates of 0.0005 units/min at 7.25 and 0.0013 units/min at 7.20. Out of the alternative pH thresholds, 7.26 and 7.20 demonstrated the best alignment with our dataset. Multiple linear regression revealed that only pH value was significantly associated to the rate of pH change. CONCLUSIONS: Our study confirms the validity and reliability of current guideline thresholds for fetal scalp pH in category II fetal heart rate.

Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone: a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial.

BACKGROUND: Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, reports of growth and neurodevelopmental dose-related side-effects suggest that the current dose (12 mg plus 12 mg, 24 h apart) might be too high. We therefore investigated whether a half dose would be non-inferior to the current full dose for preventing respiratory distress syndrome. METHODS: We designed a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial in 37 level 3 referral perinatal centres in France. Eligible participants were pregnant women aged 18 years or older with a singleton fetus at risk of preterm delivery and already treated with the first injection of antenatal betamethasone (11·4 mg) before 32 weeks' gestation. We used a computer-generated code producing permuted blocks of varying sizes to randomly assign (1:1) women to receive either a placebo (half-dose group) or a second 11·4 mg betamethasone injection (full-dose group) 24 h later. Randomisation was stratified by gestational age (before or after 28 weeks). Participants, clinicians, and study staff were masked to the treatment allocation. The primary outcome was the need for exogenous intratracheal surfactant within 48 h after birth. Non-inferiority would be shown if the higher limit of the 95% CI for the between-group difference between the half-dose and full-dose groups in the primary endpoint was less than 4 percentage points (corresponding to a maximum relative risk of 1·20). Four interim analyses monitoring the primary and the secondary safety outcomes were done during the study period, using a sequential data analysis method that provided futility and non-inferiority stopping rules and checked for type I and II errors. Interim analyses were done in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT02897076. FINDINGS: Between Jan 2, 2017, and Oct 9, 2019, 3244 women were randomly assigned to the half-dose (n=1620 [49·9%]) or the full-dose group (n=1624 [50·1%]); 48 women withdrew consent, 30 fetuses were stillborn, 16 neonates were lost to follow-up, and 9 neonates died before evaluation, so that 3141 neonates remained for analysis. In the intention-to-treat analysis, the primary outcome occurred in 313 (20·0%) of 1567 neonates in the half-dose group and 276 (17·5%) of 1574 neonates in the full-dose group (risk difference 2·4%, 95% CI -0·3 to 5·2); thus non-inferiority was not shown. The per-protocol analysis also did not show non-inferiority (risk difference 2·2%, 95% CI -0·6 to 5·1). No between-group differences appeared in the rates of neonatal death, grade 3-4 intraventricular haemorrhage, stage ≥2 necrotising enterocolitis, severe retinopathy of prematurity, or bronchopulmonary dysplasia. INTERPRETATION: Because non-inferiority of the half-dose compared with the full-dose regimen was not shown, our results do not support practice changes towards antenatal betamethasone dose reduction. FUNDING: French Ministry of Health.

Contemporary duration of spontaneous labor and association with maternal characteristics: A French national population-based study.

BACKGROUND: The objective of this study was to describe labor duration of women managed with current obstetric practices in a French national population-based cohort and to assess the association of age and BMI on this duration. METHODS: All women in the French perinatal survey of 2016 with a singleton cephalic fetus, delivering at term after a spontaneous labor were included. Duration of labor was defined as time between admission to the labor ward and birth. Duration of total labor and first and second stage of labor were described. Then, duration of labor was estimated according to maternal age and BMI, using Kaplan-Meier's method and compared with the log-rank test after stratification on parity. Intrapartum cesarean birth was considered as a censoring event. Multivariable modeling was performed using Cox's proportional hazard's method. RESULTS: Data of 3120 nulliparous and 4385 multiparous women were analyzed. Median labor duration was 6.1 hours ([5th; 95th percentile]) [1.4; 12.6] and 3.1 hours [0.3; 8.5] in nulliparous and multiparous women. Multivariable Cox analysis showed no independent association of maternal age and duration of labor. Nulliparous obese women had significantly lower odds of having a shorter labor than women with a BMI < 25 kg/m2 , HR: 0.75; 95% CI [0.64-0.88], but BMI was not associated with labor duration in multiparous women. CONCLUSIONS: Our study provides important information for both women and care practitioners on what to expect when entering the labor ward. There appears to be little association between maternal characteristics and labor duration, with the exception of BMI in nulliparous women.

Reducing neonatal morbidity by discontinuing oxytocin during the active phase of first stage of labor: a multicenter randomized controlled trial STOPOXY.

BACKGROUND: Oxytocin is effective in reducing labor duration, but can be associated with fetal and maternal complications such as neonatal acidosis and post-partum hemorrhage. When comparing discontinuing oxytocin in the active phase with continuing oxytocin infusion, previous studies were underpowered to show a reduction in neonatal morbidity. Thus, we aim at evaluating the impact of discontinuing oxytocin during the active phase of the first stage of labor on the neonatal morbidity rate. METHODS: STOPOXY is a multicenter, randomized, open-label, controlled trial conducted in 20 maternity units in France. The first participant was recruited January 17th 2020. The trial includes women with a live term (≥37 weeks) singleton, in cephalic presentation, receiving oxytocin before 4 cm, after an induced or spontaneous labor. Women aged < 18 years, with a lack of social security coverage, a scarred uterus, a multiple pregnancy, a fetal congenital malformation, a growth retardation <3rd percentile or an abnormal fetal heart rate at randomization are excluded. Women are randomized before 6 cm when oxytocin is either continued or discontinued. Randomization is stratified by center and parity. The primary outcome, neonatal morbidity is assessed using a composite variable defined by an umbilical arterial pH at birth < 7.10 and/or a base excess > 10 mmol/L and/or umbilical arterial lactates> 7 mmol/L and/or a 5 min Apgar score < 7 and/or admission in neonatal intensive care unit. The primary outcome will be compared between the two groups using a chi-square test with a p-value of 0.05. Secondary outcomes include neonatal complications, duration of active phase, mode of delivery, fetal and maternal complications during labor and delivery, including cesarean delivery rate and postpartum hemorrhage, and birth experience. We aim at including 2475 women based on a reduction in neonatal morbidity from 8% in the control group to 5% in the experimental group, with a power of 80% and an alpha risk of 5%. DISCUSSION: Discontinuing oxytocin during the active phase of labor could improve both child health, by reducing moderate to severe neonatal morbidity, and maternal health by reducing cesarean delivery and postpartum hemorrhage rates. TRIAL REGISTRATION: Clinical trials NCT03991091 , registered June 19th, 2019.

Impact of history of myomectomy on preterm birth risk in women with a leiomyomatous uterus: a propensity score analysis.

BACKGROUND: To evaluate if women with a history of myomectomy have a modified preterm birth risk compared to women with myomas during pregnancy. METHODS: Retrospective cohort study including all women with a history of myomectomy (operated group) or uterine myomas during pregnancy (unoperated group) who delivered in a tertiary center between January, 2011 and December, 2017. The operated group included women who had a myomectomy history with or without myomas during the ongoing pregnancy. The unoperated group included women with uterine myoma(s) seen on at least one ultrasound during pregnancy without history of myomectomy. The primary outcome was preterm birth < 37 weeks, and the secondary outcome spontaneous preterm birth < 37 weeks. To control for confounding factors, a propensity score approach was used. Two sensitivity analysis were performed, one repeating the analysis using the propensity score after excluding operated women with persistent myomas and one using a classical multivariable logistic regression model. RESULTS: The cohort included 576 women: 283 operated women and 293 unoperated women. The rate of preterm birth was similar in the two groups: 12.6% in the unoperated group and 12.0% in the operated group (p = 0.82). No difference in preterm birth risk was shown between unoperated and operated women in the cohort matched on the propensity score: OR 0.86; 95%CI [0.47-1.59]. These results were consistent for spontaneous preterm birth (OR 1.61; 95%CI [0.61-4.23]) and for the sensitivity analyses. CONCLUSION: In women with a leiomyomatous uterus, a history of myomectomy is not associated with a reduced preterm birth risk.

Is induction of labor a reasonable option for breech presentation?

INTRODUCTION: Whereas spontaneous onset of labor and vaginal delivery for breech presentation is considered to be a safe and effective option in selected cases, the safety of induction of labor is not established yet. The objectives of this study were to describe the outcomes of pregnancy in women induced with a fetus in breech presentation and compare the outcomes with those undergoing planned cesarean delivery. MATERIAL AND METHODS: We performed a secondary analysis of the observational prospective multicenter PREMODA study, including all singleton breech deliveries after 37 weeks in 174 centers in France and Belgium. We excluded women with spontaneous onset of labor, scarred uterus or intrauterine fetal death. Our study population consisted of women with either induction of labor or planned cesarean delivery. The primary outcome was the composite criteria of neonatal mortality and serious morbidity used in the Term Breech Trial and in the PREMODA prospective cohort. RESULTS: Our study population consisted of 4138 women, 218 with induction of labor and 3920 with planned cesarean. Two-thirds (67.4%) of the women in the induction of labor group delivered vaginally. There was no significant difference between the groups for the primary outcome (48 [1.2%] in the planned cesarean group vs 3 [1.4%] in the induction of labor group, P = 0.75). Moreover, none of the criteria of the composite primary outcome was significantly more frequent in the induction of labor group. CONCLUSIONS: Induction of labor for breech presentation does not seem to increase neonatal mortality or severe neonatal morbidity compared with planned cesarean delivery.

Leiomyomatous uterus and preterm birth: an exposed/unexposed monocentric cohort study.

BACKGROUND: The risk of preterm birth may increase in the presence of uterine leiomyomas during pregnancy. Whether myomectomy abrogates this risk has never been studied. OBJECTIVE: Our aim was to evaluate the association between the presence of uterine leiomyomas during pregnancy and preterm birth and, if an association exists, to evaluate its persistence in case of a history of myomectomy. STUDY DESIGN: This exposed/unexposed monocentric retrospective cohort study included all women with singleton pregnancies delivering >22 weeks in a tertiary university hospital maternity unit from January 2011 through September 2015. Women with a leiomyomatous uterus were compared to women with no myomas. Women in the leiomyomatous uterus group were women with uterine leiomyoma(s) during pregnancy (≥1 leiomyoma, measuring ≥20 mm or multiple leiomyomas whatever the size) seen on at least 1 obstetric ultrasound without history of myomectomy, or women with a history of myomectomy (removal of ≥1 leiomyoma, measuring ≥20 mm or multiple leiomyomas whatever the size) by hysteroscopy, laparoscopy, or laparotomy with or without persistent leiomyomas. The association between leiomyomatous uterus and preterm birth was assessed through univariate and multivariable logistic regression. RESULTS: Among the 19,866 women in the cohort, 301 (1.5%) had a leiomyomatous uterus (154 unoperated women and 147 operated women). The rate of premature delivery was 12.0% in the leiomyomatous uterus group and 8.4% in the nonleiomyomatous uterus group. After adjusting for the risk factors for preterm birth, leiomyomatous uterus was significantly associated with preterm birth (adjusted odds ratio, 2.5; 95% confidence interval, 1.7-3.7). This association was significant for unoperated women (adjusted odds ratio, 2.7; 95% confidence interval, 1.6-4.6) as well as operated women (adjusted odds ratio, 2.3; 95% confidence interval, 1.3-3.9) when compared to the nonleiomyomatous uterus group. CONCLUSION: Uterine leiomyomas are associated with preterm birth and this association persists after myomectomy.

Asymptomatic short cervix and threatened preterm labor: A comparative study on perinatal outcomes.

OBJECTIVE: To determine the rate of delivery within 15 days of admission among patients with an asymptomatic short cervix (ASC) compared to those admitted for threatened preterm labor (TPL). MATERIAL AND METHODS: This retrospective study conducted in a tertiary maternity hospital, included patients with a singleton pregnancy admitted with a cervical length of less than 25 mm between 24 and 34 weeks. The population was divided into two groups, patients with ASC (i.e., with no contractions at admission) and patients with TPL. The primary outcome was the delivery rate within 15 days of admission. Secondary outcomes included gestational age at delivery, preterm delivery rate before 37°/7 weeks and before 34°/7 weeks, admission to delivery interval, 5 min Apgar score and transfer to neonatal intensive care unit rate. The characteristics of the two groups and the primary and secondary outcomes were compared between the two groups using univariate analysis. Two subgroup analysis were performed, one restricted to patients with a mildly modified CL (15 ≤ CL < 25 mm), and one excluding patients at high risk of preterm birth. RESULTS: Among the 247 included patients, 136 (55.1 %) had TPL, and 111 (44.9 %) ASC. There were no significant differences in the rate of patient who delivered within 15 days of admission between the groups, 13.2 % in the TPL group vs 8.0 % in the ASC group (p = 0.22). Patients in the TPL group had a significantly higher frequency of delivery before 34 weeks compared to those in the ASC group (19.9 % versus 9.0 %, p = 0.02 This finding persisted in the subgroup analysis excluding patients at high risk of preterm birth (16.5 % in the TPL subgroup vs. 6.9 % in the ASC subgroup, p = 0.04). There were no significant differences in the rates of preterm delivery before 37 weeks, the admission-to-delivery interval, or neonatal outcomes between the two groups or within the subgroup analyses. CONCLUSION: The frequency of delivery within 15 days of admission was not statistically different between patients with an asymptomatic short cervix and those with TPL. Nevertheless, these asymptomatic patients delivered significantly later and less frequently before 34 weeks, with only one in ten requiring corticosteroids.

Assessing the external validity and clinical relevance of umbilical doppler resistance index references in daily practice.

OBJECTIVE: To assess the external validity and clinical relevance of current references for umbilical artery resistance index (UA RI) in daily practice. METHODS: Retrospective cross-sectional single center study including all UA RI measurements between 22 and 40 gestational weeks (GW) from distinct patients between 2014 and 2022. Patients with normal pregnancies and normal neonatal outcomes that had an UA RI measurement between 2014 and 2019 were used to calculate reference ranges. The established reference for the 95th centile was compared to two current references. The clinical relevance of the established reference was tested by comparing neonatal outcomes according to the 95th percentile among the consecutive distinct patients between 2020 and 2022. RESULTS: Among the 13342 consecutive distinct patients with a singleton pregnancy that had an UA RI measurement between 22 and 40 GW between 2014 and 2022, 5298 patients were included to establish the reference ranges, and 3634 patients to validate these ranges. For each gestational age, the established references were similar to current references. Using the established references, the proportion of patients presenting an UA RI>95th percentile among the patients with normal pregnancies in the validation population was comparable to the proportion when using the two current references. Among the validation population, 268 patients (7.4 %) (95%CI[6.5-8.2]) presented an UA RI ≥ 95th percentile. Of these 268 patients, 67.9% had a SGA newborn (versus 19.2%, p<0.001) and 59% a preterm birth (versus 13.9%, p<0.001). CONCLUSIONS: The reference range obtained from daily practice is clinically relevant and similar to current references.

Patient experience in prostaglandins-induced cervical ripening: A comparative study using a standardized questionnaire.

OBJECTIVE: Cervical ripening for induction of labor is often associated with negative patient experience. The debate over the most effective cervical ripening method persist, with a significant gap in research specifically addressing patient satisfaction. Our study aims to compare patient experience with two induction methods, slow-release intravaginal dinoprostone device and orally administered misoprostol. METHOD: We conducted a before-and-after comparative study at a university tertiary hospital, including all patients undergoing cervical ripening with a Bishop score of 3 or lower. Our study compared two separate two-month periods, where the methods for cervical ripening differed. The first period employed an intravaginal dinoprostone slow-release device, while the second period used oral misoprostol. The primary outcome was patient experience, assessed using the EXIT questionnaire, a standardized and validated self-reported measure. Secondary outcomes were efficacy and safety outcomes. RESULTS: A total of 165 patients were included, 81 induced with dinoprostone and 84 induced with misoprostol. The EXIT questionnaire completion rate was 67.9 % (n = 55) in the dinoprostone group and 76.1 % (n = 64) in the misoprostol group (p = 0.23). Patients induced with misoprostol reported higher levels of satisfaction compared to those induced with dinoprostone, which can be attributed to reduced discomfort associated with the induction process (mean satisfaction score 2.26 ± 0.98 versus 2.80 ± 0.85 on a 1 to 5 likert-scale, p-value < 0.01). Adverse effects were reported less frequently with misoprostol compared to dinoprostone (20.2 % vs 48.1 %, p-value < 0.01). Time between cervical ripening and delivery was shorter in the misoprostol group (27.0 ± 10.2 h vs 32.5 ± 10.0, p < 0.01). There were no difference in mode of delivery or other obstetrical and neonatal outcomes. CONCLUSION: For women undergoing cervical ripening, oral misoprostol appears to be a less invasive method for labor induction, associated with higher levels of satisfaction and reduced discomfort compared to the intravaginal dinoprostone slow-release device.

Passive second stage of labor: Does a fourth hour increase maternal morbidity in nulliparous patients at term with epidural?

OBJECTIVES: Prolonging the passive second stage of labor could increase vaginal birth rate, but the data concerning maternal and fetal morbidity are contradictory. The French guidelines did not specify a maximum duration of the passive second stage. Our objective was to assess if allowing a 4th hour after full dilatation before pushing increased maternal morbidity, compared to 3 h after full dilatation. STUDY DESIGN: This single-center, retrospective, observational cohort study took place from January 1-December 31, 2020, in a tertiary maternity unit. All consecutive term nulliparous women who delivered under epidural anesthesia and without pathological fetal heart rate and reaching a second-stage passive phase of labor lasting at least 3 h were included. We compared 2 groups according to the duration of the passive second stage: "3-hour group" and "4-hour group". In the "3-hour group," featuring a second-stage passive phase of up to 3 h, pushing is initiated for favorable conditions, while a cesarean section is performed if conditions are deemed unfavorable. In the "4-hour group", obstetric conditions not justifying immediate pushing after three hours, and the obstetric team believed that an additional hour of expectant management could lead to a successful vaginal delivery. The principal endpoint was a composite criterion of maternal morbidity including obstetric anal sphincter injuries, postpartum hemorrhage, transfusion and intrauterine infection. RESULTS: We included 111 patients in the "4-hour group" and 349 in the "3-hour group". Composite maternal morbidity did not increase in the "4-hour group" compared to the "3-hour group" (21 (18.9 %) versus 61 (17.5 %); p = 0.73). Neonatal morbidity was similar between the two groups. In the "4-hour group, 91 (82 %) patients had vaginal deliveries", 62 (55,9 %) by spontaneous vaginal delivery and 29 (26,1 %) with instrumental assistance. CONCLUSION: For selected patients, waiting for 4 h at full dilation can be beneficial due to the high rate of vaginal delivery and low incidence of maternal and fetal complications.

[Fetal death: Expert consensus from the College of French Gynecologists and Obstetricians]. / Mort fœtale : consensus formalisé d'experts du Collège national des gynécologues-obstétriciens français.

Fetal death is defined as the spontaneous cessation of cardiac activity after fourteen weeks of amenorrhea. In France, the prevalence of fetal death after 22 weeks is between 3.2 and 4.4/1000 births. Regarding the prevention of fetal death in the general population, it is not recommended to counsel for rest and not to prescribe vitamin A, vitamin D nor micronutrient supplementation for the sole purpose of reducing the risk of fetal death (Weak recommendations; Low quality of evidence). It is not recommended to prescribe aspirin (Weak recommendation; Very low quality of evidence). It is recommended to offer vaccination against influenza in epidemic periods and against SARS-CoV-2 (Strong recommendations; Low quality of evidence). It is not recommended to systematically look for nuchal cord encirclements during prenatal screening ultrasounds (Strong Recommendation; Low Quality of Evidence) and not to perform systematic antepartum monitoring by cardiotocography (Weak Recommendation; Very Low Quality of Evidence). It is not recommended to ask women to perform an active fetal movement count to reduce the risk of fetal death (Strong Recommendation; High Quality of Evidence). Regarding evaluation in the event of fetal death, it is suggested that an external fetal examination be systematically offered (Expert opinion). It is recommended that a fetopathological and anatomopathological examination of the placenta be carried out to participate in cause identification (Strong Recommendation. Moderate quality of evidence). It is recommended that chromosomal analysis by microarray testing be performed rather than conventional karyotype, in order to be able to identify a potentially causal anomaly more frequently (Strong Recommendation, moderate quality of evidence); to this end, it is suggested that postnatal sampling of the placental fetal surface for genetic purposes be preferred (Expert Opinion). It is suggested to test for antiphospholipid antibodies and systematically perform a Kleihauer test and a test for irregular agglutinins (Expert opinion). It is suggested to offer a summary consultation, with the aim of assessing the physical and psychological status of the parents, reporting the results, discussing the cause and providing information on monitoring for a subsequent pregnancy (Expert opinion). Regarding announcement and support, it is suggested to announce fetal death without ambiguity, using simple words and adapting to each situation, and then to support couples with empathy in the various stages of their care (Expert opinion). Regarding management, it is suggested that, in the absence of a situation at risk of disseminated intravascular coagulation or maternal vitality, the patient's wishes should be taken into account when determining the time between the diagnosis of fetal death and induction of birth. Returning home is possible if it's the patient wish (Expert opinion). In all situations excluding maternal life-threatening emergencies, the preferred mode of delivery is vaginal delivery, regardless the history of cesarean section(s) history (Expert opinion). In the event of fetal death, it is recommended that mifepristone 200mg be prescribed at least 24hours before induction, to reduce the delay between induction and delivery (Low recommendation. Low quality of evidence). There are insufficient data in the literature to make a recommendation regarding the route of administration (vaginal or oral) of misoprostol, neither the type of prostaglandin to reduce induction-delivery time or maternal morbidity. It is suggested that perimedullary analgesia be introduced at the start of induction if the patient asks, regardless of gestational age. It is suggested to prescribe cabergoline immediately in the postpartum period in order to avoid lactation, whatever the gestational age, after discussing the side effects of the treatment with the patient (Expert opinion). The risk of recurrence of fetal death after unexplained fetal death does not appear to be increased in subsequent pregnancies, and data from the literature are insufficient to make a recommendation on the prescription of aspirin. In the event of a history of fetal death due to vascular issues, low-dose aspirin is recommended to reduce perinatal morbidity, and should not be combined with heparin therapy (Low recommendation, very low quality of evidence). It is suggested not to recommend an optimal delay before initiating another pregnancy just because of the history of fetal death. It is suggested that the woman and co-parent be informed of the possibility of psychological support. Fetal heart rate monitoring is not indicated solely because of a history of fetal death. It is suggested that delivery not be systematically induced. However, induction can be considered depending on the context and parental request. The gestational age will be discussed, taking into account the benefits and risks, especially before 39 weeks. If a cause of fetal death is identified, management will be adapted on a case-by-case basis (expert opinion). In the event of fetal death occurring in a twin pregnancy, it is suggested that the surviving twin be evaluated as soon as the diagnosis of fetal death is made. In the case of dichorionic pregnancy, it is suggested to offer ultrasound monitoring on a monthly basis. It is suggested not to deliver prematurely following fetal death of a twin. If fetal death occurs in a monochorionic twin pregnancy, it is suggested to contact the referral competence center, in order to urgently look for signs of acute fetal anemia on ultrasound in the surviving twin, and to carry out weekly ultrasound monitoring for the first month. It is suggested not to induce birth immediately.

Implementation of glucose 5% supplementation protocol to reduce the duration of labor among women with cervical ripening by prostaglandins: The GLUCOSHORT before-and-after study.

INTRODUCTION: Previous publications have shown that glucose supplementation could reduce labor duration in women with induction of labor with a favorable cervix but none have shown it for women with an unfavorable cervix.  The purpose of our study was to assess the impact on labor duration of a protocol of glucose supplementation used for induction of labor in women with an unfavorable cervix. MATERIAL AND METHODS: The protocol implemented in November 2017 added glucose supplementation by 5% dextrose at 125 mL/h to Ringer lactate for women with an unfavorable cervix with labor induced with dinoprostone gel. The study included women who underwent this protocol with a singleton, term, cephalic fetus from June 2017 through April 2018. The primary outcome was the labor duration. The secondary outcomes were mode of delivery, postpartum hemorrhage rate, neonatal outcomes, and durations other stage of labor. These outcomes were compared between the pre-intervention (from June 1 to October 31, 2017) and post-intervention (from December 1, 2017 to April 30, 2018) periods. RESULTS: The pre-intervention period included 116 women, and the post-intervention period 123. The characteristics of women and the induction of labor were similar in the two periods. The median duration from induction to delivery was not significantly different between the two periods (13.2 h, IQR 9.1-18.6 versus 13.6 h IQR 9.3-18.3, P=.67). The secondary outcomes did not differ significantly between the two groups. DISCUSSION: Glucose supplementation administered to women with an unfavorable cervix undergoing induction does not appear to reduce the induction-delivery duration.

Failed induction of labor in term nulliparous women with an unfavorable cervix: Comparison of cervical ripening by two forms of vaginal prostaglandins (slow-release pessary and vaginal gel).

OBJECTIVE: To compare the rate of failed induction after cervical ripening by two forms of vaginal prostaglandins. MATERIAL AND METHODS: This two-year retrospective study (January 1, 2016, through December 31, 2017) in two tertiary maternity units included nulliparous women with a singleton fetus in cephalic presentation and an unfavorable cervix requiring labor induction for prolonged pregnancy. The principal endpoint was the rate of failed induction, defined by the performance of a cesarean delivery before 6 cm of dilation. Cervical ripening was initiated by prostaglandins for 24 h, using a slow-release pessary (unit A) or a vaginal gel (unit B). The care protocol of the two groups after the first 24 h were similar. The women's individual characteristics were compared between the two units. The rates of failed induction were then compared between the two units, first by univariate and then by multivariable analysis adjusted for the characteristics that differed significantly between the units. RESULTS: Among the 17,217 women delivered in the two maternity units during the study period, 178 met our inclusion criteria (125 in unit A (slow-release pessary) and 53 in unit B (vaginal gel)). The rate of failed induction was similar: 21.6% in unit A (slow-release pessary) and 17.0% in unit B (vaginal gel) (P = 0.48). The multivariate analysis did not show any difference about failed induction, time from the onset of induction to delivery, and vaginal delivery rate within 24h. CONCLUSION: The rate of failed induction of labor did not differ between slow-release pessary and vaginal gel.

Publication rate and factors associated with publication of research projects by obstetrics residents in an academic department over 10 years.

OBJECTIVES: To determine the publication rate of mandatory research projects conducted by obstetrics residents and to evaluate the publication-associated factors and reported obstacles. STUDY DESIGN: This retrospective cohort study included all consecutive residents in an academic obstetrics-gynecology department in Paris, France, between 2010 and 2020. All residents were required to conduct a research project. Information about publication was collected by searching PubMed. A closed-ended questions questionnaire was sent to former residents about their characteristics, subsequent professional development, and research project characteristics. Factors associated with publication were identified by univariable and multivariable analysis with logistic regression. RESULTS: During the study period, 156 residents trained in our obstetrics-gynecology department. The overall publication rate was 30.8% (48/156) and the median time to publication 27 months (IQR, 18-37). The resident was first author in 36 (75.0%) publications. Among the 130 (83.3%) residents who completed the questionnaire, 43 (33%) had published their research project. Overall, 74/130 (60.8%) residents used their project for their mandatory medical thesis. Factors associated with publication in univariable analysis were younger age (median), completion of a PhD, planned career in academic medicine, prospective study design, presentation at a conference or congress and use their project for their medical thesis. The only factors associated with publication in the multivariable analysis were planned career in academic medicine (aOR 5.62 95 %CI[1.84-17.19]) and the prospective study design of the research project (aOR 6.1 95 %CI[1.24-29.56]). The main reasons for nonpublication reported by resident were lack of time and failure to complete the project. CONCLUSION: Among the mandatory clinical research projects conducted by obstetrics residents over a decade in our department, 30.8% were published. The main factors associated with publication were planned career in academic medicine and a prospective design of the research project.

Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial.

INTRODUCTION: It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins. METHODS AND ANALYSIS: We will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be ≥18 years with a singleton fetus in vertex presentation, at a term from ≥37+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score ≤6. Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment. ETHICS AND DISSEMINATION: All participants will provide written informed consent. The ethics committee 'Comité de Protection des Personnes Ile de France VII' approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences. TRIAL REGISTRATION NUMBER: NCT04949633.

Nulliparous women with an unfavourable cervix at 41 weeks: Which women go into spontaneous labor during the expectant period?

CONTEXT: After 41 weeks, the labor induction term varies according to countries and obstetrical teams. The French recommendations are not to exceed 41 weeks 6 days. However, there are no data on the percentage of nulliparous women with an unfavorable cervix at 41 weeks going into spontaneous labor within five or six days. OBJECTIVE: The objective was to establish the rate of spontaneous labor within five days amongst nulliparous women with an unfavorable cervix at 41 weeks, and to identify the maternal and obstetrical factors associated with this spontaneous labor. MATERIALS AND METHODS: Retrospective study in a University Hospital Maternity between January 1st and December 31st 2017. All nulliparous women with a cephalic fetal presentation and unfavorable cervix at 41 weeks (Bishop ≤ 3) were included. The maximum term for induced labor was set at 41 weeks 5 days. The population was divided into two groups: spontaneous labor and induced labor (induction between 41 weeks and 41 weeks 4 days for medical indications or maternal wish and induction at 41 weeks 5 days for full term). The maternal and obstetrical characteristics of the two groups at 41 weeks were compared as well as the maternal and neonatal outcomes. RESULTS: The rate of spontaneous labor among the 269 women included was 38.3% (n = 103/269). At 41 weeks, the presence of painful uterine contractions and a Bishop score of 3 were associated with spontaneous labor within five days (p < 0.01). The Bishop score criteria most associated with spontaneous labor were cervical dilation and fetal station. The cesarean delivery rate was 20.4% in the group of women with spontaneous labor versus 41.0% in the group of induced labor (p < 0.01). There were no differences between the two groups in terms of neonatal outcome. CONCLUSION: Among nulliparous women with an unfavorable cervix at 41 weeks, almost 40 % will have a spontaneous onset of labor within five days. The only factors found to be associated with this onset of labor are the presence of painful uterine contractions and a higher Bishop score at 41 weeks.