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Objective: To assess the efficacy and safety of prostaglandin in inducing labor in pregnant women with one previous cesarean section. Secondly, to evaluate predictors of successful vaginal delivery in cervical ripening by prostaglandin in these women., Study Design: This was an observational, retrospective, single-center study conducted in a type 3 maternity unit at Bicêtre University Hospital between January 1, 2013 and December 31, 2016. Patients with one previous cesarean section, a singleton pregnancy, a fetus in the cephalic presentation with a medical indication for induction of labor and an unfavorable cervix (Bishop score less than 6) were included in the study. Cervical ripening was performed using a dinoprostone intravaginal device for a duration of 24 h., Results: A total of 153 patients were included in the study. The rate of vaginal delivery was 55.6 % (85/153) overall and 78.3 % (36/46) in the subgroup of 46 women with a previous vaginal delivery before or after the cesarean section. There was no difference in neonatal and maternal morbidity (defined by intraoperative wounds or postpartum hemorrhage or uterine rupture) and mortality between women who delivered vaginally and women who had a cesarean section. The two cases of complete uterine rupture have been reported for patients whose labor was induced by intravaginal prostaglandin followed by intravenous oxytocin. The total maternal morbidity rate was 11.8 % (n = 8/68) in the case of emergency cesarean section. Predictors of vaginal delivery were a history of vaginal delivery, the onset of labor following cervical ripening, and a higher Bishop score before and after the 24 h following the cervical ripening., Conclusion: Cervical ripening by prostaglandin after previous cesarean delivery has a 56 % success rate, with a 1.3 % risk of uterine rupture, especially when prostaglandin is combined with oxytocin. Low-risk patients should be identified to propose cervical ripening by prostaglandin., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: Labor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 h, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery., Methods: RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with two parallel arms running in six French hospitals. A total of 360 patients ≥ 18 years of age at > 37 weeks of gestation who exhibit unfavorable cervical conditions (Bishop score < 6) 24 h after placement of the first Propess®, with fetuses in cephalic presentation, will be included. Patients with premature membrane rupture, uterine scars, or multiple pregnancies will be excluded. Our principal objective is to determine whether placement of a second Propess® (followed by oxytocin [Syntocinon®], if necessary) in women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate is therefore the primary outcome. The secondary outcomes are the induction failure rates and maternofetal morbidity and mortality., Discussion: This study may help in determining the optimal way to induce labor after failure of a first Propess®, an unresolved problem to date. This trial explores the effectiveness and safety of placing a second Propess® and may contribute to development of an obstetric consensus., Trial Registration: Registered on 2 September 2016 at clinicaltrials.gov (identification number NCT02888041).

Background: There is no consensus about the ideal cervical ripening method to use for induction of labour., Objective: To compare in current practice the effectiveness and safety of four cervical ripening methods., Methods: We performed a matched comparative study using data from the MEDIP prospective population-based cohort conducted during one month in 2015 in all maternity units of seven French perinatal networks (3042 consecutive women with a live fetus and induction of labour). We analysed 1671 women with singleton cephalic fetus, unscarred uterus, and bishop score <7. Dinoprostone vaginal pessary (reference) was compared to dinoprostone vaginal gel, misoprostol vaginal tablet, and balloon catheter. Effectiveness outcomes were the need for more than one induction agent, oxytocin use, failure to achieve vaginal delivery within 24 hours (VD < 24 hours), and caesarean delivery. Safety outcomes were meconium-stained amniotic fluid, uterine hyperstimulation, NICU admission, and post-partum haemorrhage. Coarsened exact matching was used to balance confounders among the groups. Outcomes were compared using multivariable logistic regression models., Results: Compared to the dinoprostone pessary (N = 1142, 68.3%), dinoprostone gel (N = 335, 20.1%) was associated with less failure to achieve VD < 24 hours (adjusted OR 0.66, 95% CI 0.47, 0.91). Misoprostol (N = 103, 6.2%) was associated with less need of more than one induction agent (aOR 0.56, 95% CI 0.34, 0.92) and less oxytocin use (aOR 0.60, 95% CI 0.37, 0.99). The balloon catheter (N = 91, 5.4%) was associated with more failure to achieve VD < 24 hours (aOR 2.62, 95% CI 1.37, 5.01), more caesarean delivery (aOR 1.84, 95% CI 1.09, 3.08), and less meconium-stained amniotic fluid (aOR 0.12, 95% CI 0.02, 0.70). Uterine hyperstimulation rates seemed lower with the balloon catheter (1.2% vs 4.2% for the pessary)., Conclusions: In current practice, no cervical ripening method appears clearly superior to the others considering all effectiveness and safety outcomes., (© 2019 John Wiley & Sons Ltd.)

Research Question: To determine whether adding intramuscular to vaginal administration of progesterone reduces miscarriage rates compared with those of vaginal administration alone for luteal phase support in women receiving oocyte donation and to determine the best time to introduce intramuscular progesterone., Design: Retrospective analysis of miscarriage rates in women receiving oocyte donation. Recipients underwent endometrial preparation by hormone replacement treatment. Vaginal progesterone alone or associated with intramuscular progesterone was used for luteal support., Results: This study analysed 186 oocyte donation cycles from January 2016 to May 2018 with embryo transfer on Day 2 or 3 and vaginal progesterone administration: 106 embryo transfer cycles with vaginal progesterone alone, 29 with weekly intramuscular progesterone added once the human chorionic gonadotrophin (HCG) assay was positive, and 51 with weekly intramuscular progesterone added the evening of embryo transfer. The rates of positive HCG assays, biochemical pregnancies and clinical pregnancies did not differ between the treatment groups. The miscarriage rate was significantly lower when intramuscular progesterone began the evening of embryo transfer than with vaginal administration alone (16.7% versus 47.0%, respectively; P = 0.049 after Bonferroni correction). The live birth rate was higher when intramuscular progesterone began the evening of embryo transfer than with vaginal administration alone (37.3% versus 16.0%, respectively; P = 0.009 after Bonferroni correction)., Conclusions: Adding intramuscular to vaginal progesterone administration appears to decrease the miscarriage rate and increase the live birth rate in oocyte donations. The initiation of intramuscular progesterone is most beneficial when it is introduced the evening of embryo transfer., (Copyright © 2019 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Introduction: Premature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature., Methods and Analysis: We are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups-with a statistical power of 90% and a two-tailed α of 5%-40 patients per group will be required., Ethics and Dissemination: Written informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team., Trial Registration Number: NCT03310333., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Hormonal and intrauterine contraceptive methods provide women with highly efficient protection against undesired pregnancy. Additional non-contraceptive effects are now well documented. Combined hormonal contraceptives use, either through the oral transdermal and vaginal route, allow a reduction in menorrhagia, dysmenorrhea, functional ovarian cysts, benign breast and uterine disease, endometriosis-related pain and recurrence. A reduction in ovarian cancer risks, including in women with BRCA syndrome, endometrial and colon cancer is documented. This effect is prolonged for years after contraception discontinuation. Non-contraceptive benefits of progestin-only contraceptives are less documented. Use of the levonorgestrel IUD is associated with a reduction in menorrhagia, dysmenorrhea including in case of endometriosis. Copper IUD use is associated with a decrease in cervix and endometrial cancer risk., (Copyright © 2018. Published by Elsevier Masson SAS.)

The literature suggests that misoprostol can be offered to patients for off-label use as it has reasonable efficacy, risk/benefit ratio, tolerance and patient satisfaction, according to the criteria for evidence-based medicine. Both the vaginal and sublingual routes are more effective than the oral route for first-trimester cervical dilatation. Vaginal misoprostol 800μg, repeated if necessary after 24 or 48h, is a possible alternative for management after early pregnancy failure. However, misoprostol has not been demonstrated to be useful for the evacuation of an incomplete miscarriage, except for cervical dilatation before vacuum aspiration. Oral mifepristone 200mg, followed 24-48h later by vaginal, sublingual or buccal misoprostol 800μg (followed 3-4h later, if necessary, by misoprostol 400μg) is a less efficacious but less aggressive alternative to vacuum aspiration for elective or medically-indicated first-trimester terminations; this alternative becomes increasingly less effective as gestational age increases. In the second trimester, vaginal misoprostol 800-2400μg in 24h, 24-48h after at least 200mg of mifepristone, is an alternative to surgery, sulprostone and gemeprost. Data for the third trimester are sparse. For women with an unripe cervix and an unscarred uterus, vaginal misoprostol 25μg every 3-6h is an alternative to prostaglandin E2 for cervical ripening at term for a live fetus. When oxytocin is unavailable, misoprostol can be used after delivery for prevention (sublingual misoprostol 600μg) and treatment (sublingual misoprostol 800μg) of postpartum haemorrhage. The use of misoprostol to promote cervical dilatation before diagnostic hysteroscopy or surgical procedures is beneficial for premenopausal women but not for postmenopausal women. Nonetheless, in view of the side effects of misoprostol, its use as a first-line treatment is not indicated, and it should be reserved for difficult cases. Misoprostol is not useful for placing or removing the types of intra-uterine devices used in Europe, regardless of parity., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objectives: Labor induction is one of the most frequent procedures during pregnancy in France. In most cases, the cervix is unriped. Guidelines regarding cervical ripening are heterogeneous in terms of molecules, administration route, dosage or surveillance. The objective was to describe how international recommendations are applied in French teaching maternities., Methods: This is a national telephone survey for all 46 obstetrical departments. For each center, the obstetrician in charge was contacted., Results: All of the 46 maternities were accounted for. All of them assessed cervical status clinically, defined as riped for a Bishop score≥7 for 90.2% of the maternities. Ripening evaluation depended on parity for 56.5% of them. Cervical ripening was performed near a surgical unit in case of a cesarean section for 82.6% of the maternities. The most common method used the controlled-released pessary of dinoprostone (89.1%) followed by intra-vaginal dinoprostone (65.2%), the foley catheter (50.0%) and misoprostol (17.4%)., Discussion and Conclusion: Numbers of methods of cervical ripening and protocols of administration and surveillance varied widely between obstetrical departments, sometimes even in contradiction to guidelines and review of the litterature. Controlled-released pessary and intra-vaginal gel of dinoprostone were the most common molecules used for cervical ripening. Differences in protocols should be analyzed on their efficiency to establish consensus-based recommendations., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Objective: State of knowledge about misoprostol's use out of its marketing authorization during the first trimester of pregnancy, in early miscarriage or to induce abortion or medical termination of pregnancy., Methods: French and English publications were searched using PubMed, Cochrane Library and international learned societies recommendations., Results: Cervical ripening prior to surgical uterine evacuation during the first trimester of pregnancy facilitates cervical dilatation and reduces operative time and uterine retention risk. Misoprostol, mifepristone and osmotic cervical dilators are equally efficient. Concerning first trimester miscarriage, surgical uterine evacuation remains the most effective and the quickest method of treatment (EL 1). Depending on the clinical situation, medical treatment using misoprostol (missed miscarriage) or expectative attitude (incomplete miscarriage) does not increase the risk of complications, neither haemorrhagic nor infectious (EL 1). However, these alternatives generally require longer outpatient follow-up, which leads to more consultations, prolonged bleeding and not planned surgical procedures (EL 1). Concerning missed miscarriage, a vaginal dose of 800 μg of misoprostol, possibly repeated 24 to 48 hours later, seems to offer the best efficiency/tolerance ratio (EL 2). Concerning early abortion, medical method is a safe and efficient alternative to surgery (EL 2). Success rates are inversely proportional to gestational age (EL 2). According to the modalities of its marketing authorization, 400 μg of misoprostol can only be given by oral route, for less than 7 weeks of amenorrhea (WA) pregnancies and after 36 to 48 hours following 600 mg of mifepristone (EL 1). However, 200mg of mifepristone is as efficient as 600 mg (EL 1). Beyond 7WA, misoprostol buccal dissolution (sublingual or prejugal) or vaginal administration are more efficient and better tolerated than oral ingestion (EL 1). Between 7 and 9WA, the best protocol in terms of efficiency and tolerance is the association of 200mg of mifepristone followed 24 to 48 hours later by 800 μg of vaginal, sublingual or buccal misoprostol (EL 1). An additional dose of 400 μg can be given 3 hours later if necessary (EL 3). In case of buccal administration, the dose of 400 μg seems to offer the same efficiency with a better tolerance but further evaluation is needed (EL 2). Between 9 and 12WA, medical treatment is less efficient than surgery and its tolerance is lower (EL 2). However, a protocol of 200mg of mifepristone followed 36 to 48 hours later by 800 μg of vaginal or sublingual misoprostol, plus an additional 400 μg dose every 3-4 hours (until 4-5 doses maximum) seems safe and efficient (EL 5)., Conclusion: Misoprostol use during the first trimester of pregnancy is a safe and efficient alternative to surgery as long as detailed protocols adjusted to each clinical situation are respected., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Progesterone was widely used in France during the 1980s and 1990s to prevent preterm birth until some published cases of cholestasis suddenly stopped its prescription. Since then, multiple randomized controlled trials have emerged and demonstrated the efficiency of the treatment but also its safety at low doses. In order to clarify its indications, we performed a current literature review. We analyzed literature data according to different categories of risk and different routes of administration. Results confirm that progesterone is an efficient treatment to prevent preterm birth in singleton gestation with short cervical length, and in singleton gestation with prior preterm birth with or without short cervical length. Apart from these indications, progesterone, especially 17-alpha-hydroxyprogesterone (17OHP), should not be used outside research protocols., (Copyright © 2014. Published by Elsevier SAS.)

Objective: To evaluate the safety and efficacy of termination of pregnancy using mifepristone and misosprostol at more than 15 weeks' gestation in patients with uterine scar due to previous cesarean section., Materials and Methods: This retrospective study was conducted in a tertiary maternity ward between January 2000 and October 2004. A total of 252 women at more than 15 weeks' gestation underwent termination of pregnancy including 50 women with uterine scar due to previous cesarean section (Group 1) and 202 control patients (Group 2) without known uterine scar. Abortion was induced with mifepristone and a prostaglandin analogue. Women between 15 and 34 weeks' gestation received misoprostol intravaginally every 3 h at doses of 200 microg (Group 1) or 400 microg (Group 2). Women at more than 34 weeks' gestation received Prostin E2 vaginal gel. Main end points were hemorrhage, fever, retained placenta, occurrence of complications including uterine rupture and dehiscence, and final outcome., Results: A total of 13 (26%) patients in Group 1 and 79 (39.1%) in Group 2 were at more than 24 weeks' gestation. The abortion failure rate was 2% (1/50) in Group 1 and 0.5% (1/202) in Group 2 (p = .28). The median induction-to-delivery interval was 8.5 h (range, 3.0-114.2 h) for Group 1 and 9.0 h (range, 1.3-124.3 h) in Group 2 (p = .26). One case of uterine rupture and one case of dehiscence were observed, both in women in Group 1. The incidence of hemorrhage was not significantly different between Group 1 and Group 2 (2% vs. 0.9%, respectively, p = .56). The incidence of retained placenta was higher in the Group 1 (70% vs. 52.5%, respectively, p = .025)., Conclusion: In this retrospective series of women who underwent abortion at 15-35 weeks' gestation using mifepristone and a prostaglandin analogue for labor induction abortion, history of cesarean section was not associated with higher morbidity except risk of uterine rupture. However, dose and interval of misoprostol should be determined. A larger study is needed before drawing definitive conclusions about the safety of these regimens.

Objective: The Protectaid sponge (Gefar Pharma, Switzerland) is a new feminine barrier contraceptive method containing three low-dose spermicidal agents. In order to evaluate its efficacy and safety profiles, an international, multicenter study has been conducted in four countries., Methods: Healthy, presumably fertile and sexually active women were enrolled in this study and were followed at 15 days, 3, 6, 9 and 12 months. Contraceptive efficacy was assessed by a pregnancy test, while safety was evaluated by performing gynecological examinations as well as reporting adverse events. The 'acceptability' of the sponge by the women was assessed through a standard questionnaire., Results: A total of 129 women were enrolled in the study, generating 1182 cycles of use of the sponge. The overall efficacy rate was 77%, with no significant influence of age or parity. Acceptability was high, with 85% of subjects being symptom- or problem-free while using the sponge. Finally, the safety profile was very good, with no clinically significant evidence of local or systemic adverse reactions., Conclusion: The new Protectaid sponge is a safe and effective non-hormonal contraceptive method for women.

Objective: To evaluate comparatively the acceptability and safety of a new pharmaceutical form of benzalkonium chloride, the vaginal capsule, with the pessary form., Methods: Eighty-nine women were randomized to receive either a benzalkonium chloride vaginal capsule or a benzalkonium chloride pessary prior to sexual intercourse according to an open cross-over design over a 2-month study period., Results: The discomfort caused by delayed leakage or discharge was mild. The mean scores for subjective signs (burning, itching, vulvar pruritus) were also mild and were comparable for the two formulations. The capsule appeared to be slightly superior to the pessary regarding discomfort caused by immediate discharge or leakage, ease of use and acceptance by the woman's partner. Local safety was generally good. Adverse events consisted chiefly of vulvar pruritus and a vaginal or vulvar burning sensation, with a higher incidence being associated with the pessary than the capsule. All symptoms regressed spontaneously after the end of treatment., Conclusions: This study demonstrated good acceptability and good local safety for the benzalkonium chloride vaginal capsule. It is essential to take these parameters into consideration in the evaluation of any local spermicidal contraceptive, since they play a large part in compliance with, and thus in the efficacy of, the product under assessment.

Termination of early pregnancy (less than 49 days of amenorrhea) was induced in 75 patients with the combination of the antigestagen mifepristone and a prostaglandin analogue, meteneprost. After 48 h a single oral dose of 600 mg of mifepristone was followed by a 10 mg meteneprost vaginal pessary. Pregnancy was confirmed by clinical and ultrasound examinations and plasma HCG assessment. Complete abortion occurred in 72 patients (96%) and the three others required a surgical uterine aspiration. Bleeding continued for 4 to 12 days (mean = 8). Uterine pain and side effects occurred during the 3 h following the use of prostaglandin. Only minor analgesic were required in 30 patients. The combination of mifepristone and meteneprost is a safe and effective method to terminate an early pregnancy.