Clinical Research Directory

Evaluation of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening

The goal of this clinical trial is to learn about the safety and performance of the INGA Sensor System when used with the INGA balloon catheter during cervical ripening for labor induction in pregnant individuals at term. Cervical ripening is a process used to prepare the cervix for labor. The main questions it aims to answer are: * Is the INGA Sensor System safe to use during cervical ripening with the INGA balloon catheter? * How well does the sensor system measure uterine contractions and fetal heart rate during cervical ripening? * How does the use of the INGA balloon catheter affect cervical ripening and the time from induction to delivery? * How do participants and healthcare professionals evaluate the usability of the catheter and sensor system? All participants in this study will receive the INGA balloon catheter with the attached sensor system. There is no comparison group. Participants will: * Undergo routine assessments before labor induction, including medical history review, cervical examination, blood pressure and heart rate measurement, and fetal heart rate monitoring * Have the INGA balloon catheter placed in the cervix by a trained physician * Have a small sensor device attached to the external end of the catheter * Undergo standard fetal heart rate monitoring after placement * Keep the catheter and sensor in place until the catheter is expelled naturally or for up to 24 hours * Continue labor induction and delivery according to standard hospital practice * Complete a questionnaire about comfort and usability * Allow collection of information about labor, delivery, and newborn outcomes from medical records Participation lasts from signing informed consent until hospital discharge.

Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)

The goal of this clinical study is to evaluate a new mechanical balloon catheter (INGA) used to prepare the cervix for labor induction in pregnant women at term. The study aims to assess the safety, usability, and performance of the INGA catheter when used for cervical ripening before labor. Researchers will also collect feedback from healthcare professionals and participants about the use of the device. Participants are pregnant women at term with a single baby in a head-down position who meet the study eligibility criteria. Participants will: * have the INGA balloon catheter inserted as part of labor induction, * receive standard clinical care according to hospital practice, * provide information about their experience and outcomes related to the device. The results of this study will help determine whether the INGA catheter is safe and suitable for use in cervical ripening during labor induction.

PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)

This study is being done to learn more about the best way to start labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes (term PROM). When this happens and the cervix is not ready for labor, it is unclear which induction method works best and is safest for mother and baby. The purpose of this study is to compare two common ways to induce labor in women with term PROM and an unfavorable cervix (Bishop score ≤ 6). One group will receive a vaginal dinoprostone insert (Propess) for 6 hours to soften the cervix, followed by oxytocin if labor does not start. The other group will receive immediate oxytocin through a vein. Pregnant women aged 18 years or older with a single baby in head-down position at 37-42 weeks, whose water has broken and whose cervix is not yet favorable, may be able to join this study. All care will be provided at the National Hospital of Obstetrics and Gynecology in Hanoi, Vietnam, where both medicines are already used in routine practice. The main outcome is how many women have a vaginal birth. The study will also look at how long it takes from induction to birth, complications for mothers and babies, and women's experiences of labor. The results may help doctors choose the safest and most effective way to induce labor for women with term PROM in the future.

Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction

This study investigates the safety and usability of the new INGA catheter for labor induction. Labor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. The INGA catheter is a single-balloon device that works similarly to a Foley catheter but is made from different materials. Feedback will be collected from both healthcare professionals and participating women.

Combined Nipple Stimulation and Foley Balloon for Cervical Ripening

Labor induction rates have increased substantially worldwide, and successful cervical ripening remains a key determinant of induction outcomes. Mechanical cervical ripening with a Foley balloon catheter is widely used and considered safe, while nipple stimulation promotes endogenous oxytocin release and represents a physiologic method for stimulating uterine contractions. However, the combined effect of nipple stimulation and balloon catheter use has not been systematically evaluated. This prospective, randomized, double-blinded controlled trial will assess whether the addition of nipple stimulation to Foley balloon catheter cervical ripening improves Bishop score and shortens the induction-to-delivery interval compared with balloon catheter alone. Term pregnant patients (37-42 weeks' gestation) with a singleton, cephalic pregnancy and an unfavorable cervix (Bishop score \<6) requiring labor induction will be randomized to receive either Foley balloon catheter plus standardized nipple stimulation or Foley balloon catheter alone. The primary outcomes are change in Bishop score after catheter removal and time from catheter insertion to delivery. Secondary outcomes include need for additional induction methods, mode of delivery, maternal and neonatal outcomes, pain, patient satisfaction, and breastfeeding rates. The study aims to evaluate the efficacy and safety of incorporating a physiologic intervention into standard mechanical cervical ripening.

Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening

Twenty-two percent of deliveries in France are induced. In cases where labor is induced and cervix is unfavorable, cervical ripening prior oxytocin administration is advised in order to reduce the risk of cesarean delivery. Cervical ripening agents, pharmacological (prostaglandins) or mechanical are administered during 24 hours. After 24 hours, most women will be either delivered or in labor but 25% of women will require further induction of labor. For 16% of women who undergo cervical ripening, whatever the cervical ripening method, the cervix remains unchanged after 24 hours. The management of these women is not consensual and depends on the maternity unit where women are cared for. This study seeks to identify the most appropriate strategy for the management of women with an unfavorable cervix after 24 hours of cervical ripening, a strategy which would be associated with the lowest maternal and perinatal morbidity but also with the best maternal satisfaction. Because both strategies are practiced in France, the trial would compare: induction of labor with oxytocin and repeated cervical ripening. The aim is to show that repeating cervical ripening is an unnecessary procedure. And more specifically that oxytocin administration is not associated with a higher caesarean delivery rate and that it reduces the time to delivery in comparison with cervical ripening with prostaglandins.

The SWEEP Trial: a Randomized Controlled Trial

The purpose of this clinical trial is to determine whether serial membrane sweeping at term is more effective than no membrane sweeping in promoting spontaneous onset of labor. The primary research question is whether serial membrane sweeping increases the likelihood of birth before gestational age 41+3 with spontaneous onset of labor. A total of 1536 participants will be randomized between gestational age 39+5 and 40+2 to either no membrane sweeping or up to three membrane sweepings performed 2-3 days apart. Researchers will collect data from the electronic medical record and participants will be asked to complete a short daily questionnaire on pregnancy symptoms and, in the intervention group, their experience of membrane sweeping from randomization until birth. All participants will be asked to complete a follow-up questionnaire about their birth experience five weeks postpartum

Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial

This randomized controlled trial compared misoprostol and isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. Low-risk women at 41+6 weeks gestation with an unfavorable cervix were randomized to receive either misoprostol or IMN. The primary outcome was the achievement of cervical ripeness (Bishop Score ≥6) within 40 hours.

Membrane Stripping for Cervical Ripening

The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction. The study population consists of women undergoing labor induction. The main questions it aims to answer are: 1. Is membrane stripping as effective as double balloon catheter induction in cervical ripening? 2. What is the influence of membrane stripping on the time required for cervical ripening, delivery duration, and maternal and fetal outcomes compared to balloon induction.