Balloon to Induce Labor in Generous Women.

NCT ID: NCT03435458

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 429 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-26
• Study Completion Date: 2023-02-02

Brief Summary

The rate of obesity increases continuously in France as in many developing countries.The risk of cesarean delivery is increased in obese compared to normal-weight women and postpartum complications as infections, thromboembolic events and related maternal death, are more common among obese women who deliver by cesarean than both normal-weight women with caesarean deliveries and obese women with vaginal deliveries. Unfortunately, obesity is associated with a higher rate of failed induction requiring a cesarean delivery and especially in nulliparous.

Methods of induction for obese women have to be improved to decrease the c-section rate but investigators should also be cautious on the type and dose of PG not to affect the neonatal wellbeing associated with uterine hyperstimulation.

The aim of this study is to demonstrate the efficacy of the association of mechanical and pharmacological cervical ripening (balloon catheter plus 50 µg oral prostaglandin E1) versus pharmacological cervical ripening alone (50 µg oral prostaglandin E1) to reduce the rate of caesarean sections in nulliparous obese women.

Detailed Description

The rate of obesity increases continuously in France as in many developing countries. In 2012, in the US, one third of all pregnant women were obese. The risk of cesarean delivery is increased in obese compared to normal-weight women and postpartum complications as infections, thromboembolic events and related maternal death, are more common among obese women who deliver by cesarean than both normal-weight women with caesarean deliveries and obese women with vaginal deliveries.

Prevalence of post-term is increased in obese pregnant women and the rate of induction of labor is twice the rate of normal-weight women, 42% versus 23% in the 2010 French National Survey.

Unfortunately, obesity is associated with a higher rate of failed induction requiring a cesarean delivery and especially in nulliparous.

Methods of induction for obese women have to be improved to decrease the c-section rate but investigators should also be cautious on the type and dose of PG not to affect the neonatal wellbeing associated with uterine hyperstimulation.

In a recent randomized clinical trial (RCT), the rate of c-section after labor induction in obese women was not increased in obese women compared to normal-weight women with balloon catheter but it was also increased with prostaglandin E2 (PGE2) and moreover with higher rate of uterine hyperstimulation. Recently, low dose of oral misoprostol (PGE1) has been showed to be the drug with the lowest rate of c-section after induction of labor in all women and balloon catheter to be associated with the lowest rate of hyperstimulation. Because safety of these two specific methods for induction of labor, a comparison 1 to 1 were done recently for induction of labor in singletons with comparable results.

Very few studies have focused on induction of labor in obese women even if the rate of maternal and neonatal complications are higher.

The efficacy of combining these two methods with different mechanism of induction have been showed recently but no study has been published today on obese women. Recently a trial have showed a shorter induction-delivery time with the combination (misoprostol-foley) for induction of labor in the whole population with less need of oxytocin during labor without more complications neither for the mother nor for the baby.An induction will be considered "failed" if at least 12 hours have elapsed since both rupture of membranes and use of a uterine stimulant and the patient remains in latent labor.

The aim of this study is to demonstrate the efficacy of the association of mechanical and pharmacological cervical ripening (balloon catheter plus 50 µg oral prostaglandin E1) versus pharmacological cervical ripening alone (50 µg oral prostaglandin E1) to reduce the rate of caesarean sections in nulliparous obese women.

Conditions

Maternal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Balloon catheter + oral misoprostol

Group Type: EXPERIMENTAL

Balloon catheter + oral misoprostol

Intervention Type: COMBINATION_PRODUCT

The pharmacological cervical ripening will be administered just after the balloon catheter insertion (after coming back in her room) and will consist of misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.

Oral misoprostol alone

Group Type: ACTIVE_COMPARATOR

Oral misoprostol alone

Intervention Type: DRUG

Patients will receive a pharmacological cervical ripening alone that consist of Misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.

Interventions

Balloon catheter + oral misoprostol

The pharmacological cervical ripening will be administered just after the balloon catheter insertion (after coming back in her room) and will consist of misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.

Intervention Type: COMBINATION_PRODUCT

Oral misoprostol alone

Patients will receive a pharmacological cervical ripening alone that consist of Misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• female
• pregestational BMI ≥ 30 kg/m2 (weight/height2)
• singleton pregnancy with cephalic presentation
• nulliparous
• ≥ 36 weeks gestational age
• decision of induction of labor
• bishop score ≤ 5
• ≤ 3 uterine contractions / 10 min
• ≥ 18 years of age
• personally signed and dated informed consent document
• ability to comply with the requirement of the study
• insurance coverage

Exclusion Criteria

• deceleration on Fetal Heart Rate (FHR)
• placenta praevia
• bleeding
• premature rupture of membrane
• chorioamnionitis
• allergy to prostaglandins
• contraindication to ballon
• active genital herpes infection
• HIV infection
• fetal serious congenital anomaly
• patient subject to a legal protection order

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Vayssiere, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

CHU St Etienne

Saint-Etienne, Auvergne-Rhône-Alpes, France

CHU Tours

Tours, Centre-Val de Loire, France

CHRU Lille

Lille, Hauts-de-France, France

CHU Saint Denis de la Reunion

Saint-Denis, La Réunion, France

CHU St Pierre de la Reunion

Saint-Pierre, La Réunion, France

CHU de Toulouse

Toulouse, Midi-Pyrénées, France

CHU Bordeaux

Bordeaux, Nouvelle-Aquitaine, France

CHU Nimes

Nîmes, Occitanie, France

Hôpital St Joseph

Marseille, Provence-Alpes-Côte d'Azur Region, France

CHU Montpellier

Montpellier, , France

CHU Nantes

Nantes, , France

CHU Poitiers

Poitiers, , France

CHU Antoine Beclère

Clamart, Île-de-France Region, France

CHU Kremlin Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, France

Centre hospitalier St Joseph

Paris, Île-de-France Region, France

CHI Poissy

Poissy, Île-de-France Region, France

CHU Fort de France

Fort-de-France, , Martinique

Countries

France; Martinique

References

Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.

Reference Type: BACKGROUND

PMID: 27500341 (View on PubMed)

Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.

Reference Type: BACKGROUND

PMID: 27018464 (View on PubMed)

McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.

Reference Type: BACKGROUND

PMID: 26244535 (View on PubMed)

de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type: DERIVED

PMID: 36996264 (View on PubMed)

Other Identifiers

RC31/16/8911

Identifier Type: -

Identifier Source: org_study_id