Balloon to Induce Labor in Generous Women.

NCT03435458 | Terminated Phase 3 DMC

• 1 other identifier: RC31/16/8911
• Study Type: interventional
• Target: 429
• Locations: 2 countries
• Sites: 18

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.

Conditions

Maternal Obesity

Keywords

Induced labor; Maternal obesity

Outcome Measures

Primary Outcomes (1)

• Efficacy of the association of mechanical and low dose oral misoprostol compared to oral misoprostol alone, to reduce the rate of caesarean section of all indications in obese women.

  Assessed by the caesarean section occurrence whatever the indication (binary endpoint).

  Day 0 to day 2

Secondary Outcomes (5)

• Effectiveness criteria.

  Day 0 to day 2

• Cost analysis.

  Day 0 to day 2

• Resources consumption collection.

  Day 0 to day 2

• Costs valuation.

  Day 0 to day 2

• Cost-effectiveness analysis.

  Day 0 to day 2

Study Arms (2)

Balloon catheter + oral misoprostol

EXPERIMENTAL

Combination Product: Balloon catheter + oral misoprostol

Oral misoprostol alone

ACTIVE COMPARATOR

Drug: Oral misoprostol alone

Interventions

Balloon catheter + oral misoprostol 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.

Balloon catheter + oral misoprostol

Oral misoprostol alone 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.

Oral misoprostol alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (18)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

Location

CHU St Etienne

Saint-Etienne, Auvergne-Rhône-Alpes, 42055, France

Location

CHU Tours

Tours, Centre-Val de Loire, 37044, France

Location

CHRU Lille

Lille, Hauts-de-France, 59020, France

Location

CHU Saint Denis de la Reunion

Saint-Denis, La Réunion, 97400, France

Location

CHU St Pierre de la Reunion

Saint-Pierre, La Réunion, 97448, France

Location

CHU de Toulouse

Toulouse, Midi-Pyrénées, 31059, France

Location

CHU Bordeaux

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

CHU Nimes

Nîmes, Occitanie, 30900, France

Location

Hôpital St Joseph

Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France

Location

CHU Montpellier

Montpellier, 34070, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Antoine Beclère

Clamart, Île-de-France Region, 92140, France

Location

CHU Kremlin Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

Location

Centre hospitalier St Joseph

Paris, Île-de-France Region, 75014, France

Location

CHI Poissy

Poissy, Île-de-France Region, 78300, France

Location

CHU Fort de France

Fort-de-France, Martinique

Location

Related Publications (4)

• 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.

  PMID: 27500341 BACKGROUND

• 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.

  PMID: 27018464 BACKGROUND

• 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.

  PMID: 26244535 BACKGROUND

• 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.

  PMID: 36996264 DERIVED

MeSH Terms

Conditions

Pregnancy in Obesity

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Christophe Vayssiere, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized, multicentre, open-label, controlled trial comparing association of balloon catheter plus oral prostaglandin E1 versus oral prostaglandin E1 alone to induce labor in a 1:1 randomization of nulliparous obese women.

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 19, 2018
• Study Start: June 26, 2020
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

FR (17); MA (1)