Balloon to Induce Labor in Generous Women. (BIGW)
Primary Purpose
Maternal Obesity
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Balloon catheter + oral misoprostol
Oral misoprostol alone
Sponsored by
About this trial
This is an interventional other trial for Maternal Obesity focused on measuring Induced labor, Maternal obesity
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
Sites / Locations
- CHU Clermont-Ferrand
- CHU St Etienne
- CHU Tours
- CHRU Lille
- CHU Antoine Beclère
- CHU Kremlin Bicêtre
- Centre hospitalier St Joseph
- CHI Poissy
- CHU Saint Denis de la Reunion
- CHU St Pierre de la Reunion
- CHU de Toulouse
- CHU Bordeaux
- CHU Nimes
- Hôpital St Joseph
- CHU Montpellier
- CHU Nantes
- CHU Poitiers
- CHU Fort de France
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Balloon catheter + oral misoprostol
Oral misoprostol alone
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Effectiveness criteria.
Effectiveness criteria chosen for the cost-effectiveness analysis will be the caesarean section rate for all indications.
Cost analysis.
Cost estimates, for the construction of ICER, will be performed from the health insurance perspective.
Costs taken into account will be those related to the management of obese pregnant women during inpatient stays for the delivery in both arms (i.e. combining method vs. oral prostaglandin alone). They include the costs of initial hospitalization for delivery. The expenses incurred in the management of patients in each arm will be recorded over a the study follow-up.
Resources consumption collection.
Resource consumption will be gathered prospectively in each arm, during the follow-up period using a bottom-up approach. Data will be collected from the Medical Information Departments of each center participating in the study for hospitalization costs.
Costs valuation.
Hospital stays will be valued from the French framework of pricing, the hospital Activity "Tarification à l'activité" (T2A). Hospital stays linked to the patient's care in each strategy will be valued from the French Diagnosis Related Group (DRGs).
Cost-effectiveness analysis.
A cost-effectiveness analysis will be performed from the health insurance perspective. An Incremental Cost Effectiveness Ratio (ICER) will be calculate to establish a link between costs and medical consequences, expressed in terms of rate of caesarian section rate, between the two strategies for labor induction.
Full Information
NCT ID
NCT03435458
First Posted
February 9, 2018
Last Updated
May 11, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03435458
Brief Title
Balloon to Induce Labor in Generous Women.
Acronym
BIGW
Official Title
Balloon to Induce Labor in Generous Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
interim analyses
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Obesity
Keywords
Induced labor, Maternal obesity
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
429 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balloon catheter + oral misoprostol
Arm Type
Experimental
Arm Title
Oral misoprostol alone
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
Balloon catheter + oral misoprostol
Intervention Description
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
Drug
Intervention Name(s)
Oral misoprostol alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Assessed by the caesarean section occurrence whatever the indication (binary endpoint).
Time Frame
Day 0 to day 2
Secondary Outcome Measure Information:
Title
Effectiveness criteria.
Description
Effectiveness criteria chosen for the cost-effectiveness analysis will be the caesarean section rate for all indications.
Time Frame
Day 0 to day 2
Title
Cost analysis.
Description
Cost estimates, for the construction of ICER, will be performed from the health insurance perspective.
Costs taken into account will be those related to the management of obese pregnant women during inpatient stays for the delivery in both arms (i.e. combining method vs. oral prostaglandin alone). They include the costs of initial hospitalization for delivery. The expenses incurred in the management of patients in each arm will be recorded over a the study follow-up.
Time Frame
Day 0 to day 2
Title
Resources consumption collection.
Description
Resource consumption will be gathered prospectively in each arm, during the follow-up period using a bottom-up approach. Data will be collected from the Medical Information Departments of each center participating in the study for hospitalization costs.
Time Frame
Day 0 to day 2
Title
Costs valuation.
Description
Hospital stays will be valued from the French framework of pricing, the hospital Activity "Tarification à l'activité" (T2A). Hospital stays linked to the patient's care in each strategy will be valued from the French Diagnosis Related Group (DRGs).
Time Frame
Day 0 to day 2
Title
Cost-effectiveness analysis.
Description
A cost-effectiveness analysis will be performed from the health insurance perspective. An Incremental Cost Effectiveness Ratio (ICER) will be calculate to establish a link between costs and medical consequences, expressed in terms of rate of caesarian section rate, between the two strategies for labor induction.
Time Frame
Day 0 to day 2
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Vayssiere, Pr
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
63000
Country
France
Facility Name
CHU St Etienne
City
Saint-Étienne
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
42055
Country
France
Facility Name
CHU Tours
City
Tours
State/Province
Centre-Val De Loire
ZIP/Postal Code
37044
Country
France
Facility Name
CHRU Lille
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59020
Country
France
Facility Name
CHU Antoine Beclère
City
Clamart
State/Province
Ile-de-France
ZIP/Postal Code
92140
Country
France
Facility Name
CHU Kremlin Bicêtre
City
Le Kremlin-Bicêtre
State/Province
Ile-de-France
ZIP/Postal Code
94270
Country
France
Facility Name
Centre hospitalier St Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France
Facility Name
CHI Poissy
City
Poissy
State/Province
Ile-de-France
ZIP/Postal Code
78300
Country
France
Facility Name
CHU Saint Denis de la Reunion
City
Saint-Denis
State/Province
La Réunion
ZIP/Postal Code
97400
Country
France
Facility Name
CHU St Pierre de la Reunion
City
Saint-Pierre
State/Province
La Réunion
ZIP/Postal Code
97448
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Bordeaux
City
Bordeaux
State/Province
Nouvelle Aquitaine
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Nimes
City
Nîmes
State/Province
Occitanie
ZIP/Postal Code
30900
Country
France
Facility Name
Hôpital St Joseph
City
Marseille
State/Province
Provence-Alpes-Côte d'Azur
ZIP/Postal Code
13008
Country
France
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
CHU Fort de France
City
Fort de France
Country
Martinique
12. IPD Sharing Statement
Citations:
PubMed Identifier
27500341
Citation
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.
Results Reference
background
PubMed Identifier
27018464
Citation
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.
Results Reference
background
PubMed Identifier
26244535
Citation
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.
Results Reference
background
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Balloon to Induce Labor in Generous Women.
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