Maternal ObesityPhase 3BIGWNCT03435458
Balloon to Induce Labor in Generous Women.
A Phase 3 study testing Balloon catheter + oral misoprostol and Oral misoprostol alone in people with Maternal Obesity, run by University Hospital, Toulouse at 18 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Obesity
- What is being tested?
- Balloon catheter + oral misoprostol and Oral misoprostol alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 26 Jun 2020to 2 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- pregestational BMI ≥ 30 kg/m2 (weight/height2)
- singleton pregnancy with cephalic presentation
- nulliparous
- ≥ 36 weeks gestational age
- decision of induction of labor
Show all 12Show fewer
- 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
Who cannot join
- deceleration on Fetal Heart Rate (FHR)
- placenta praevia
- bleeding
- premature rupture of membrane
- chorioamnionitis
- allergy to prostaglandins
Show all 11Show fewer
- contraindication to ballon
- active genital herpes infection
- HIV infection
- fetal serious congenital anomaly
- patient subject to a legal protection order
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
France17 sites
CHU Bordeaux
Bordeaux, New Aquitaine, 33076
CHU Antoine Beclère
Clamart, Île-de-France Region, 92140
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000
CHU Kremlin Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94270
CHRU Lille
Lille, Hauts-de-France, 59020
Hôpital St Joseph
Marseille, Provence-Alpes-Côte d'Azur Region, 13008
CHU Montpellier
Montpellier, 34070
CHU Nantes
Nantes, 44093
CHU Nimes
Nîmes, Occitanie, 30900
Centre hospitalier St Joseph
Paris, Île-de-France Region, 75014
CHI Poissy
Poissy, Île-de-France Region, 78300
CHU Poitiers
Poitiers
CHU Saint Denis de la Reunion
Saint-Denis, La Réunion, 97400
CHU St Etienne
Saint-Etienne, Auvergne-Rhône-Alpes, 42055
CHU St Pierre de la Reunion
Saint-Pierre, La Réunion, 97448
CHU de Toulouse
Toulouse, Midi-Pyrénées, 31059
CHU Tours
Tours, Centre-Val de Loire, 37044
About this study
Official title: Balloon to Induce Labor in Generous Women
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.
Read the 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
- Being tested
- Balloon catheter + oral misoprostol, Oral misoprostol alone
- Keywords
- Induced labor, Maternal obesity
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon catheter + oral misoprostolCombination 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 aloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Balloon catheter + oral misoprostol | Experimental | Not described Receives: Combination Product: Balloon catheter + oral misoprostol |
| Oral misoprostol alone | Active comparator | Not described Receives: Drug: Oral misoprostol alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0 to day 2
Secondary outcomes (5)
Effectiveness criteria.
Effectiveness criteria chosen for the cost-effectiveness analysis will be the caesarean section rate for all indications.
Measured: Day 0 to day 2
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.
Measured: Day 0 to day 2
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.
Measured: Day 0 to day 2
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).
Measured: Day 0 to day 2
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.
Measured: Day 0 to day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start26 Jun 2020
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Why it stopped: interim analyses
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Vayssiere, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435458
- Sponsor's protocol ID
- RC31/16/8911
- Acronym
- BIGW
- Status last verified
- May 2023
- First submitted
- 9 Feb 2018
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27500341Connolly 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.
PubMed 27018464McMaster 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.
PubMed 26244535de 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.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon to Induce Labor in Generous Women
- ClinicalTrials.gov ID
- NCT03435458
- Acronym / sponsor ID
- BIGW / RC31/16/8911
- Conditions
- Maternal Obesity
- Keywords
- Induced labor, Maternal obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analyses
- Enrolment
- 429 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balloon catheter + oral misoprostol | Experimental | Combination Product: Balloon catheter + oral misoprostol |
| Oral misoprostol alone | Active comparator | Drug: Oral misoprostol alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- female
- pregestational BMI ≥ 30 kg/m2 (weight/height2)
- singleton pregnancy with cephalic presentation
- nulliparous
- ≥ 36 weeks gestational age
Key exclusion criteria (11 listed)
- deceleration on Fetal Heart Rate (FHR)
- placenta praevia
- bleeding
- premature rupture of membrane
- chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon catheter + oral misoprostolThe 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. | Combination product | Balloon catheter + oral misoprostol |
| Oral misoprostol alonePatients 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. | Drug | Oral misoprostol alone |
Primary outcome
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.
Time frame: Day 0 to day 2
Assessed by the caesarean section occurrence whatever the indication (binary endpoint).
5 secondary outcomes
Effectiveness criteria.
Time frame: Day 0 to day 2
Cost analysis.
Time frame: Day 0 to day 2
Resources consumption collection.
Time frame: Day 0 to day 2
Costs valuation.
Time frame: Day 0 to day 2
Cost-effectiveness analysis.
Time frame: Day 0 to day 2
Results and safety
The study was stopped early (reason given: interim analyses). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Background: PubMed 27500341Battarbee 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.
- Background: PubMed 27018464Connolly 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.
- Background: PubMed 26244535McMaster 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.
- Derived from this study: PubMed 36996264de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Vayssiere, Pr principal investigator
University Hospital, Toulouse
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Balloon catheter + oral misoprostol and Oral misoprostol alone in people with Maternal Obesity, run by University Hospital, Toulouse at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: interim analyses). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 0 to day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435458, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.