Trial · NCT03435458
Balloon to Induce Labor in Generous Women.
NCT03435458, Phase 3, Terminated, University Hospital, Toulouse
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Balloon to Induce Labor in Generous Women. Trials, record NCT03435458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03435458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Balloon to Induce Labor in Generous Women.
- NCT number
- NCT03435458
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 429 participants, actual
- Lead sponsor
- University Hospital, Toulouse
- Conditions
- Maternal Obesity
- Interventions
- Balloon catheter + oral misoprostol, Oral misoprostol alone
- First posted
- 2018-02-19
- Last updated
- 2023-05-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | Day 0 to day 2 | Assessed by the caesarean section occurrence whatever the indication (binary endpoint). |
| Secondary | Effectiveness criteria. | Day 0 to day 2 | Effectiveness criteria chosen for the cost-effectiveness analysis will be the caesarean section rate for all indications. |
| Secondary | Cost analysis. | Day 0 to day 2 | 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. |
| Secondary | Resources consumption collection. | Day 0 to day 2 | 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. |
| Secondary | Costs valuation. | Day 0 to day 2 | 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). |
| Secondary | Cost-effectiveness analysis. | Day 0 to day 2 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03435458
GET https://conductscience.org/api/trials/v1/NCT03435458/registered