Trial · NCT05774236
Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction
NCT05774236, Phase 3, Completed, Hospital Universitario 12 de Octubre
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction. Trials, record NCT05774236. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05774236
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction
- NCT number
- NCT05774236
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 172 participants, actual
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Conditions
- Fetal Growth Retardation
- Interventions
- Cook´s balloon, Vaginal dinoprostone
- First posted
- 2023-03-17
- Last updated
- 2026-07-27
- Other registries' IDs
- eudract:2021-001726-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of vaginal delivery | 2 days (from admission to delivery) | To assess whether cervical ripening with a Cook balloon for induction of labor of term pregnancies with FGR increases the rates of vaginal delivery with respect to the use of vaginal dinoprostone. |
| Secondary | Rate of cesarean sections due to suspected fetal distress | 2 days (from admission to delivery) | To assess whether cervical ripening with a Cook balloon for induction of labor of term pregnancies with FGR decreases the rates of cesarean sections due to suspected fetal distress with respect to the use of vaginal dinoprostone |
| Secondary | Induction-to-delivery interval | 2 days (from admission to delivery) | Comparison of the time interval between the onset of cervical ripening and delivery between the two arms |
| Secondary | Neonatal morbidity | From delivery to discharge of the newborn (up to 1 month) | To analyze the neonatal morbidity through the MAIN score (Morbidity assessment index for newborns) of neonatal morbidity and the duration of admissions to the Neonatal Intensive Care Unit (NICU). |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39349375 | DERIVED |
Source PubMed
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05774236
GET https://conductscience.org/api/trials/v1/NCT05774236/registered