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Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction

NCT05774236 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-06-11

No results posted yet for this study

Summary

The goal of this clinical trial is to compare how two methods for cervical ripening work in a population of singleton pregnancies with late-onset fetal growth restriction (FGR) at term.

The main question it aims to answer is whether Cook´s balloon (a mechanical method) is superior to vaginal dinoprostone (a pharmacological method) in achieving a vaginal delivery, without increasing neonatal morbidity.

Participants will be randomized to receive Cook´s balloon (experimental group) or vaginal dinoprostone (control group) for cervical ripening.

Researchers will compare both groups to see if Cook´s balloon is associated with a higher rate of vaginal delivery than vaginal dinoprostone and is not related to increased neonatal morbidity.

Conditions

  • Fetal Growth Retardation

Interventions

DEVICE

Cook´s balloon

Cervical ripening for induction of labor with a mechanical method (Cook´s balloon)

DRUG

Vaginal dinoprostone

Cervical ripening for induction of labor with a pharmacological method (vaginal dinoprostone)

Sponsors & Collaborators

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital Universitario 12 de Octubre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2025-05-23
Completion
2025-05-26

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774236 on ClinicalTrials.gov