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

• Status: Not yet recruiting
• Trial end date: 2025-09-27
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario 12 de Octubre
• Collaborators: Instituto de Salud Carlos III; Spanish Clinical Research Network - SCReN
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

• Singleton pregnancy

• Age ≥ 18 years

• Gestational age (GA) dated by first trimester ultrasound ≥ 37+0 weeks

• Cephalic presentation

• Stage I fetal growth restriction, defined as the presence of at least one of these two criteria:

1. Estimated fetal weight (EFW) < 3rd percentile

2. EFW < 10th percentile and at least one of the following: 2.1) Umbilical artery pulsatility index > 95th percentile or 2.2) Cerebral-placental index < 5th percentile

• Bishop score < 7

• Intact fetal membranes

• No previous caesarean section

• No contraindications for vaginal delivery or labor induction.

Exclusion Criteria:

• Major fetal malformation

• Fetal genetic abnormality

• Fetal congenital infection