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

COLIGROW

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.

2023-03-27

2025-05-27

2025-09-27

Recruiting

Early phase I

172

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, randomized (1:1), open-label, 2-arm parallel group, controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}}, 'enrollmentInfo': {'count': 172, 'type': 'ESTIMATED'}}

2023-04-25