Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)
Fetal Growth Retardation
About this trial
This is an interventional treatment trial for Fetal Growth Retardation focused on measuring Fetal Growth Restriction, Cervical Ripening, Cook's Balloon, Dinoprostone, Labor Induction
Eligibility 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: Estimated fetal weight (EFW) < 3rd percentile 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
Sites / Locations
- Hospital Sant Joan de Déu
- Hospital Clinic i ProvincialRecruiting
- Hospital Universitario 12 de OctubreRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cook´s balloon
Vaginal dinoprostone
Silicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet
Vaginal delivery system containing 10 mg dinoprostone (Prostaglandin E2) dispersed throughout its matrix and releasing approximately 0.3 mg/hour dinoprostone over a 24-hour period.