← Back to all trials
Completed
NCT05774236
Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction
Conditions: Fetal Growth Retardation
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 172
Sponsor: Hospital Universitario 12 de Octubre
Location: Hospital Clinic i Provincial Barcelona Barcelona
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.
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. Neonatal outcomes (including neonatal acidosis, the MAIN morbidity score, and NICU admission) will be assessed as secondary, descriptive endpoints.
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:
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
Source: ClinicalTrials.gov (NCT05774236). StuddyBuddy aggregates publicly available trial information.