NCT05774236

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Hospital Universitario 12 de Octubre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Late-onset fetal growth restriction (FGR) represents the most common subtype of FGR (70-80%). The greatest risk for these fetuses appears once term pregnancy is reached, when stressful situations are added to their status of relative hypoxia, such as the appearance of contractions and funicular compression. Thus, it has been shown that from week 37-38 the risk of intrauterine mortality increases and there is a general consensus not to prolong these pregnancies beyond this period. In this situation, induction of labor is usually preferred over elective caesarean delivery. However, these fetuses have an increased risk of cesarean section for suspected fetal distress. Mechanical methods for cervical ripening are associated with less uterine stimulation with a lower rate of tachysystole than prostaglandins. Therefore, these methods have been proposed as the optimal approach for late-onset FGR, since they could reduce the rate of cesarean sections for suspected fetal distress. However, there is no published randomized controlled trials on the use of different methods of cervical ripening for labor induction in late-onset FGR. Thus, the investigators postulate that, in late-onset FGR, cervical ripening with a mechanical method (Cook´s balloon) achieves a higher percentage of vaginal deliveries than a pharmacological method (vaginal dinoprostone), being safe for both the mother and the newborn. The main aim of this study is to evaluate whether cervical ripening with Cook balloon for labor induction at term gestation of singleton pregnancies with late-onset FGR achieves a higher rate of vaginal delivery compared to the use of vaginal dinoprostone, without increasing neonatal morbidity.

Conditions

• Fetal Growth Retardation

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-03-27
• Primary completion: 2025-05-23
• Completion: 2025-05-26
• First posted: 2023-03-17
• Last updated: 2025-06-11

Locations

5 sites across 1 country: Spain