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

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.

Timeline

Start

2023-03-27

Primary completion

2025-05-23

Completion

2025-05-26

Publications

• Herraiz I, Meler E, Mazarico E, Bonacina E, Blanco JE, Villalain C, Barbero P, Peguero A, Barbera A, Sanchez ML, Llorente Munoz I, Lora Pablos D, Figueras F, Galindo A. Cook's balloon versus dinoprostone for Labour induction of term pregnancies with fetal GROWth restriction: study protocol for a randomised controlled trial in tertiary maternity hospitals in Spain (COLIGROW study). BMJ Open. 2024 Sep 30;14(9):e089628. doi: 10.1136/bmjopen-2024-089628.

Drugs

Indications