Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction
Status:
Not yet recruiting
Trial end date:
2025-09-27
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Hospital Universitario 12 de Octubre
Collaborators:
Instituto de Salud Carlos III Spanish Clinical Research Network - SCReN