Labor, InducedCervical RipeningBalloon InductionMembrane StrippingPregnancy RelatedInduction of Birth
Investigational drug(s) / intervention(s)
Double Baloon CatheterMembrane StrippingPGE2
Double Baloon Catheter: A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study
Membrane Stripping: Stripping will be considered as 3-5 rotations of separating the amniotic sac from the cervix and will be perfomed twice (every 4-6 hours)
PGE2: A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours
Study summary
The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction.
The study population consists of women undergoing labor induction.
The main questions it aims to answer are:
1. Is membrane stripping as effective as double balloon catheter induction in cervical ripening?
2. What is the influence of membrane stripping on the time required for cervical ripening, delivery duration, and maternal and fetal outcomes compared to balloon induction.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Patients aged 18 and above
* Patients with a cervical dilation of at least 1 cm
* Full-term pregnancy
* Cephalic presentation
* No contraindication to vaginal delivery
Exclusion Criteria:
* Patients with rupture of membranes
* Patients who do not require cervical ripening and proceed directly to the delivery room for induction with oxytocin
* Patients for whom the use of a double-balloon catheter/PGE2 is contraindicated
* Twin pregnancies
* Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated
* Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress
Primary outcome measure(s)
Rates of successful cervical ripening at the end of 12 hours, duration of cervical ripening — from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months What percentage of the women in this arm had a successful cervical ripening after 12 hours
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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