Balloon Induction, Cervical Ripening, Induction of Birth, Labor, Induced, Membrane Stripping, Pregnancy Related
Conditions
Brief 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.
Interventions
DEVICEDouble Baloon Catheter
A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study
PROCEDUREMembrane 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)
DRUGPGE2
A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours
Sponsors
Meir Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of vaginal delivery within 24 hours | from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months | What percentage of the women in this arm delivered within 24 hours |
Countries
Israel
Contacts
CONTACTGal Cohen, MD
Outcome results
None listed