Health TrialsbyHealthPanel

Membrane Stripping for Cervical Ripening

ConditionsLabor, InducedCervical RipeningBalloon InductionMembrane StrippingPregnancy RelatedInduction of Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMeir Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged 18 and above

Patients with a cervical dilation of at least 1 cm

Full-term pregnancy

Cephalic presentation

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Double Baloon Catheter

    Device

    A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study

  • Membrane Stripping

    Procedure/Surgery

    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

    Drug

    A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Double Balloon Catheter inductionActive comparator 1 intervention
Group B: Membrane strippingActive comparator 1 intervention
Group C: PGE2 inductionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rates of successful cervical ripening at the end of 12 hours, duration of cervical ripening

What percentage of the women in this arm had a successful cervical ripening after 12 hours

Time frame
from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months

Secondary outcomes

1

Rates of vaginal delivery within 24 hours

What percentage of the women in this arm delivered within 24 hours

Time frame
from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meir Medical Center

Lead sponsor

Source ClinicalTrials.gov
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