RecruitingNot ApplicableNCT06591247

Membrane Stripping for Cervical Ripening

Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study


Sponsor

Meir Medical Center

Enrollment

200 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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 is contraindicated
  • Twin pregnancies
  • Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated
  • Vaginal deliveries after a cesarean section
  • Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress

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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)


Locations(1)

Meir Medical Center

Kfar Saba, Central District, Israel

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NCT06591247


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