Vaginal Misoprostol and Foley Catheter for Induction of Labor

Overview

to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor

Full Title of Study: “Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

Detailed Description

two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.

Interventions

  • Drug: Misoprostol
    • vaginal Misoprostol Plus Foley Catheter
  • Device: Foley Catheter

Arms, Groups and Cohorts

  • Active Comparator: sequential
    • sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.
  • Active Comparator: Concurrent
    • Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.

Clinical Trial Outcome Measures

Primary Measures

  • induction delivery interval (time from starting induction to delivery)
    • Time Frame: 48hours
    • safety issue

Secondary Measures

  • Need of oxytocin for augmentation of labour
    • Time Frame: 48h
    • safety issue
  • Number of doses needed to bring on labour
    • Time Frame: 48h
    • safety issue
  • Failed induction (failure to elicit contraction after 72 hours)
    • Time Frame: 72h
    • safety issue
  • Hyperstimulation syndrome
    • Time Frame: 24h
    • safety issue
  • Cesarean section
    • Time Frame: 72h
    • safety issue
  • Severe neonatal morbidity or perinatal death
    • Time Frame: 28 days
    • safety issue
  • Serious maternal morbidity or maternal death
    • Time Frame: 42 days
    • safety issue

Participating in This Clinical Trial

Inclusion Criteria

  • Indication for labour induction Term pregnancy with alive fetus Bishop score less than five Exclusion Criteria:

  • Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Zagazig University
  • Provider of Information About this Clinical Study
    • Principal Investigator: IBRAHIM ABD ELGAFOR, assistant lecturer – Zagazig University
  • Overall Official(s)
    • ibrahim A el sharkwy, MD, Principal Investigator, FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

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