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CompletedNCT02952807Updated Jun 16, 2017

Vaginal Misoprostol and Foley Catheter for Induction of Labor

A Phase 2 interventional study of Misoprostol and Foley Catheter in Induction of Labor Affected Fetus / Newborn, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-16.

Sponsored by Zagazig University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Induction of Labor Affected Fetus / Newborn
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Active comparator
    sequential

    sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.

    Drug: Misoprostol · Device: Foley Catheter

  • Active comparator
    Concurrent

    Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.

    Drug: Misoprostol · Device: Foley Catheter

Interventions

  • DrugMisoprostol

    vaginal Misoprostol Plus Foley Catheter

    Also known as: cytotec

  • DeviceFoley Catheter
06

What researchers measure

Primary outcomes

  1. induction delivery interval (time from starting induction to delivery)

    safety issue

    Time frame: 48hours

Secondary outcomes

  1. Need of oxytocin for augmentation of labour

    safety issue

    Time frame: 48h

  2. Number of doses needed to bring on labour

    safety issue

    Time frame: 48h

  3. Failed induction (failure to elicit contraction after 72 hours)

    safety issue

    Time frame: 72h

  4. Hyperstimulation syndrome

    safety issue

    Time frame: 24h

  5. Cesarean section

    safety issue

    Time frame: 72h

  6. Severe neonatal morbidity or perinatal death

    safety issue

    Time frame: 28 days

  7. Serious maternal morbidity or maternal death

    safety issue

    Time frame: 42 days

07

Study locations

1 site
  • Zagazig University
    Zagazig, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02952807
Lead sponsor
Zagazig University
Responsible party
IBRAHIM ABD ELGAFOR (assistant lecturer, Zagazig University) — Principal investigator
First posted
Nov 2, 2016
Start date
Jan 2016
Primary completion
Jan 2017
Completion
Feb 2017
Last update
Jun 16, 2017

Study contacts

ibrahim A el sharkwy, MD
principal investigator · FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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