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Completed

NCT Number: NCT02952807

Vaginal Misoprostol and Foley Catheter for Induction of Labor

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

Completed

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Key information

Conditions

Induction of Labor Affected Fetus / Newborn

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Zagazig University

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

vaginal Misoprostol Plus Foley Catheter

Other names: cytotec

foley catheter

Device

Primary outcomes

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

    Time frame: 48hours

    safety issue

Secondary outcomes

  1. Need of oxytocin for augmentation of labour

    Time frame: 48h

    safety issue

  2. Number of doses needed to bring on labour

    Time frame: 48h

    safety issue

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

    Time frame: 72h

    safety issue

  4. Hyperstimulation syndrome

    Time frame: 24h

    safety issue

  5. Cesarean section

    Time frame: 72h

    safety issue

  6. Severe neonatal morbidity or perinatal death

    Time frame: 28 days

    safety issue

  7. Serious maternal morbidity or maternal death

    Time frame: 42 days

    safety issue

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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