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Completed

NCT Number: NCT03682718

Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Abass

Cairo, 11311, Egypt

About this study

Cervical status is a good predictor of the likelihood of vaginal delivery when labor is induced. Any induction method is likely to be effective in a woman with a favorable cervix, whereas no method is highly successful when performed in a woman with a cervix that is unfavorable.

The use of a balloon catheter as induction method was first described in 1862 by Trainer. The goal of the catheter was to ripen the cervix through direct mechanical dilatation of the cervical canal and indirectly by increasing endogenous prostaglandin secretion.

Alternatively, Prostaglandins are one of the key players in cervical ripening by a number of different mechanisms.

The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Singleton pregnancy Gestational age ≥ 37 weeks (calculated from reliable menstrual dates and/or late first trimester or early second trimester ultrasound) Modified Bishop Score ≥ 5 Valid indication for induction of labor Intact fetal membranes Normal fetal non-stress test cervical dilation less than or equal to 2cm vertex presentation

Exclusion criteria

Any contraindication for vaginal delivery (e.g. placenta Previa, accrete ) Any contraindication for induction of labor (e.g. fetal malpersentation, prior uterine surgery) Active labor Antepartum hemorrhage Eclampsia Patients with hemolysis, elevated liver enzymes and low platelets Suspected chorioamnitis Intrauterine growth retardation Multiple gestation Non-reassuring fetal heart rate Continuous contractions more than 3 times in 10 minutes at onset of induction of labor Intrauterine fetal demise Any contraindication for use of misoprostol (e.g. bronchial asthma, drug allergy, History of glaucoma) Any contraindication for use of Foley catheter (already ripped cervix) Rupture of membranes Not consenting

Treatment and study plan

Transcervical Foley Catheter

Device

combined methods of induction of labor Floey Catheter with misoprstol

Misoprostol

Drug

Misoprstol inserted vaginally for induction of labor

Primary outcomes

  1. induction delivery time

    Time frame: 48 hours

    time elapsed from start of induction till delivery of the baby

Secondary outcomes

  1. misoprstol dose

    Time frame: 24 hours

    total misoprstol needed in each group

  2. induction active stage time

    Time frame: 24 hours

    time elapsed from induction of labor till reaching 6 cm cervical dialtation

  3. Mode of delivery

    Time frame: 48 hours

    mode od delivery either vaginal or Caesarian Section

  4. Maternal Pyrexia

    Time frame: 48 hours

    fever (Temp > 37.8 ) any time during labor

  5. hypersystole

    Time frame: 48 hours

    one uterine contraction with duration of more than 90 sec.

  6. Tachysystole

    Time frame: 48 hours

    Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities.

Other outcomes

  1. Neonatal Apgar score

    Time frame: 1 min after delivery

    Neonatal Apgar score

  2. Neonatal Apgar score

    Time frame: 5 min after delivery

    Neonatal Apgar score

  3. Neonatal birth weight

    Time frame: 10 min after delivery

    Neonatal birth weight

  4. neonatal ICU admission

    Time frame: 2 hours after delivery

    Number of neonates in need for ICU admission

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Vaginal Misoprostol With Intracervical Foley Catheter Versus Vaginal Misoprostol Alone in Induction of Labor at Term Pregnancy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2018
Registry last updated
Jan 20, 2021

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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