Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

NCT ID: NCT03682718

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-02-01

Brief Summary

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.

Detailed Description

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.

Conditions

Induction of Labor Affected Fetus / Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

vaginal misoprostol and intracervical Foley catheter

participants will receive misoprostol by the same dose and method. Transcervical Foley catheter (size 16F, with 30ml balloon capacity) will be passed. The catheter will deflated, removed and cervix re-assessed if no spontaneous expulsion occurred at 12 hours post- insertion. A new catheter will be passed for another 12 hours, if the Bishop score is less than 8 this will be considered as failure of induction.

Group Type: EXPERIMENTAL

Transcervical Foley catheter

Intervention Type: DEVICE

combined methods of induction of labor Floey Catheter with misoprstol

Misoprostol

Intervention Type: DRUG

Misoprstol inserted vaginally for induction of labor

vaginal misoprostol

Misoprostol group; participants will receive 50 μg intravaginal in the posterior vaginal fornix, 25 μg will be given every 4 hours for another two doses, if a satisfactory Bishop score of 8 not reached, patient will take an overnight rest and she will continue induction by the same doses on the next day-provided that there is no ROMs- (this is according to Ain Shams University Protocol) The maximum dose of Misoprostol is 200 μg.

Oxytocin infusion will not started until 6 hours after the last dose or if there is no adequate contractions obtained.

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Misoprstol inserted vaginally for induction of labor

Interventions

Transcervical Foley catheter

combined methods of induction of labor Floey Catheter with misoprstol

Intervention Type: DEVICE

Misoprostol

Misoprstol inserted vaginally for induction of labor

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abass

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abass

Cairo, , Egypt

Countries

Egypt

References

de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type: DERIVED

PMID: 36996264 (View on PubMed)

Other Identifiers

ase36278

Identifier Type: -

Identifier Source: org_study_id