Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

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

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Device: Transcervical Foley catheter; Drug: Misoprostol

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Ahmed Abass

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Transcervical Foley catheter; combined methods of induction of labor Floey Catheter with misoprstol; Drug: Misoprostol; Misoprstol inserted vaginally for induction of labor
ACTIVE_COMPARATOR: 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.	Drug: Misoprostol; Misoprstol inserted vaginally for induction of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
induction delivery time	time elapsed from start of induction till delivery of the baby	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
misoprstol dose	total misoprstol needed in each group	24 hours
induction active stage time	time elapsed from induction of labor till reaching 6 cm cervical dialtation	24 hours
Mode of delivery	mode od delivery either vaginal or Caesarian Section	48 hours
Maternal Pyrexia	fever (Temp > 37.8 ) any time during labor	48 hours
hypersystole	one uterine contraction with duration of more than 90 sec.	48 hours
Tachysystole	Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities.	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Apgar score	Neonatal Apgar score	1 min after delivery
Neonatal Apgar score	Neonatal Apgar score	5 min after delivery
Neonatal birth weight	Neonatal birth weight	10 min after delivery
neonatal ICU admission	Number of neonates in need for ICU admission	2 hours after delivery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (ACTUAL): September 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: misoprostol , intracervical Foley catheter , induction of labor , term pregnancy.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: ase36278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No