NCT03682718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

September 21, 2018

Last Update Submit

January 16, 2021

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

misoprostol , intracervical Foley catheter , induction of labor , term pregnancy.

Outcome Measures

Primary Outcomes (1)

  • induction delivery time

    time elapsed from start of induction till delivery of the baby

    48 hours

Secondary Outcomes (6)

  • misoprstol dose

    24 hours

  • induction active stage time

    24 hours

  • Mode of delivery

    48 hours

  • Maternal Pyrexia

    48 hours

  • hypersystole

    48 hours

  • +1 more secondary outcomes

Other Outcomes (4)

  • Neonatal Apgar score

    1 min after delivery

  • Neonatal Apgar score

    5 min after delivery

  • Neonatal birth weight

    10 min after delivery

  • +1 more other outcomes

Study Arms (2)

vaginal misoprostol and intracervical Foley catheter

EXPERIMENTAL

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 catheterDrug: Misoprostol

vaginal misoprostol

ACTIVE COMPARATOR

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

Interventions

Transcervical Foley catheterDEVICE

combined methods of induction of labor Floey Catheter with misoprstol

vaginal misoprostol and intracervical Foley catheter
MisoprostolDRUG

Misoprstol inserted vaginally for induction of labor

vaginal misoprostolvaginal misoprostol and intracervical Foley catheter

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abass

Cairo, 11311, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 36996264DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

October 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

EG(1)