NCT02952807

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

June 16, 2017

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 31, 2016

Last Update Submit

June 14, 2017

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

  • induction delivery interval (time from starting induction to delivery)

    safety issue

    48hours

Secondary Outcomes (7)

  • Need of oxytocin for augmentation of labour

    48h

  • Number of doses needed to bring on labour

    48h

  • Failed induction (failure to elicit contraction after 72 hours)

    72h

  • Hyperstimulation syndrome

    24h

  • Cesarean section

    72h

  • +2 more secondary outcomes

Study Arms (2)

sequential

ACTIVE COMPARATOR

sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.

Drug: MisoprostolDevice: Foley Catheter

Concurrent

ACTIVE COMPARATOR

Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.

Drug: MisoprostolDevice: Foley Catheter

Interventions

MisoprostolDRUG

vaginal Misoprostol Plus Foley Catheter

Also known as: cytotec
Concurrentsequential
Foley CatheterDEVICE
Concurrentsequential

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Indication for labour induction Term pregnancy with alive fetus Bishop score less than five

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, 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 Officials

  • ibrahim A el sharkwy, MD

    FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

June 16, 2017

Record last verified: 2016-11

Locations

EG(1)