NCT01506388

Brief Summary

The use of foley catheter was tested many times and proved to be effective for induction of labour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

2 active sites

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

January 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

January 4, 2012

Last Update Submit

January 19, 2014

Conditions

Failed Induction of Labor

Keywords

labour inductionFoley cathetermisoprostolisosorbide mononitrate

Outcome Measures

Primary Outcomes (1)

  • caesarean section rate

    caesarean section

    1 year

Secondary Outcomes (1)

  • time from induction to delivery

    1 year

Study Arms (2)

folye catheter plus vaginal IMN

EXPERIMENTAL

intracervical foley catheter plus vaginal IMN

Device: foley catheterDrug: Vaginal IMN

Misoprostol vaginally

ACTIVE COMPARATOR

intravaginal misoprostol

Drug: Misoprostol

Interventions

foley catheterDEVICE

foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours

folye catheter plus vaginal IMN
MisoprostolDRUG

misoprostol 50 Ug , vaginally every 4-6 hours

Also known as: misoprostol vaginally
Misoprostol vaginally
Vaginal IMNDRUG

IMN vaginal 40 mg every 4-6 hours

folye catheter plus vaginal IMN

Eligibility Criteria

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

You may qualify if:

  • Term or post term pregnancies.
  • Live,singleton fetus.
  • Cephalic presentation.
  • Intact membrane.
  • Bishop score \< 6.
  • Not in labour.
  • Medically indicated for labour induction.
  • Primigravida or parity of 3 or less.

You may not qualify if:

  • Previous caesarean delivery.
  • Malpresentation.
  • Placenta previa.
  • Sever intrauterine growth restriction.
  • Multiple pregnancy.
  • Polyhydramnios.
  • Oligohydramnios.
  • Bishop score 7 or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Cairo, Cairo Governorate, 12211, Egypt

Location

Waleed El-khayat

Cairo, Cairo Governorate, 12211, Egypt

Location

Related Publications (2)

  • 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

  • El-Khayat W, Alelaiw H, El-kateb A, Elsemary A. Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction. J Matern Fetal Neonatal Med. 2016;29(3):487-92. doi: 10.3109/14767058.2015.1007036. Epub 2015 Feb 19.

    PMID: 25694257DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Waleed El-khayat, M.D.

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 10, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

EG(2)