A Novel Protocol for Labour Induction

NCT ID: NCT01506388

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour

Conditions

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Failed Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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folye catheter plus vaginal IMN

intracervical foley catheter plus vaginal IMN

Group Type EXPERIMENTAL

foley catheter

Intervention Type DEVICE

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

Vaginal IMN

Intervention Type DRUG

IMN vaginal 40 mg every 4-6 hours

Misoprostol vaginally

intravaginal misoprostol

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

misoprostol 50 Ug , vaginally every 4-6 hours

Interventions

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foley catheter

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

Intervention Type DEVICE

Misoprostol

misoprostol 50 Ug , vaginally every 4-6 hours

Intervention Type DRUG

Vaginal IMN

IMN vaginal 40 mg every 4-6 hours

Intervention Type DRUG

Other Intervention Names

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misoprostol vaginally

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Waleed El-khayat

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed El-khayat, M.D.

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Waleed El-khayat

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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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)

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.

Reference Type DERIVED
PMID: 25694257 (View on PubMed)

Other Identifiers

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12012

Identifier Type: -

Identifier Source: org_study_id

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