Combined Method for Induction of Labor

NCT ID: NCT02685085

Last Updated: 2016-02-18

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together.

Detailed Description

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Conditions

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Induced Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Misoprostol

in this group misoprostol 25 ug will be administrated for induction of labor every 6 hours

Group Type EXPERIMENTAL

Misoprostol ( Prostaglandin E2)

Intervention Type DRUG

Foley's catheter

In this group foley's catheter 30 cc will be used for induction of labor

Group Type EXPERIMENTAL

Foley's catheter

Intervention Type DEVICE

Combined

Both misoprostol 25 ug and foley's catheter will be used for induction

Group Type EXPERIMENTAL

Misoprostol ( Prostaglandin E2)

Intervention Type DRUG

Foley's catheter

Intervention Type DEVICE

Interventions

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Misoprostol ( Prostaglandin E2)

Intervention Type DRUG

Foley's catheter

Intervention Type DEVICE

Other Intervention Names

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Cytotec

Eligibility Criteria

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Inclusion Criteria

* females presenting for induction of labor

Exclusion Criteria

* previous cesarean section
* previous uterine scars e.g. myomectomy
* refusal to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Refaat Dakhly

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina MR Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr el aini hospital

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dina MR Dakhly, MD

Role: CONTACT

01003498919 ext. 002

Facility Contacts

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Dina M Dakhly, MD

Role: primary

01003498919 ext. 002

Other Identifiers

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FM0702116

Identifier Type: -

Identifier Source: org_study_id

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