Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy

NCT ID: NCT02989324

Last Updated: 2018-02-07

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

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-11-30

Brief Summary

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Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Detailed Description

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this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.

Conditions

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Late Second Trimester Termination of Pregnancy

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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Vaginal Misoprosto

Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section

Group Type EXPERIMENTAL

MisoprostoL

Intervention Type DRUG

Vaginal MisoprostoL

Misoprostol Plus Foley Catheter

Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Group Type ACTIVE_COMPARATOR

MisoprostoL

Intervention Type DRUG

Vaginal MisoprostoL

Foley Catheter

Intervention Type DEVICE

Misoprostol Plus Foley Catheter

Interventions

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MisoprostoL

Vaginal MisoprostoL

Intervention Type DRUG

Foley Catheter

Misoprostol Plus Foley Catheter

Intervention Type DEVICE

Other Intervention Names

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CYTOTEC

Eligibility Criteria

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Inclusion Criteria

* IUFD
* Previous Multiple Cesarean Sections

Exclusion Criteria

* asthma
* allergy to misoprostol
* patient refuse to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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IBRAHIM ABD ELGAFOR

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ibrahim A el sharkwy, MD

Role: PRINCIPAL_INVESTIGATOR

FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

Locations

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Zagazig University

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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zuh- 4

Identifier Type: -

Identifier Source: org_study_id

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