Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

NCT ID: NCT02509351

Last Updated: 2016-11-10

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/PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-11-30

Brief Summary

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* Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
* The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin

Detailed Description

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Research question:

In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?

Research hypothesis:

pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section

Conditions

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Postpartum Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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misoprostol

women receiving pre-operative rectally administered 400 microgram misoprostol

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section

placeboo

women receiving placebo

Group Type ACTIVE_COMPARATOR

placeboo

Intervention Type DRUG

women will recive 2 identical tablets as placeboo

Interventions

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misoprostol

400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section

Intervention Type DRUG

placeboo

women will recive 2 identical tablets as placeboo

Intervention Type DRUG

Other Intervention Names

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mesotac control

Eligibility Criteria

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Inclusion Criteria

* 38-41 weeks of amenorrhea
* scheduled for elective lower segment cesarean section

Exclusion Criteria

* confirmed intrauterine fetal death
* more than previous 2 ceserean sections
* multiple pregnancy
* antepartum haemorrhage
* self-reported maternal heart disease
* current diagnosis of severe malaria or acute bacterial infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed El Kotb Abdel Fattah

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helmy Dr metawe, MD

Role: STUDY_CHAIR

Ain Shams University

Locations

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Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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POMCS

Identifier Type: -

Identifier Source: org_study_id