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

November 9, 2016 updated by: Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt
        • Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: misoprostol
women receiving pre-operative rectally administered 400 microgram misoprostol
Drug: misoprostol
400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section
Other Names:
  • mesotac
Active Comparator: placeboo
women receiving placebo
Drug: placeboo
women will recive 2 identical tablets as placeboo
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of intraoperative blood loss
Time Frame: 30 minute
volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor
30 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal mortality
Time Frame: 6 months
6 months
mean measured blood loss
Time Frame: 1, 2, and 24 h postpartum
1, 2, and 24 h postpartum
placental retention
Time Frame: 30 minutes
when the placenta is not delivered spontaneously for 30 minutes
30 minutes
requirement for blood transfusion
Time Frame: 24 hours
indicated per clinical protocol at the study site for mothers with a hemoglobin <100 g/l and/or severe pallor
24 hours
requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures
Time Frame: 24 hours
24 hours
postpartum hemoglobin
Time Frame: 24 hours
less than 10gm%
24 hours
mean postpartum hematocrit
Time Frame: 24 hours
more than 10% drop in the postpartum hematocrit
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Helmy Dr metawe, MD, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POMCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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