Misoprostol Before and After Cesarean Section

March 12, 2018 updated by: sarah mohamed hassan

The Effect of Misoprostol Given Preoperative Versus Postoperative on Blood Loss With Elective Cesarean Section: Randomized Controlled Trial

comparison of the effect of misoprostol before and after cesarean on the blood loss

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

70 women who received 600 mg misoprostol rectally preoperatively versus 70 women who received 600 mg misoprostol postoperatively at operating theatre

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • 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
      • Cairo, Egypt, 11562
        • Kasr El Ainiy Hospital

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 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women not in active labor have reactive non-stress test.
  • No contraindications to prostaglandins.
  • Have no history of coagulopathy.

Exclusion Criteria:

  • Placenta previa.
  • Maternal hypertension.
  • Diabetes mellitus.
  • Previous CS and those with active labor.
  • Multiple Fibroid uterus.
  • Multiple pregnancies or polyhydramnios.
  • Previous myomectomy, previous history of PPH.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: preoperative misoprostol group
70 women who received 600 mg misoprostol rectally preoperatively before cesarean section
Drug: rectal misoprostol 600mg
70 women who received 600 mg misoprostol postoperatively at operating theatre
Active Comparator: postoperative misoprostol group
70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section
Drug: rectal misoprostol 600mg
70 women who received 600 mg misoprostol postoperatively at operating theatre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: the operation time
Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)
the operation time
postoperative blood loss
Time Frame: every 6 hours during first 24 hours.
weighing the soaked napkins after collection of soaked towel
every 6 hours during first 24 hours.

Collaborators and Investigators

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

Sponsor

sarah mohamed hassan

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 (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 4, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1122345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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