Prostaglandins Before Caserean Section

December 7, 2017 updated by: sarah mohamed hassan, Kasr El Aini Hospital

Does the Administration of Prostaglandins Before Cesarean Section Reduce the Amount of Blood Loss ?

The aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of blood loss

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

160 full term pregnant patients candidate for elective cesarean section were randomly allocated into 2 groups ,80 patients will receive 200mcg of rectal prostaglandins before cesarean section and 80 patients are used as control receiving placebo

Study Type

Interventional

Enrollment (Anticipated)

160

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
      • 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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:pregnant patients full term elective cesarean section

-

Exclusion Criteria:

  • medical disorder with pregnancy

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: Group A (Misoprostol group)
200 mcg rectal Misoprostol administration before cesarean section
Drug: Misoprostol 200Mcg Tab
administration of 200 Mcg of misoprotol rectal
Procedure: elective cesarean section
elective cesarean section for full term patients
Placebo Comparator: Group B (control group)
No prostaglandins administration before cesarean section
Procedure: elective cesarean section
elective cesarean section for full term patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of intraoperative blood loss
Time Frame: during cesarean section
number of soaked towels
during cesarean section
postpartum hemorrhage
Time Frame: 24 hour after cesarean section
blood loss after cesarean section
24 hour after cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetal condition
Time Frame: 5 minutes after cesarean section
apgar score
5 minutes after cesarean section

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

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)

December 1, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4122017

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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