The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

June 24, 2023 updated by: Ahmed M Maged, MD, Cairo University

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

  • Intaoperative blood loss
  • Risk of Postpartum hemorraghe in the first 24 hrs
  • HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

  • Intaoperative blood loss
  • Risk of Postpartum hemorraghe in the first 24 hrs
  • HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 12111
        • Kasr Alainy medical school

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 35 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

women attending for elective CS.

  • Age between 20-35 years.
  • Normal placental site
  • Normal coagulation profile
  • Full term pregnancies(above 37 wks)
  • Medically free
  • Spinal anesthesia
  • Living baby
  • Average liquor by U/S

Exclusion Criteria:

  • • Women attending for emergency CS

    • .age below 20 or above 35
    • Abnormal placentation (Placenta previa,accrete,increta or percreta)
    • Women with coagulopathy
    • Preterm pregnancies (before 37 wks)
    • Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
    • General anathesia
    • IUFD
    • Oligo or polyhydraminos by U/S

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: Routine ecbolic group
100 patients will receive routine ecbolics ( oxytocin) after delivery of baby
Procedure: cesarean section
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers
Drug: Oxytocin
10 IU of oxytocin with fetal delivery
Active Comparator: Misoprostol group
The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Procedure: cesarean section
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers
Drug: Oxytocin
10 IU of oxytocin with fetal delivery
Drug: Misoprostol
The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postpartum hemorrhage
Time Frame: 24 hours after cesarean section
24 hours after cesarean section

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ahmed maged, MD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 2, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 24, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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