The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

February 24, 2014 updated by: Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

618

Phase

  • Phase 4

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 44 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. live and singleton pregnancy
  2. Elective caesarean
  3. Gestational week greater than 37 weeks
  4. patient between 18-44 year old

Exclusion Criteria:

  1. -multiple pregnancy
  2. Preeclampsia
  3. Gestational diabetes
  4. Macrosomia
  5. Oligohidraamnıos
  6. Polihidraamnıos
  7. Myoma
  8. Morbid obesity
  9. Coagulatıon defect (such as HELLP syndrome)

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: sublingual
400 microgram mısoprostol will be administered sublıngually before elective caesarean
Drug: Misoprostol
PLACEBO_COMPARATOR: rectal
rectal 600 mgr misoprostol will be administered
Drug: Misoprostol
NO_INTERVENTION: synpitan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postpartum Haemorrhage
Time Frame: postpartum 24 hour
postpartum 24 hour

Collaborators and Investigators

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

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Investigators

  • Principal Investigator: Berhan AŞICIOĞLU, M.D., T.C.S.B. Kanuni Sultan Süleyman Research 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

June 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (ESTIMATE)

August 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aşıcıoğlu-05

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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