Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT

September 10, 2021 updated by: Rajavithi Hospital

Sublingual Versus Intrauterine MISOPROSTOL in Addition to Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Randomized Placebo Controlled Trial

Research Objective:

Primary outcome

-To compare efficacy Intrauterine vs Sublingual MISOPROSTOL in addition to Oxytocin in reducing blood loss of post-cesarean section in high risk women

Secondary outcome

-To study Hemoglobin/Hematocrit change, need of uterotonic agents, need of blood transfusion, adverse drug event of Intrauterine vs Sublingual Misoprostol plus Oxytocin compare to Oxytocin alone

Hypothesis:

-Intrauterine MISOPROSTOL plus Oxytocin is not inferior to Sublingual MISOPROSTOL plus Oxytocin in reducing blood loss of post-cesarean section in high risk women

Study Overview

Detailed Description

Research Design: Double-blind Randomized Placebo Controlled Trial

Subject: Singleton pregnancy GA 34 wk or more with high risk for postpartum hemorrhage undergo cesarean section with spinal anesthesia in Rajavithi Hospital

Allocated to 3 groups

  • group1: Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
  • group2: Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
  • group3: Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab

Study Type

Interventional

Enrollment (Actual)

135

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

      • Bangkok, Thailand, 10400
        • Rajavithi 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ≥35 ปี
  • Previous PPH
  • Morbid obesity
  • Fetal macrosomia
  • Polyhydramnios
  • Induction/Augmentation of Labour
  • Prolonged Labour
  • Grand multiparity
  • Preeclampsia
  • Myoma Uteri

Exclusion Criteria:

  • Asthma
  • Maternal fever/ Tripple I can't excluded
  • coagulopathy
  • Placenta previa/ adherens/ abruptio placenta
  • Allergy to Prostaglandins/Oxytocin

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: Uterotonic agents group A
Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
apply drug by Anesthesiologist
Experimental: Uterotonic agents group B
Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
apply drug by surgeon at uterine cornu
No Intervention: Uterotonic agents group C
Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: operation time
total blood loss estimated by Anesthesiologist team
operation time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin/Hematocrit change
Time Frame: until 24 hours post-operation
compare before/after operation
until 24 hours post-operation
need of uterotonic agents
Time Frame: until 24 hours post-operation
number of uterotonic agents need and type of drug
until 24 hours post-operation
need of blood transfusion
Time Frame: until 24 hours post-operation
number of blood transfusion need
until 24 hours post-operation
adverse drug event
Time Frame: until 24 hours post-operation
adverse drug event of Misoprostol and Oxytocin
until 24 hours post-operation

Collaborators and Investigators

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

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)

October 30, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

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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