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

NCT04560218 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2021-09-13

No results posted yet for this study

Summary

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

Conditions

  • To Compare Efficacy Intrauterine vs Sublingual MISOPROSTOL in Addition to Oxytocin in Reducing Blood Loss of Post-cesarean Section in High Risk Women

Interventions

DRUG

sublingual Misoprostol

apply drug by Anesthesiologist

DRUG

Intrauterine Misoprostol

apply drug by surgeon at uterine cornu

Sponsors & Collaborators

  • Department of Medical Services Ministry of Public Health of Thailand

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2021-07-31
Completion
2021-09-10

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04560218 on ClinicalTrials.gov