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Completed

NCT Number: NCT04560218

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

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

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Key information

Conditions

To Compare Efficacy Intrauterine vs Sublingual MISOPROSTOL in Addition to Oxytocin in Reducing Blood Loss of Post-cesarean Section in High Risk Women Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Rajavithi hospital

Bangkok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublingual misoprostol

Drug

apply drug by Anesthesiologist

Intrauterine Misoprostol

Drug

apply drug by surgeon at uterine cornu

Primary outcomes

  1. Blood loss

    Time frame: operation time

    total blood loss estimated by Anesthesiologist team

Secondary outcomes

  1. Hemoglobin/Hematocrit change

    Time frame: until 24 hours post-operation

    compare before/after operation

  2. need of uterotonic agents

    Time frame: until 24 hours post-operation

    number of uterotonic agents need and type of drug

  3. need of blood transfusion

    Time frame: until 24 hours post-operation

    number of blood transfusion need

  4. adverse drug event

    Time frame: until 24 hours post-operation

    adverse drug event of Misoprostol and Oxytocin

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2020
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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