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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2021

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

Interventions

  • Drug: sublingual Misoprostol
    • apply drug by Anesthesiologist
  • Drug: Intrauterine Misoprostol
    • apply drug by surgeon at uterine cornu

Arms, Groups and Cohorts

  • Experimental: Uterotonic agents group A
    • Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
  • Experimental: Uterotonic agents group B
    • Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
  • No Intervention: Uterotonic agents group C
    • Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab

Clinical Trial Outcome Measures

Primary Measures

  • Blood loss
    • Time Frame: operation time
    • total blood loss estimated by Anesthesiologist team

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Pregnant women

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.