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

Phase 3

Completed

• 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: Intrauterine Misoprostol; Drug: sublingual Misoprostol

• Registration Number: NCT04560218
• Lead Sponsor: Rajavithi Hospital

Brief 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

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 Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-10-30
• Status Verified: 2021-07
• Primary Completion: 2021-07-31
• Study Completion: 2021-09-10
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uterotonic agents group B	Intrauterine Misoprostol	Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
Uterotonic agents group A	sublingual Misoprostol	Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab

Primary Outcome Measures

Name	Time	Method
Blood loss	operation time	total blood loss estimated by Anesthesiologist team

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Bangkok, Thailand