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

• Status: Completed
• Trial end date: 2021-09-10
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rajavithi Hospital
• Treatments: Misoprostol

Criteria

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