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

Rajavithi Hospital

Status and phase: Completed; Phase 3

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

Treatments: Drug: sublingual Misoprostol; Drug: Intrauterine Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04560218

122/2563

Details and patient eligibility

About

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 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

Enrollment: 135 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups

Uterotonic agents group A

Experimental group

Description:

Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab

Treatment:

Drug: sublingual Misoprostol

Uterotonic agents group B

Experimental group

Description:

Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab

Treatment:

Drug: Intrauterine Misoprostol

Uterotonic agents group C

No Intervention group

Description:

Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab