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

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

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560218
• Other study ID #: 122/2563
• Status: Completed
• Phase: Phase 3
• Start date: October 30, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: July 2021
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 10, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• =35 ??
• 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	total blood loss estimated by Anesthesiologist team	operation time
Secondary	Hemoglobin/Hematocrit change	compare before/after operation	until 24 hours post-operation
Secondary	need of uterotonic agents	number of uterotonic agents need and type of drug	until 24 hours post-operation
Secondary	need of blood transfusion	number of blood transfusion need	until 24 hours post-operation
Secondary	adverse drug event	adverse drug event of Misoprostol and Oxytocin	until 24 hours post-operation