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

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

sublingual Misoprostol

Intrauterine Misoprostol

About this trial

This is an interventional prevention trial for To Compare Efficacy Intrauterine vs Sublingual MISOPROSTOL in Addition to Oxytocin in Reducing Blood Loss of Post-cesarean Section in High Risk Women focused on measuring Postpartum hemorrhage, Cesarean section, Sublingual Misoprostol, Intrauterine Misoprostol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Rajavithi hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Uterotonic agents group A

Uterotonic agents group B

Uterotonic agents group C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Blood loss

total blood loss estimated by Anesthesiologist team

Secondary Outcome Measures

Hemoglobin/Hematocrit change

compare before/after operation

need of uterotonic agents

number of uterotonic agents need and type of drug

need of blood transfusion

number of blood transfusion need

adverse drug event

adverse drug event of Misoprostol and Oxytocin

Full Information

NCT ID

NCT04560218

First Posted

September 17, 2020

Last Updated

September 10, 2021

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04560218

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 30, 2020 (Actual)

Primary Completion Date

July 31, 2021 (Actual)

Study Completion Date

September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Postpartum hemorrhage, Cesarean section, Sublingual Misoprostol, Intrauterine Misoprostol

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Uterotonic agents group A

Arm Type

Experimental

Arm Description

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

Arm Title

Uterotonic agents group B

Arm Type

Experimental

Arm Description

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

Arm Title

Uterotonic agents group C

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sublingual Misoprostol

Intervention Description

apply drug by Anesthesiologist

Intervention Type

Drug

Intervention Name(s)

Intrauterine Misoprostol

Intervention Description

apply drug by surgeon at uterine cornu

Primary Outcome Measure Information:

Title

Blood loss

Description

total blood loss estimated by Anesthesiologist team

Time Frame

operation time

Secondary Outcome Measure Information:

Title

Hemoglobin/Hematocrit change

Description

compare before/after operation

Time Frame

until 24 hours post-operation

Title

need of uterotonic agents

Description

number of uterotonic agents need and type of drug

Time Frame

until 24 hours post-operation

Title

need of blood transfusion

Description

number of blood transfusion need

Time Frame

until 24 hours post-operation

Title

adverse drug event

Description

adverse drug event of Misoprostol and Oxytocin

Time Frame

until 24 hours post-operation

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant women

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Rajavithi hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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