NCT04560218

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

September 13, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

September 17, 2020

Last Update Submit

September 10, 2021

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    total blood loss estimated by Anesthesiologist team

    operation time

Secondary Outcomes (4)

  • Hemoglobin/Hematocrit change

    until 24 hours post-operation

  • need of uterotonic agents

    until 24 hours post-operation

  • need of blood transfusion

    until 24 hours post-operation

  • adverse drug event

    until 24 hours post-operation

Study Arms (3)

Uterotonic agents group A

EXPERIMENTAL

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

Drug: sublingual Misoprostol

Uterotonic agents group B

EXPERIMENTAL

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

Drug: Intrauterine Misoprostol

Uterotonic agents group C

NO INTERVENTION

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

Interventions

sublingual MisoprostolDRUG

apply drug by Anesthesiologist

Uterotonic agents group A
Intrauterine MisoprostolDRUG

apply drug by surgeon at uterine cornu

Uterotonic agents group B

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≥35 ปี
  • Previous PPH
  • Morbid obesity
  • Fetal macrosomia
  • Polyhydramnios
  • Induction/Augmentation of Labour
  • Prolonged Labour
  • Grand multiparity
  • Preeclampsia
  • Myoma Uteri

You may not qualify if:

  • Asthma
  • Maternal fever/ Tripple I can't excluded
  • coagulopathy
  • Placenta previa/ adherens/ abruptio placenta
  • Allergy to Prostaglandins/Oxytocin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2020

First Posted

September 23, 2020

Study Start

October 30, 2020

Primary Completion

July 31, 2021

Study Completion

September 10, 2021

Last Updated

September 13, 2021

Record last verified: 2021-07

Locations

TH(1)