NCT03777696

Brief Summary

Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent cesarean section

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

December 14, 2018

Last Update Submit

February 14, 2019

Conditions

Cesarean Section Complications

Keywords

cesarean sectiontranexamic acidpostpartum hemorrhagemisoprostol

Outcome Measures

Primary Outcomes (1)

  • estimation of intraoperative blood loss (ml)

    measure Intraoperative blood loss in ml by gravimetric methods

    during the operation

Secondary Outcomes (2)

  • amount of postoperative blood loss

    6 hours post operative

  • number of patient with postpartum hemorrhage

    24 hours post operative

Study Arms (3)

Misoprostol with TA

ACTIVE COMPARATOR

400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout

Drug: MisoprostolDrug: TA

Misoprostol with placebo to TA

ACTIVE COMPARATOR

400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout

Drug: MisoprostolDrug: placebo to TA

placebo to Misoprostol and TA

PLACEBO COMPARATOR

placebo to misoprostol plus placebo to tranexamic acid

Drug: TADrug: placebo to misoprostol

Interventions

MisoprostolDRUG

400 μg of buccal misoprostol

Also known as: Active Comparator
Misoprostol with TAMisoprostol with placebo to TA
TADRUG

1 gm of tranexamic acid in 100 ml saline iv

Also known as: active comparator
Misoprostol with TAplacebo to Misoprostol and TA
placebo to misoprostolDRUG

placebo tablets to misoprostol buccal

Also known as: Placebo comparator
placebo to Misoprostol and TA
placebo to TADRUG

110 ml saline iv

Also known as: placebo comparator
Misoprostol with placebo to TA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsage \>18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age \>18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor

You may not qualify if:

  • multiple gestations
  • placenta praevia and placental abruption
  • undergoing cesarean section with general anesthesia
  • women undergoing cesarean section at less than 37 weeks of gestation--with a severe medical disorder
  • allergy to tranexamic acid or misoprostol
  • refuse to consent
  • elective cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

01022336052hany.farouk@aswu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
a double-blinded randomized placebo-controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Double-Blind Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 17, 2018

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

EG(1)