NCT03774706

Brief Summary

Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic 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
150

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 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

December 11, 2018

Last Update Submit

February 14, 2019

Conditions

Cesarean Section Complications

Keywords

cesarean sectiontranexamic acidmisoprostol

Outcome Measures

Primary Outcomes (1)

  • number of patients develop postpartum hemorrhage

    calculation of number of patients develop postpartum hemorrhage

    6 hours post operative

Secondary Outcomes (1)

  • intraoperative blood loss (ml)

    during the operation

Other Outcomes (2)

  • postoperative blood loss (ml)

    6 hours post operative

  • number of patients need blood transfusion

    24 hours postoperative

Study Arms (2)

Misoprostol with TA

ACTIVE COMPARATOR

two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv

Drug: MisoprostolDrug: Tranexamic Acid

Misoprostol with placebo to TA

ACTIVE COMPARATOR

two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv

Drug: MisoprostolDrug: placebo to tranexamic acid

Interventions

MisoprostolDRUG

two tablets misoprostol 400 μg sublingual

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

two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline

Also known as: active comparator
Misoprostol with TA
placebo to tranexamic acidDRUG

placebo to tranexamic acid (110 ml saline)

Also known as: Placebo
Misoprostol with placebo to TA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who undergo elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
  • age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia.

You may not qualify if:

  • having an underlying disease (heart, liver, kidney, pulmonary, etc.),
  • eclampsia and severe preeclampsia
  • allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol
  • coagulation disorders
  • refuse or unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Interventions

MisoprostolTranexamic Acid

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam

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
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: double-blind placebo randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 13, 2018

Study Start

January 1, 2019

Primary Completion

December 30, 2021

Study Completion

January 31, 2022

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

EG(1)