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Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

Primary Purpose

Post Partum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
misoprostol
Carbetocin
TA
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Hemorrhage focused on measuring Postpartum Hemorrhage, vaginal delivery, tranexamic acid, misoprostol

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.

Exclusion Criteria:

  • were gestational age<37 weeks,
  • genital tract trauma,
  • coagulation defect,
  • women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
  • known hypersensitivity to carbetocin or oxytocin.

Sites / Locations

  • AswanUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TA plus misoprostol

Carbetocin

Arm Description

Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm

Patient receives 100 mic gm carbetocin IV

Outcomes

Primary Outcome Measures

the amount of blood loss
the amount of blood loss by gm calculated by gravimetric methods

Secondary Outcome Measures

number of patients loss more than 1000 ml blood
calculate number of patients loss more than 1000 ml blood
need of uterotonics
number of patients need of uterotonics

Full Information

First Posted
March 8, 2019
Last Updated
September 27, 2021
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03870256
Brief Title
Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage
Official Title
The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery
Detailed Description
Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
Keywords
Postpartum Hemorrhage, vaginal delivery, tranexamic acid, misoprostol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was a prospective double-blind randomized study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study was a prospective double-blind randomized study
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA plus misoprostol
Arm Type
Active Comparator
Arm Description
Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm
Arm Title
Carbetocin
Arm Type
Active Comparator
Arm Description
Patient receives 100 mic gm carbetocin IV
Intervention Type
Drug
Intervention Name(s)
misoprostol
Other Intervention Name(s)
Active comparator
Intervention Description
Patient receive 600mic gm sublingual misoprostol
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Active Comparator
Intervention Description
Patient receive 100 mic gm carbetocin IV
Intervention Type
Drug
Intervention Name(s)
TA
Other Intervention Name(s)
Active Comparator
Intervention Description
The patient receives 1gm oral tranexamic acid
Primary Outcome Measure Information:
Title
the amount of blood loss
Description
the amount of blood loss by gm calculated by gravimetric methods
Time Frame
6 hours post delivery
Secondary Outcome Measure Information:
Title
number of patients loss more than 1000 ml blood
Description
calculate number of patients loss more than 1000 ml blood
Time Frame
24 hours post delivery
Title
need of uterotonics
Description
number of patients need of uterotonics
Time Frame
24 hours post delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation. Exclusion Criteria: were gestational age<37 weeks, genital tract trauma, coagulation defect, women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy known hypersensitivity to carbetocin or oxytocin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f allam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AswanUH
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

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