Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

NCT03870256 | Completed DMC

• 1 other identifier: aswu/200/19
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Conditions

Post Partum Hemorrhage

Keywords

Postpartum Hemorrhage; vaginal delivery; tranexamic acid; misoprostol

Outcome Measures

Primary Outcomes (1)

• the amount of blood loss

  the amount of blood loss by gm calculated by gravimetric methods

  6 hours post delivery

Secondary Outcomes (2)

• number of patients loss more than 1000 ml blood

  24 hours post delivery

• need of uterotonics

  24 hours post delivery

Study Arms (2)

TA plus misoprostol

ACTIVE COMPARATOR

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

Drug: misoprostol; Drug: TA

Carbetocin

ACTIVE COMPARATOR

Patient receives 100 mic gm carbetocin IV

Drug: Carbetocin

Interventions

misoprostol DRUG

Patient receive 600mic gm sublingual misoprostol

Also known as: Active comparator

TA plus misoprostol

Carbetocin DRUG

Patient receive 100 mic gm carbetocin IV

Also known as: Active Comparator

Carbetocin

TA DRUG

The patient receives 1gm oral tranexamic acid

Also known as: Active Comparator

TA plus misoprostol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: All participants had PPH defined as vaginal bleeding\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

AswanUH

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• hany f allam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was a prospective double-blind randomized study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: This study was a prospective double-blind randomized study

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)