MedTrace Logo

Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Cesarean Section in Primigravida

NCT04635007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-07-22

No results posted yet for this study

Summary

The aim of the work is to compare the efficacy of preoperative IV tranexamic acid and rectal misoprostol in reducing blood loss in the elective cesarean section.

Research question:

In women undergoing elective cesarean section, is preoperative administration of IV tranexamic acid better than rectal misoprostol in reducing blood loss?

Conditions

  • Cesarean Section Complications
  • Blood Loss, Surgical
  • Misoprostol
  • Tranexamic Acid

Interventions

DRUG

Tranexamic acid

100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally.

DRUG

Misoprostol 200mcg Tab

100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohammed A Taymour, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-06-01
Completion
2022-06-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635007 on ClinicalTrials.gov