A placebo-controlled clinical trial to assess efficacy of tranexamic acid in reducing hemorrhage after vaginal delivery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201204079399N1

Enrollment

200

Registered

2012-11-15

Start date

2012-11-10

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postpartum hemorrhage. Haemorrhage following delivery of placenta

Interventions

Intervention 1: In the experimental group , 1gram of tranexamic acid diluted in 20ml Dextrose 5% will be administered intravenously soon after neonatal delivery. Blood pressure, pulse rate will be

Prevention

In the experimental group , 1gram of tranexamic acid diluted in 20ml Dextrose 5% will be administered intravenously soon after neonatal delivery. Blood pressure, pulse rate will be checked, 1 hour

In the control group , 20ml Dextrose 5% and placebo(normal saline) will be administered intravenously soon after neonatal delivery. Blood pressure, pulse rate will be checked, 1 hour and 2 hours

Eligibility

Sex/Gender

Female

Age

15 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1- inclusion criteria: - women with term, singleton pregnancy candidate for the first vaginal delivery -No history of sever medical complications involving the heart,brain ,kidney - No history of allergy to tranexamic acid -No history of visual problem -No history of sever pregnancy complications such as preeclampsia -No history of thromboembolic events 2- exclusion criteria: -patient avoidance -placenta abruption

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Hemoglobin. Timepoint: Before and 24 hours after delivery. Method of measurement: laboratory.;Maternal death. Timepoint: During 24 hours after delivery. Method of measurement: outcome form.	—

Secondary

Measure	Time frame
Blood transfusion. Timepoint: 24 hours after delivery. Method of measurement: outcome form.;Thromboembolic events in mother. Timepoint: 24 hours after delivery. Method of measurement: physical exam.;Surgical intervention. Timepoint: 24 hours after delivery. Method of measurement: outcome form.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Fereshteh Heidari Shirazi

Kashan University of Medical Sciences

heidarifereshteh@kaums.ac.ir+98 36 1555 0021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026