MedDataX Logo

Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women

NCT ID: NCT04201951

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.

A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage High Risk Pregnancy Tranexamic Acid Third-Stage Postpartum Hemorrhage, With Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
All providers and delivered women will be blinded for the content of the bags which will be applied for women randomly

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tranexamic group

Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Glucose water 5%

Intervention Type OTHER

Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Placebo group

Group B will receive 30ML 5% glucose water

Group Type PLACEBO_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Glucose water 5%

Intervention Type OTHER

Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic acid injection

Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Intervention Type DRUG

Glucose water 5%

Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India Glucose B.Braun 50 mg/mL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 year.
* Planed vaginal delivery
* Grand multiparity
* Twin pregnancy
* Polyhydramnios
* Previous history of PPH
* Macrosomic baby
* Prolonged labour
* HELLP syndrome
* Using of low-molecular weight heparin and Asprin during pregnancy.
* Vaginal birth after Cesarean section

Exclusion Criteria

* Intrauterine death.
* History of thromboembolic disease
* Current or previous history of heart disease ,renal and liver disorders
* History of seizure or epilepsy
* Placenta previa
* Placental abruptio
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shahla Alalaf

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shahla K. Alalaf, professor

Role: PRINCIPAL_INVESTIGATOR

Hawler Medical University

Sazgar A. Rashid, FIBOG

Role: STUDY_CHAIR

Ministery of Health

Chro S. Hassan, MBChB

Role: STUDY_CHAIR

Kurdistan Board for Medical Speciality

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kurdistan Board for Medical speciality

Erbil, Kurdistan Region, Iraq

Site Status

Maternity Teaching Hospital

Erbil, Kurdistan Region, Iraq

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iraq

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HawlerMU3

Identifier Type: -

Identifier Source: org_study_id