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Completed

NCT Number: NCT05688111

Tranexamic Acid as an Intervention in Placenta Previa

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women

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Key information

Conditions

Interventional Drug in Placenta Previa Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Placenta Previa Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ariana kh. Jawad, Erbil, Kurdistan Region, Iraq

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About this study

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant at 28 weeks gestation and more
  • Vaginal bleeding due to placenta previa
  • Stable hemodynamically
  • Accept to participate in the trial

Exclusion criteria

  • Hypersensitivity to tranexamic acid
  • Acquired defective color vision
  • History of venous thromboembolism
  • Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease)
  • Smokers
  • Refused to participate in the trial

Treatment and study plan

Tranexamic acid injection

Drug

Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours

Other names: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India

Glucose water 5%

Other

Placebo group 30ml will be received 12 hourly for 48 hours

Other names: Glucose B.Braun

Primary outcomes

  1. To stope or decrease vaginal bleeding

    Time frame: Up to time of delivery

    Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa

  2. Prolong pregnancy to 36 weeks

    Time frame: Up to delivery of the fetus

    Decreased vaginal bleeding may prolong pregnancy

  3. Favorable perinatal outcome

    Time frame: 7 days post partum

    Delivery of active newborn at or more than 36 weeks gestation

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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