Tranexamic Acid in Pregnancies With Vaginal Bleeding

H

Hawler Medical University

Status

Completed

Conditions

Vaginal Bleeding During Pregnancy

Treatments

Drug: Tranexamic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT03632824
HawlerMU 27.7

Details and patient eligibility

About

Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.

Full description

Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis, and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.

Enrollment

139 estimated patients

Sex

Female

Ages

18 to 42 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • pregnant woman having vaginal bleeding
  • Second and third trimester of unknown etiology
  • No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding
  • Primigraivid, multiparous and grand multiparous woman
  • Accept to participate in the trial

Exclusion criteria

  • Hypersensitivity to tranexamic acid
  • Women with acquired defective color vision
  • History of venous thromboembolism
  • Refused to participate

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

139 participants in 2 patient groups, including a placebo group

interventional arm
Experimental group
Description:
Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid
Treatment:
Drug: Tranexamic Acid
comparative group
Placebo Comparator group
Description:
expectant management, including admission to hospital, ultrasound examination at least twice a week, regular blood coagulation tests, fetal wellbeing , frequent ultrasound performing for placenta location ,betamethasone administration for whom delivery was suspected
Treatment:
Drug: Tranexamic Acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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