Tranexamic Acid in Pregnancies With Vaginal Bleeding

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2020-01-18

Brief Summary

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

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Detailed Description

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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.

Conditions

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Vaginal Bleeding During Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interventional arm

Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days .

follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .

comparative group

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

Group Type PLACEBO_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days .

follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .

Interventions

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Tranexamic Acid

One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days .

follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .

Intervention Type DRUG

Other Intervention Names

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Trenaxa , Manufacturer Macleods Pharmaceuticals TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens

Eligibility Criteria

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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