Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-08-01

Brief Summary

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200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).

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Detailed Description

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Conditions

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Placenta Previa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pregnant women with symptomatic placenta previa with previous bleeding attacks will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo till delivery. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.

Study Groups

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Tranexamic acid group

100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.

Group Type ACTIVE_COMPARATOR

Tranexamic acid tablets

Intervention Type DRUG

Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.

Placebo group

100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.

Interventions

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Tranexamic acid tablets

Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.

Intervention Type DRUG

Placebo oral tablet

Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.

Intervention Type DRUG

Other Intervention Names

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Kapron(R)

Eligibility Criteria

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Inclusion Criteria

* Gestational age 28 weeks of gestation.
* Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
* Haemodynamically stable pregnant women.
* Maternal age:20-40years old.
* Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.

Exclusion Criteria

* Multiple pregnancy.
* Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
* Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
* Women have hypersensitivity or any contraindication to use of tranexamic acid.
* Pregnant women with placenta previa with doppler showing morbidly adherent placenta.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No