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Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

Phase 2
Conditions
Placenta Previa
Interventions
Drug: Tranexamic acid tablets
Drug: Placebo oral tablet
Registration Number
NCT04055194
Lead Sponsor
Ain Shams University
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
200
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Tranexamic acid groupTranexamic acid tablets100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Placebo groupPlacebo oral tablet100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
Primary Outcome Measures
NameTimeMethod
Amount of bleeding during antepartum bleeding attacks9 weeks GA

Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.

Secondary Outcome Measures
NameTimeMethod
Number of PRBCs units required during antepartum blood transfusion9 weeks GA

Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.

Number of women requiring antepartum blood transfusion9 weeks GA

Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.

Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery9 weeks GA

Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery

Gestational age at delivery9 weeks GA

Gestational age in weeks at the time of delivery

Neonatal intensive care unit (NICU) admission9 weeks

Number of neonates requiring NICU admission.

Trial Locations

Locations (1)

Ain SHams Maternity Hospital

🇪🇬

Cairo, Abbaseya, Egypt

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