Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial

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).

Study Overview

• Status: Unknown
• Conditions: Placenta Previa
• Intervention / Treatment: Drug: Tranexamic acid tablets; Drug: Placebo oral tablet

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Abbaseya
    • Cairo, Abbaseya, Egypt, 002
      • Recruiting
      • Ain Shams Maternity Hospital
      • Contact: Amal Ramadan, MBBCh; Phone Number: 201098093525; Email: dr.amalramadan11@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Tranexamic acid tablets; Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.; Other Names: Kapron(R)
Placebo Comparator: Placebo group; 100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.	Drug: Placebo oral tablet; Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of bleeding during antepartum bleeding attacks	Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.	9 weeks GA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women requiring antepartum blood transfusion	Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.	9 weeks GA
Number of PRBCs units required during antepartum blood transfusion	Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.	9 weeks GA
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery	Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery	9 weeks GA
Gestational age at delivery	Gestational age in weeks at the time of delivery	9 weeks GA
Neonatal intensive care unit (NICU) admission	Number of neonates requiring NICU admission.	9 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Amal Ramadan, MBBCh, A Ramadan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: August 10, 2019
• First Submitted That Met QC Criteria: August 10, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 10, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: AntenatalTRX-PP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No