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

Sponsors

Lead Sponsor: Ain Shams University

Source 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).

Overall Status Recruiting
Start Date August 1, 2019
Completion Date August 1, 2020
Primary Completion Date July 1, 2020
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Amount of bleeding during antepartum bleeding attacks 9 weeks GA
Secondary Outcome
Measure Time Frame
Number of women requiring antepartum blood transfusion 9 weeks GA
Number of PRBCs units required during antepartum blood transfusion 9 weeks GA
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery 9 weeks GA
Gestational age at delivery 9 weeks GA
Neonatal intensive care unit (NICU) admission 9 weeks
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tranexamic acid tablets

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

Arm Group Label: Tranexamic acid group

Other Name: Kapron(R)

Intervention Type: Drug

Intervention Name: Placebo oral tablet

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

Arm Group Label: Placebo group

Eligibility

Criteria:

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.

Gender: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Amal Ramadan, MBBCh Principal Investigator A Ramadan
Overall Contact

Last Name: Amal Ramadan, MBBCh

Phone: +201098093525

Email: [email protected]

Location
Facility: Status: Contact: Ain SHams Maternity Hospital Amal Ramadan, MBBCh 201098093525 [email protected]
Location Countries

Egypt

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ain Shams University

Investigator Full Name: Amal Ramadan

Investigator Title: Clinical fellow of Obstetrics & Gynecology

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tranexamic acid group

Type: Active Comparator

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

Label: Placebo group

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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 Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

Source: ClinicalTrials.gov