Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

NCT04055194 | Unknown Phase 2 DMC

• 1 other identifier: AntenatalTRX-PP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Tranexamic acid group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

Tranexamic acid tablets DRUG

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

Also known as: Kapron(R)

Tranexamic acid group

Placebo oral tablet DRUG

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

Placebo group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Amal Ramadan, MBBCh

  A Ramadan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Ramadan, MBBCh

CONTACT

+201098093525; dr.amalramadan11@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical fellow of Obstetrics & Gynecology

Model Details: 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).

Study Record Dates

• First Submitted: August 10, 2019
• First Posted: August 13, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)