Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

Placenta Previa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055194
• Other study ID #: AntenatalTRX-PP
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2019
• Source: Ain Shams University
• Contact: Amal Ramadan, MBBCh
• Phone: +201098093525
• Email: dr.amalramadan11[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Previa

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of women requiring antepartum blood transfusion	Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.	9 weeks GA
Secondary	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
Secondary	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
Secondary	Gestational age at delivery	Gestational age in weeks at the time of delivery	9 weeks GA
Secondary	Neonatal intensive care unit (NICU) admission	Number of neonates requiring NICU admission.	9 weeks