Placenta Previa
Conditions
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).
Interventions
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
DRUGPlacebo oral tablet
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.
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).
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of bleeding during antepartum bleeding attacks | 9 weeks GA | Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of women requiring antepartum blood transfusion | 9 weeks GA | Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage. |
| Number of PRBCs units required during antepartum blood transfusion | 9 weeks GA | Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage. |
| Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery | 9 weeks GA | Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery |
| Gestational age at delivery | 9 weeks GA | Gestational age in weeks at the time of delivery |
| Neonatal intensive care unit (NICU) admission | 9 weeks | Number of neonates requiring NICU admission. |
Countries
Egypt
Contacts
Primary ContactAmal Ramadan, MBBCh
Outcome results
None listed