Interventional Drug in Placenta Previa
Conditions
Keywords
Placenta previa, Tranexamic acid, intervention, Double blind
Brief summary
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women
Detailed description
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.
Interventions
DRUGTranexamic acid injection
Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours
OTHERGlucose water 5%
Placebo group 30ml will be received 12 hourly for 48 hours
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Two similar size syringes will be prepared and labeled as A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and syringe B (placebo group) containing 30 mL of 5% glucose water. The 2 groups of syringes will be labeled with different numbers not known by the investigator or the patient
Intervention model description
Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research . Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant at 28 weeks gestation and more * Vaginal bleeding due to placenta previa * Stable hemodynamically * Accept to participate in the trial
Exclusion criteria
* Hypersensitivity to tranexamic acid * Acquired defective color vision * History of venous thromboembolism * Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease) * Smokers * Refused to participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To stope or decrease vaginal bleeding | Up to time of delivery | Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa |
| Prolong pregnancy to 36 weeks | Up to delivery of the fetus | Decreased vaginal bleeding may prolong pregnancy |
| Favorable perinatal outcome | 7 days post partum | Delivery of active newborn at or more than 36 weeks gestation |
Countries
Iraq
Outcome results
None listed