An interventional study of Tranexamic acid injection and Glucose water 5% in Interventional Drug in Placenta Previa, sponsored by Hawler Medical University. Completed at 2 sites in Iraq. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women
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.
94 studies on the registry are indexed under Placenta Previa; 20 are open to participants now.
This study's enrollment of 146 is above the median of 105 across 54 interventional studies indexed under Placenta Previa.
Browse Placenta Previa studies →Hawler Medical University is the lead sponsor of 59 studies on the registry; 6 are open to participants now.
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This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants.
Drug: Tranexamic acid injection
Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care.
Other: Glucose water 5%
Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours
Also known as: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India
Placebo group 30ml will be received 12 hourly for 48 hours
Also known as: Glucose B.Braun
To stope or decrease vaginal bleeding
Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa
Time frame: Up to time of delivery
Prolong pregnancy to 36 weeks
Decreased vaginal bleeding may prolong pregnancy
Time frame: Up to delivery of the fetus
Favorable perinatal outcome
Delivery of active newborn at or more than 36 weeks gestation
Time frame: 7 days post partum
Ran from Dec 2022 to primary completion in Dec 2023, 11 months.
Of 26 interventional studies with no phase under Placenta Previa, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's 11 months is below that.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Hawler Medical University