Tranexamic Acid as an Intervention in Placenta Previa

Not Applicable

Completed

• Conditions: Interventional Drug in Placenta Previa
• Interventions: Other: Glucose water 5%; Drug: Tranexamic acid injection

• Registration Number: NCT05688111
• Lead Sponsor: Hawler Medical University

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.

Study Timeline

• Study Start: 2022-12-10
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-18
• Primary Completion: 2023-12-03
• Study Completion: 2023-12-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

• Pregnant at 28 weeks gestation and more
• Vaginal bleeding due to placenta previa
• Stable hemodynamically
• Accept to participate in the trial

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose water group	Glucose water 5%	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.
Tranexamic acid group	Tranexamic acid injection	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. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. 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.

Primary Outcome Measures

Name	Time	Method
Favorable perinatal outcome	7 days post partum	Delivery of active newborn at or more than 36 weeks gestation
Prolong pregnancy to 36 weeks	Up to delivery of the fetus	Decreased vaginal bleeding may prolong pregnancy
To stope or decrease vaginal bleeding	Up to time of delivery	Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa

Trial Locations

Locations (2)

Kurdistan Board for Medical speciality; 🇮🇶 Erbil, Kurdistan Region, Iraq

Ariana kh. Jawad; 🇮🇶 Erbil, Kurdistan Region, Iraq