Tranexamic Acid as an Intervention in Placenta Previa

Hawler Medical University

Status: Completed

Conditions: Interventional Drug in Placenta Previa

Treatments: Other: Glucose water 5%; Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05688111

HawlerMU5

Details and patient eligibility

About

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women

Full 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.

Enrollment: 146 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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146 participants in 2 patient groups, including a placebo group

Tranexamic acid group

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic acid injection

Glucose water group

Placebo Comparator group

Description:

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.

Treatment:

Other: Glucose water 5%