Prophylactic Tranexamic Acid Use After Vaginal Delivery

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Status: Completed

Conditions: Prophylactic Tranexamic Acid Use; Postpartum Hemorrhage; Vaginal Delivery

Treatments: Drug: Tranexamic acid; Other: 5% Dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT05429580

2011-KAEK-25 2021/07-22

Details and patient eligibility

About

In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.

Full description

It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.

Enrollment: 480 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton pregnant women
• woman between the ages of 18-45 years
• woman who gave birth at 34 weeks and above

Exclusion criteria

• Pregnancies with less than 1 hour period between hospitalization and delivery
• Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae
• Women with previous uterine surgery or cesarean section
• Women with a history of thromboembolism
• women with serious illness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

postpartum bleeding risks as low-risk

Other group

Description:

The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.

Treatment:

Other: 5% Dextrose

Drug: Tranexamic acid

postpartum bleeding risks as high-risk

Other group

Description:

The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.

Treatment:

Other: 5% Dextrose

Drug: Tranexamic acid