Tranexamic Acid as an Intervention in Abruptio Placenta

Vaginal Bleeding Clinical Trial

Official title:

Tranexamic Acid in Pregnant Women With Abruptio Placenta: A Double-blind, Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840471
• Other study ID #: HMU5
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2024
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality

Description:

Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 10, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 24 weeks gestation and more
• Stable hemodynamically
• Accepted to participate

Exclusion Criteria:

• Hypersensitivity to tranexamic acid
• Defective color vision
• History of venous thromboembolism
• Pre-existing medical conditions that could affect pregnancy outcomes (diabetes mellitus, hypertension, renal disease)
• Smoker
• Refused to participate in the trial

Related Conditions & MeSH terms

• Abruptio Placentae
• Pregnancy, Prolonged
• Prolonged Pregnancy
• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

Drug:
• 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.

Other:
• Glucose water 5%
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.

Locations

Country	Name	City	State
Iraq	Shahla Kareem Alalaf	Erbil	Kurdistan Region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal blood loss	Vaginal bleeding soaked the underwear or requires a pad	Up to time of delivery
Primary	Gestational age	Ultrasound estimation of gestational age at each admission to hospital	Up to time of delivery
Primary	Favorable perinatal outcome	Delivery of newborn with APGAR scores of 7 and more, gestational age 36 weeks, and; more, birth weight of 2.5 kg and more	7 days post partum