Tranexamic Acid as an Intervention in Abruptio Placenta

Not Applicable

Completed

• Conditions: Vaginal Bleeding; Prolonged Pregnancy
• Interventions: Drug: Tranexamic acid injection; Other: Glucose water 5%

• Registration Number: NCT05840471
• Lead Sponsor: Hawler Medical University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2023-01-10
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-04-22
• Study First Posted: 2023-05-03
• Status Verified: 2024-02
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-10
• Last Update Submitted: 2024-02-11
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shahla Kareem Alalaf; 🇮🇶 Erbil, Kurdistan Region, Iraq