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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05840471
Other study ID # HMU5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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