Tranexamic Acid in Pregnancies With Vaginal Bleeding

Vaginal Bleeding During Pregnancy Clinical Trial

Official title:

Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632824
• Other study ID #: HawlerMU 27.7
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: January 18, 2020

Study information

• Verified date: January 2020
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.

Description:

Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in 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. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 18, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• pregnant woman having vaginal bleeding

• Second and third trimester of unknown etiology

• No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding

• Primigraivid, multiparous and grand multiparous woman

• Accept to participate in the trial

Exclusion Criteria:

• Hypersensitivity to tranexamic acid

• Women with acquired defective color vision

• History of venous thromboembolism

• Refused to participate

Related Conditions & MeSH terms

• Hemorrhage
• Uterine Hemorrhage
• Vaginal Bleeding During Pregnancy

Intervention

Drug:
• Tranexamic Acid
One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days . follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .

Locations

Country	Name	City	State
Iraq	Hawler Medical University	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	Cessation of vaginal bleeding as self-reported by women	Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format	7 days
Primary	Gestational age	Newborn delivered before, at or after 20 weeks gestation in weeks	up to 7 days postpartum
Primary	Rate of perinatal deaths	total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life	7 dya after delivery
Primary	Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10>	Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed 0-3, moderately depressed 4-6 and excellent condition 7-10	Up to fifth minutes of life