Vaginal Bleeding During Pregnancy
Conditions
Keywords
Antepartum bleeding, Perinatal morbidity, Perinatal mortality, Preterm labor
Brief summary
Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.
Detailed 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.
Interventions
DRUGTranexamic 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 .
Sponsors
Hawler Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cessation of vaginal bleeding as self-reported by women | 7 days | Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format |
| Gestational age | up to 7 days postpartum | Newborn delivered before, at or after 20 weeks gestation in weeks |
| Rate of perinatal deaths | 7 dya after delivery | total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life |
| 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> | Up to fifth minutes of life | 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 |
Countries
Iraq
Outcome results
None listed