Vaginal Bleeding, Prolonged Pregnancy
Conditions
Keywords
Abruptio placenta, Interventional study, Perinatal mortality, vaginal bleeding
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.
Interventions
DRUGTranexamic 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 Dextrose 5% in water intravenously twice daily in the acute stage of bleeding for 48 hours. 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.
OTHERDextrose 5% in water
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water intravenously twice daily in the acute stage of bleeding for 48 hours. 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.
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Two similar size syringes will be prepared and labeled as A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and syringe B (placebo group) containing 30 mL of 5% glucose water. The 2 groups of syringes will be labeled with different numbers not known by the investigator or the patient
Intervention model description
Randomization for both groups will be done using the Randomization Allocation Software program. Blindness in each group will be confirmed by a pharmacist who is not involved in the study and will have the codes belonging to the type of intervention with him until the end of the research. Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable perinatal outcome | up to 7 days post partum | viable newborn, birth weight of at least 2,500 grams, an Apgar score of at least 7, and no neonatal intensive care unit hospitalization. more, birth weight of 2.5 kg and more |
| Hemostasis | Up to time of delivery | complete or gradual cessation of vaginal bleeding |
| Gestational age | at time of delivery | 37 weeks and more |
Countries
Iraq
Outcome results
None listed