Blood Loss, Postoperative, Blood Loss, Surgical, Cesarean Section
Conditions
Keywords
Tranexamic acid, Misoprostol, Cesarean delivery, Postpartum Hemorrhage Prevention, Hemoglobin Reduction, Obstetric Hemorrhage, Perioperative Blood Loss
Brief summary
Brief Summary The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment. The main questions the study aims to answer are: 1. Does intravenous tranexamic acid reduce the drop in hemoglobin more than rectal misoprostol after cesarean section? 2. Does intravenous tranexamic acid reduce blood loss during and within 2 hours after cesarean section more than rectal misoprostol? Researchers will randomly assign 214 women scheduled for cesarean section to receive either intravenous tranexamic acid or rectal misoprostol before surgery. All cesarean sections will be performed according to the hospital's standard procedures by experienced obstetricians. Participants will: i. Be randomly assigned to receive either intravenous tranexamic acid or rectal misoprostol before surgery. ii. Have their hemoglobin level measured before the cesarean section and again 2 hours after surgery. iii. Have blood loss measured during the operation and for 2 hours after surgery. iv. Have the duration of the operation recorded as part of the study. The results will help determine which treatment is more effective in reducing blood loss and preserving hemoglobin levels during and after cesarean section.
Interventions
DRUGIntravenous Tranexamic Acid
1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section
1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section
Sponsors
Medicare Hospital (Pvt) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 37 to 42 weeks of gestation * Planned cesarean section
Exclusion criteria
* Women with pre-eclampsia * Chronic hypertension * Multiple pregnancies * Preterm or postdate pregnancy * Previous cesarean section * Gestational diabetes * Fetal macrosomia * History of bleeding / clotting disorder * On anti-coagulation heparin / warfarin therapy * Non-reassuring cardiotocograph or poor progress of labor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Hemoglobin | Baseline at enrollment and postoperative within 2 hours | Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL). |
Countries
Pakistan
Contacts
STUDY_CHAIRShahid I Rao, FCPS
Medicare Hospital (Pvt) Limited
Outcome results
None listed