Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Tranexamic Acid | Experimental | Participants will receive intravenous tranexamic acid |
|
| Rectal Misoprostol | Active Comparator | Participants will receive rectal Misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Tranexamic Acid | Drug | 1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Hemoglobin | Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL). | Baseline at enrollment and postoperative within 2 hours |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss | Total blood loss will be measured as the sum of blood collected in the suction container during surgery and blood absorbed by pre-weighed surgical gauze and sanitary pads (1 g = 1 mL) from the start of surgery until 2 hours after cesarean section. | From the start of cesarean section to postoperatively until two hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shahid I Rao, FCPS | Medicare Hospital (Pvt) Limited | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicare Hospital (Pvt) Limited | Multan | Punjab Province | 60000 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| rectal misoprostol | Drug | 1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section |
|
| D011183 | Postoperative Complications |