Effect of combination of Oxytocin and Misoprostol and Oxytocin alone in third stage of labor of emergency caesarean delivery
Phase 3
- Conditions
- Health Condition 1: O720- Third-stage hemorrhage
- Registration Number
- CTRI/2024/03/064554
- Lead Sponsor
- Jawaharlal Institute of Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Pregnant women = 18 years of age
2. Gestational age =37 weeks to 42 weeks
3. Following singleton emergency lower segment caesarean
delivery
4. Under regional anaesthesia
Exclusion Criteria
1. Antepartum haemorrhage
2. Pre-existing bleeding disorders
3. Coagulation disorders
4. Fever (greater than 38degree C)
5. Acute Gastroenteritis
6. Known hypersensitivity to Oxytocin or Misoprostol
7. Distressed due to labour pains to give informed consent
8. Liver and Renal Impairment
9. Severe Anaemia
10. On Steroid therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if <br/ ><br>bleeding continues beyond one hour)Timepoint: Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if <br/ ><br>bleeding continues beyond one hour)
- Secondary Outcome Measures
Name Time Method 1. Need for additional uterotonics <br/ ><br>2. Uterine massage, bimanual uterine compression <br/ ><br>3. Duration of the third stage of labour (in minutes) <br/ ><br>4. Surgical intervention (Balloon tamponade or compression sutures or stepwise pelvic devascularization or peripartum hysterectomy) <br/ ><br>5. Blood transfusion <br/ ><br>6. Severe maternal morbidity like ICU admission, Shock (shock index greater than or equal to 0.9) <br/ ><br>7. Retained placenta requiring manual removal of placenta <br/ ><br>8. Change in haemoglobin level (Predelivery-24 hours postpartum) (g per dl) <br/ ><br>9. Hypotension <br/ ><br>10. Nausea and vomiting <br/ ><br>11. Fever (greater than or equal to 38 degree C) <br/ ><br>12. Shivering <br/ ><br>13. Abdominal pain <br/ ><br>14. Diarrhoea <br/ ><br>15. Maternal deathTimepoint: Till discharge from the hospital