Effect of combination of Oxytocin and Misoprostol and Oxytocin alone in third stage of labor of emergency caesarean delivery

Comparison of the efficacy of a combination of Intramuscular Oxytocin (10 IU) and Sublingual Misoprostol(600mcg) with Intramuscular Oxytocin alone for Active Management of the Third Stage of Labour following Singleton Emergency Caesarean delivery - A Randomised, Double-blinded, Placebo-Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064554

Enrollment

270

Registered

2024-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O720- Third-stage hemorrhage

Interventions

Intervention1: Study arm - AMTSL with Injection Oxytocin 10IU IM and Tablet Misoprostol600mcg sublingual: Study arm - AMTSL with Injection Oxytocin 10IU IM and Tablet Misoprostol600mcg sublingual will

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if bleeding continues beyond one hour)Timepoint: Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if bleeding continues beyond one hour)	—

Secondary

Measure	Time frame
1. Need for additional uterotonics 2. Uterine massage, bimanual uterine compression 3. Duration of the third stage of labour (in minutes) 4. Surgical intervention (Balloon tamponade or compression sutures or stepwise pelvic devascularization or peripartum hysterectomy) 5. Blood transfusion 6. Severe maternal morbidity like ICU admission, Shock (shock index greater than or equal to 0.9) 7. Retained placenta requiring manual removal of placenta 8. Change in haemoglobin level (Predelivery-24 hours postpartum) (g per dl) 9. Hypotension 10. Nausea and vomiting 11. Fever (greater than or equal to 38 degree C) 12. Shivering 13. Abdominal pain 14. Diarrhoea 15. Maternal deathTimepoint: Till discharge from the hospital	—

Measure

Time frame

1. Need for additional uterotonics 2. Uterine massage, bimanual uterine compression 3. Duration of the third stage of labour (in minutes) 4. Surgical intervention (Balloon tamponade or compression sutures or stepwise pelvic devascularization or peripartum hysterectomy) 5. Blood transfusion 6. Severe maternal morbidity like ICU admission, Shock (shock index greater than or equal to 0.9) 7. Retained placenta requiring manual removal of placenta 8. Change in haemoglobin level (Predelivery-24 hours postpartum) (g per dl) 9. Hypotension 10. Nausea and vomiting 11. Fever (greater than or equal to 38 degree C) 12. Shivering 13. Abdominal pain 14. Diarrhoea 15. Maternal deathTimepoint: Till discharge from the hospital

—

Countries

India

Contacts

Public ContactT Parvathi

Jawaharlal Institute of Postgraduate Medical Education and Research

Parvathinaik1@gmail.com9566537193

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026