To compare blood loss after normal delivery with use of oxytocin alone and oxytocin with misoprotol

Camparison of the efficacy of the combination of the Oxytocin and Rectal Misoprostol (600mcg) with Oxytocin alone for active manaegment of third stage labour following singleton vaginal delivery - A randomised, double binded, placebo-controlled trial (OxyPGE1 Trial) - OxyPGE1 Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059156

Enrollment

576

Registered

2023-10-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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 Misoprostol 600mcg per rectal: Study arm - AMTSL with Injection Oxytocin 10IU IM and Tablet Misoprostol 600mcg per rectal wi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women = 18 years of age 2. Gestational age =37 weeks to 42 weeks 3. Following singleton vaginal delivery

Exclusion criteria

Exclusion criteria: 1. Antepartum haemorrhage 2. Pre-existing bleeding disorders 3. Fever ( >38?C) 4. Acute Gastroenteritis 5. Known hypersensitivity to Oxytocin or Misoprostol 6. Distressed due to labour pains to give informed consent

Design outcomes

Primary

Measure	Time frame
Blood loss in mlTimepoint: 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 third stage of labour (in minutes) 4. Surgical intervention (Balloon tamponade/compression sutures/stepwise pelvic devascularization/peripartum hysterectomy) 5. Blood transfusion 6. Severe maternal morbidity: ICU admission, Shock (shock index =0.9) 7. Retained placenta requiring manual removal of placenta 8. Change in haemoglobin level (Predelivery-24 hours postpartum) (g/dl) 9. Nausea & vomiting 10. Fever (=38°C) 11. Shivering 12. Abdominal pain 13. Diarrhoea 14. Maternal deathTimepoint: After 24hours	—

Measure

Time frame

1. Need for additional uterotonics 2. Uterine massage, bimanual uterine compression 3. Duration of third stage of labour (in minutes) 4. Surgical intervention (Balloon tamponade/compression sutures/stepwise pelvic devascularization/peripartum hysterectomy) 5. Blood transfusion 6. Severe maternal morbidity: ICU admission, Shock (shock index =0.9) 7. Retained placenta requiring manual removal of placenta 8. Change in haemoglobin level (Predelivery-24 hours postpartum) (g/dl) 9. Nausea & vomiting 10. Fever (=38°C) 11. Shivering 12. Abdominal pain 13. Diarrhoea 14. Maternal deathTimepoint: After 24hours

—

Countries

India

Contacts

Public ContactT Parvathi

Jawarharlal Institute of Postgraduate Medical Education and Research

parvathinaik1@gmail.com9566537193

Outcome results

None listed

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