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To compare the effect of IM inj 10U oxytocin V/s Oral tablet Misoprostol in active management of third stage of labour

Comparative study of Oxytocin 10 IU IM V/s Oral Misoprostol 600 MCG in active management of third stage of labour - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070533
Enrollment
146
Registered
2024-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: O721- Other immediate postpartum hemorrhage

Interventions

Intervention1: Inj Oxytocin: 10 IU Intramuscularly after delivery of baby Control Intervention1: Tablet Misoprostol: 600 mcg orally after delivery of baby

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with gestational age more than 28 weeks and at low risk , undergoing vaginal delivery. 2. Patients having the ability and willingness to provide an informed consent.

Exclusion criteria

Exclusion criteria: 1. Hb under 8gm 2. Previous pregnancy associated with PPH. 3. Patient with traumatic PPH due to genital laceration. 4. Antepartum haemorrhage. 5. Multiple pregnancies. 6. Non-cephalic presentation. 7. Multipara, big baby, fibroid uterus, polyhydramnios 8. Previous LSCS 9. Hypertension, pre-eclampsia or pregnancy induced hypertension. 10. Intra uterine death. 11. Seizures, diabetes, renal anomalies, cardiac arrest or coagulation disorders. 12. Choriamnionitis 13. Polyhydraminos. 14. Epidural anaesthesia. 15. Bronchial asthma or respiratory disorders.

Design outcomes

Primary

MeasureTime frame
1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery and on day 2 post-delivery of two intervention groups. 2. To assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage Timepoint: 1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery-baseline and post-delivery at day 2 and on discharge of two intervention groups. 2. To assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage post delivery

Secondary

MeasureTime frame
1.To ascertain the side effects of the IM oxytocin & oral misoprostol 2. Need of blood transfusion Timepoint: To be decided at the time of discharge on day 2 after delivery of baby

Countries

India

Contacts

Public ContactDr Heena Vaswani

Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune

shilpa.kshirsagar@dpu.edu.in9689904101

Outcome results

None listed

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