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Addition of 400 microgram misoprotol to routine management of third stage of labour in women at risk for bleeding after delivery.

Efficacy and safety of 400 microgram misoprostol by sublingual route to augment routine management of third stage of labour in high risk women following vaginal delivery.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/03/004491
Enrollment
200
Registered
2014-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Pregant women with known High risk factors for post partum hemorrhage.

Interventions

Intervention1: Misoprostol 400 microgram: Sublingual 400 microgram misoprostol and 10 units oxytocin intramuscular within 1 minute of delivery of newborn( second baby in case of twin) Control Interven

Sponsors

NRS MEDICAL COLLEGE KOLKATA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with one or more of the high risk factors as multiple pregnancy • polyhydramnios • prolonged labour • labor augmented by oxytocin. • H/O PPH in previous pregnancy. • Post caesarean section (for vaginal delivery) • Obese patient (BMJ >30) • Grand multipara • APH • Severe preeclampsia/eclampsia. • Anaemia(hb

Exclusion criteria

Exclusion criteria: Any contraindications for the use of misoprostol and oxytocin such as known hypersensitivity, asthma, epilepsy etc. Cardiovascular, hepatic, haematological disorders. Temperature >38ï?°C

Design outcomes

Primary

MeasureTime frame
Blood loss after delivery and incidence of Post partum HaemorrhageTimepoint: From delivery of the newborn to 1 hour after delivery—

Secondary

MeasureTime frame
1.Post parum drop of Haemoglobin concentration 2. need for additional oxytocic and blood transfusion 3. complications and side effectsTimepoint: 1. 24 hours after delivery 2. 24 hours after delivery 3. 24 hours after delivery—

Countries

India

Contacts

Public ContactDrPICKLU CHAUDHURI

NRS MEDICAL COLLEGE,KOLKATA

picklu.chaudhuri@gmail.com9432277443

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 3, 2026