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a clinical trial to study the effects of per rectal misoprostol 400 microgram plus 5 units oxytocin iv and 5 units oxytocin iv in third stage of labour.

Comparative study of combined per rectal misoprostol and intravenous oxytocin infusion versus intravenous oxytocin infusion in third stage of labour.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/006136
Enrollment
500
Registered
2011-01-11
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

None listed

Interventions

Intervention1: oxytocin plus misoprostol: 5 units oxytocin infusion with 4 ml ringer lactate solution plus 400 microgram misoprostol per rectal Control Intervention1: oxytocin plus placebo tablet: 5 u

Sponsors

Bankura Sammilani Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women who will have spontaneous normal delivery of a live, singleton neonate, and absence of any contraindications for misoprostol or oxytocin use.

Exclusion criteria

Exclusion criteria: women delivered by cesarean, or had a history of antepartum hemorrhage or bleeding tendency. The diagnosis of hypertensive disorder with pregnancy or the need for anticoagulants also will serve as exclusion criteria.

Design outcomes

Primary

MeasureTime frame
1.Determination of hemoglobin and hematocrit changes between antenatal and post natal level 2.Incidence of post partum haemorrhage and estimation of average blood loss in third stage of labour 3.The length of the third stage of labour 4.The percentage of women requiring manual removal of Placenta and further oxytocin and blood transfusion requirement. 5.The side effects of the drugs Timepoint: a.In first stage and twenty four hours after delivery of placenta, blood will be collected for measurement of hemoglobin and hematocrit. b.Number of patients will have 500 ml or more blood loss in third stage of labour, patients who will have hemodynamic changes due to blood loss less than 500 ml and require blood transfusion will also be counted. c. Amount of blood loss in the third stage of labour. d.Time duration between delivery of fetus and placenta. e.Number of patients will have retained placenta despite controlled cord traction and uterotonic agent, requiring manual removal of placenta (placenta accreta, percreta and increta will be excluded).—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactPrabhat Chandra Mondal

Professor and Head

subhendu_dasgupta@yahoo.com9434358869

Outcome results

None listed

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