Addition of 400 microgram misoprotol to routine management of third stage of labour in women at risk for bleeding after delivery.
Recruiting
- Conditions
- Pregant women with known High risk factors for post partum hemorrhage.
- Registration Number
- CTRI/2014/03/004491
- Lead Sponsor
- NRS MEDICAL COLLEGE KOLKATA
- Brief Summary
The present study is a randomized double bind placebo controlled trial evaluating the efficacy and safety of 400 microgram misoprostol in addition to routine mangement of third stage of labour with 10 units of intramuscular oxytocin in women with high risk factors for PPH following vaginal delivery.The primary outcome measures are the postpartum blood loss and incidence of PPH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 200
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<10gm%).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood loss after delivery and incidence of Post partum Haemorrhage From delivery of the newborn to 1 hour after delivery
- Secondary Outcome Measures
Name Time Method 1.Post parum drop of Haemoglobin concentration 2. need for additional oxytocic and blood transfusion
Trial Locations
- Locations (1)
G&O OPD,ROOM NO-64. Kolkata WEST BENGAL
🇮🇳Kolkata, WEST BENGAL, India
G&O OPD,ROOM NO-64. Kolkata WEST BENGAL🇮🇳Kolkata, WEST BENGAL, IndiaDr Arindam MajumdarPrincipal investigator9231509828arindamsutia@gmail.com