1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [PALLAVIYDV97@GMAIL.COM].
   


6. For how long will this data be available start date provided 01-05-2023 and end date provided 01-12-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Approximately one-fourth of all maternal deaths are caused by postpartum haemorrhage (PPH), which has a prevalence of 6% worldwide and is a significant contributor to maternal mortality and morbidity. “PPH typically manifests within 24 hours of delivery, however it can also appear up to 12 weeks after the delivery”. PPH has reportedly became more prevalent and severe in a number of industrialised nations . Up to 80% of PPH cases are caused by uterine atony , which is also the most common cause of PPH. As a result, it is crucial to timely and effectively induce the uterine contractions soon after the childbirth.

It is seen that when active management of third stage of labour is done, probability of severe primary PPH, need for transfusion, and subsequent uterotonic therapy are all decreased . The most used and efficient uterotonic drug for preventing PPH is oxytocin . However, because to its early onset and short duration of action, it is best administered to initiate persistent uterotonic activity.

Oxytocin often requires several doses or other uterotonics to arrest haemorrhage which adds to various side effects and increase in expenditure of treatment.

In contrast to oxytocin, carbetocin (octapeptide) is a long-acting synthetic analogue of oxytocin (nonapeptide) which requires only single dose administration.  .Even after a single bolus injection of carbetocin, the uterotonic effects lasts for several hours.

Currently oxytocin is most frequently used as agent of first choice after vaginal delivery. Due to its short half-life (4 to 10 minutes), it requires continuous or frequently repeated administration. More recently carbetocin has been developed as a long acting oxytocin agonist and when administered it results in a sustained uterine contraction.

There is currently less data to evaluate the efficacy of carbetocin in women undergoing vaginal delivery for prevention of post-Partum haemorhage, hence we aim to do this study.

Ø  Study Type : Comparative Observational Study

Ø  Estimated sample size:    200

Ø  Allocation:  Randomized

Ø  Masking:  Single (Investigator)

Ø  Primary Purpose:  Treatment

Place of study: Department of Obstetrics and Gynecology JNMC, AVBRH, DMIHER (Deemed University), Wardha.

Duration of Study: 2023-2025

Study design:  Comparative Observational Study

Sample size: 200