DSIR recognized | FWA approved-FWA00012971

CHAMPION Study

12. June, 2017 Uncategorized

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction
Timeline: 2016-2017 (On Going)

Principal Investigator: Dr. Archana Patel, Dr. Vaishali Khedikar, Smita Puppalwar, Dr. Takshashila Taksande, Dr. Vaishali Shelekar, Poonam Dehenkar, Ashwini Pachare, Pushpa Iyangar, Madhurani Umate, Monali Chachere, Rupali Naik, Archana Sathawane.

Background Research Work: Postpartum haemorrhage (PPH) is defined as a blood loss of 500 mL or more within 24 hours of delivery, while severe PPH (sPPH) is defined as a blood loss of 1000 mL or more within the same time frame. PPH is the leading cause of maternal mortality in low-income countries and it contributes to nearly a quarter of maternal deaths globally. PPH is a significant contributor to severe maternal morbidity and long term disability, as well as to a number of other severe maternal conditions, generally associated with more substantial blood loss, including shock and organ dysfunction.
The majority of deaths due to PPH could be avoided through the use of prophylactic uterotonics during the third stage of labour and by timely and appropriate management. Oxytocin (Intramuscular/intravenous [IM/IV] 10 IU) is recommended as the uterotonic drug of choice.
Despite oxytocin being a well-known peptide hormone, there is limited information on its stability at tropical temperatures. The manufacturer recommends storage under refrigeration in most countries and there is general acknowledgement that cold storage would help to maintain quality of oxytocin especially in settings where it is difficult to obtain cold storage regularly.
Carbetocin appears to be a promising agent in the prevention of PPH. The clinical and pharmacological properties of carbetocin are similar to those of oxytocin.

Objective: The trial has two primary objectives:

  1. To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.
  2. To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour.