Heat stable Carbetocin versus Oxytocin in Active Management of the third stage of Labour to Prevent Postpartum Haemorrhage in women delivering vaginally.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- THE PROPERTION OF WOMEN HAVING BLOOD LOSS MORE THAN 500 ML WITH IN 2 HOUR OF DELIVERY .
Study Overview
Brief Summary
The landmark WHO CHAMPION( CarbetocinHAeMorrhagePreventION) trial a double blinded randomized trial concluded Heat-stable carbetocin was not inferior to Oxytocin for the prevention of bloodloss of at least 500 ml or the use of additional uterotonic agents(9). In December 2018, WHO issued new recommendationson uterotonics for PPH prevention.Oxytocin 10 IU I/M or I/V remains the uterotonic of choice for all births, other uterotonics recommended are misoprostol, ergometrine/methylergometrine, and oxytocin plus ergometrine fixed-dose combination. Carbetocin 100ug I/V or I/M is recommended in context based manner .The use of carbetocin (100 μg, IM/IV) is recommended for the prevention of PPH for allbirths in contexts where its cost is comparable to other effective uterotonics(10).
However in India oxytocin and misoprostol remain the two most widely used uterotonicsto prevent PPH. The quality of these two may be poor dueto manufacturing or degradation during transport andstorage or exposure to climactic conditions ,oxytocine required cold storage . there by compromising their effectiveness in preventing PPH(11). Though misoprostol not required cold storage , The quality of misoprostol is also adversely impacted by high humidity inresource poor countries and poor packaging.
In 2020, a systematic review across 40 Low middle income countries(LMICs) furtherconfirmed that oxytocin and misoprostol are oftenof poor quality with nearly 40% of each failing qualitytests(12).
In Addition, ergometrine or the fixed dose combination of oxytocin and ergometrine require screening of hypertension before there use which may not be possible in some healthcare setting especially in the rural areas. As mentioned above the advantages of carbetocin it can cut on cost of the heat sensitive uterotonics in their acquisition, cold chain transport and storage, administration of additional uterotonics, requirement of blood transfusions etc.
There are very limited studies in our country which focuses on the comparative efficacy of carbetocin versus oxytocin or other uterotonics and the cost-effectiveness of the drug which has the potential of a good alternative first line drug in prevention of PPH especially in LMICs. Therefore, we aim to compare the effectiveness and side-effect profile of Hs- carbetocin versus oxytocin in prevention of PPH at third stage of labour following vaginal delivery.
There is a difference in the effectiveness of Heat stable Carbetocin as compared to Oxytocin in the prevention of postpartum haemorrhage in vaginal delivery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Age 18 TO 35 years Pregnant patients with gestational age more than or equal to 37 weeks Singleton pregnancy with cephalic presentation Expected to deliver vaginally with cervical dilatation more than or equal to 5 cm Hemoglobin more than 9gm in recent 3rd trimester report Willing to participate in the study.
Exclusion Criteria
- •Previous lower segment caesarean section High risk including antepartum haemorrhage traumatic Postpartum haemorrhage abruption placenta recurrent pregnancy loss multiple pregnancies polyhydramnios perineal or cervical tears during Labour and delivery Medical disorders such as coagulation disorder thrombocytopenia renal disorder hepatic disorder severe cardiac disorder asthma epilepsy Patients with previous uterine surgery Patients requiring blood transfusion before delivery Patient allergy to carbetocin Patients are not willing to sign informed consent.
Outcomes
Primary Outcomes
THE PROPERTION OF WOMEN HAVING BLOOD LOSS MORE THAN 500 ML WITH IN 2 HOUR OF DELIVERY .
Time Frame: THE PROPERTION OF WOMEN HAVING BLOOD LOSS MORE THAN 500 ML WITH IN 2 HOUR OF DELIVERY .
Secondary Outcomes
- the proportion of women requiring additional uterotonics in active managment of third stage of labour(the proportion of women requiring blood transfusion)
Investigators
Dr Suraj Ashokrao Mokade
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR