Heat-stable carbetocin for the prevention of postpartum haemorrhage*

Heat-stable carbetocin (HSC) training outline

Purpose:
Provide a technical update on heat-stable carbetocin (HSC) for the prevention of PPH* and train health care personnel in its use.

MODULE 1 PPH burden and clinical value of heat-stable carbetocin

Objectives

Understand:

  • Use of uterotonics for the prevention of PPH, including recent WHO recommendations
  • Importance of quality uterotonics for the prevention of PPH
  • Mode of action and other characteristics of HSC

MODULE 2 Training in the administration of heat-stable carbetocin

Objectives

Know:

  • Indication
  • Contraindications
  • Dosage and method of administration
  • Handling and storage
  • Reporting of adverse drug reactions

*Heat-stable carbetocin is indicated for the prevention of uterine haemorrhage due to postpartum uterine atony.

Causes of maternal death

PPH is the leading direct cause of maternal deaths worldwide3
Over 90% of deaths from PPH occur in low- and lower-middle income countries (LMICs)4

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Maternal morbidity

Maternal morbidity due to PPH has a negative impact on women, their families, and communities in LMICs

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  • Immediate health complications due to PPH include hypovolaemic shock, heart or renal failure, loss of fertility (hysterectomy), and sepsis5
  • Long-term consequences: when a mother experiences severe morbidities, it results in negative physical, psychological, financial, and social consequences, which can also have a negative impact on her family6-9

Infant* mortality

Maternal mortality and morbidity put children at great risk of death

  • Maternal mortality is associated with high infant mortality10-13
  • Evidence has found that a mother’s loss can devastate the livelihoods, quality of life, and survival chances of those she leaves behind14-17
  • Children who experienced an early maternal death are at 15 times the risk of dying18
  • Infants of women that experience obstetric complications face increased risk of death19-22

*Infant = child under 1 year old.

Economic risk

Failure to prevent PPH poses a significant economic burden to families and healthcare systems

  • Families who experience a maternal death or a near-miss event during labour and postpartum period spend substantially more on healthcare than those of an uncomplicated birth23-25
  • Failure to prevent PPH poses considerable costs to health systems, largely driven by the cost of blood transfusions, surgery, and extended stays in healthcare facilities or hospitals26-30

Heat-Stable Carbetocin is Different from Oxytocin

  • Carbetocin is a long acting synthetic analogue of oxytocin that contracts the uterus1
  • The 2018 WHO Recommendations1 support the use of carbetocin in the prevention of PPH for all births in contexts where its cost is comparable to other effective uterotonics. Carbetocin is recommended in settings where oxytocin is unavailable or its quality cannot be guaranteed
  • Carbetocin has been added to the WHO Model List of Essential Medicines2
  • Heat-stable carbetocin is approved for the prevention of uterine haemorrhage due to postpartum uterine atony following caesarean section & vaginal delivery (under the new Swissmedic and MAGHP* procedure)3

*MAGHP: Swiss Marketing Authorization for Global health Products.

Heat-Stable Carbetocin Indication

Heat-stable carbetocin is approved for the prevention of uterine haemorrhage due to postpartum uterine atony1*

Heat-stable carbetocin must be administered only after the delivery of the infant1,2

 

*Heat-stable carbetocin is not approved for use in all jurisdictions. Registration to some LMICs still ongoing.

Heat-stable carbetocin contraindications1

Heat-stable carbetocin must NOT be used:

  • For labour induction or labour augmentation
  • During pregnancy and labour before the childbirth
  • In women with serious cardiovascular disorders
  • In women with hepatic or renal disorders
  • In women with epilepsy
  • In women with hypersensitivity to carbetocin, oxytocin or any of the excipients according to the composition

HSC – Administration1

Heat-stable carbetocin must be injected as soon as possible after the birth of the infant and preferably before delivery of the placenta

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    HSC should only be administered by skilled health personnel.
Make sure this is not a multiple gestation. If another baby is present, do not inject HSC. Inject HSC after all of the babies are born.
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    The solution in the ampoule is for use undiluted for intravenous IV and intramuscular IM injection
    Use a 2ml syringe for injection
The ampoule solution should ​NOT be diluted before injection​
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    One ampoule of 1 mL (100 micrograms) is the dose for one patient
    Administering more than one dose is not recommended as it has not been studied

*Heat-stable carbetocin is indicated for the prevention of uterine haemorrhage due to postpartum uterine atony.

For IV injection

Heat-stable carbetocin can be administered in both vaginal birth and caesarean section.

1 ml (100 micrograms) administered slowly over 1 minute directly in the IV port.

Do not inject HSC into the intravascular fluid bag

IV: intravascular.

For IM injection

1 mL (100 micrograms) can also be administered intramuscularly.

IM: intramuscular.

Heat-stable carbetocin warnings1

  • The use of heat-stable carbetocin at any stage before delivery of the infant is not appropriate because its uterotonic activity persists for several hours
  • Rule out the presence of another baby (multiple gestation) before administration
  • Heat-stable carbetocin is contraindicated during pregnancy, including for the induction of labour
Never inject heat-stable carbetocin before the birth of the infant!

Heat-stable carbetocin interactions

  • Heat-stable carbetocin can be administered for prevention of PPH* even if oxytocin or other uterotonics have been given during labour
  • If bleeding occurs after administration of heat-stable carbetocin for the prevention of PPH*, follow local protocols
  • Tranexamic acid and/or uterotonics can be administered according to local standards

No interaction studies have been undertaken with carbetocin. During clinical trials, Carbetocin Ferring has been administered in association with analgesics, antibiotics, antiretrovirals, spasmolytics and agents used for epidural or spinal anaesthesia. No drug interactions were observed.

*Heat-stable carbetocin is indicated for the prevention of uterine haemorrhage due to postpartum uterine atony.

Click here to learn more.

Click here to learn more.

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32. World Health Organization Model List of Essential Medicines, 21st List, 2019. Geneva: World Health Organization; 2019.
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