Management of threatened miscarriage and recurrent miscarriage: guidance on use of progesterone
The Progesterone Pathway ensures that women who have had at least one previous miscarriage and present with early pregnancy bleeding are offered vaginal micronised progesterone, where it is clinically indicated, and provides guidance on asymptomatic women with four or more previous miscarriages.
The dose of progesterone
Only vaginal micronised progesterone should be offered. The dose recommended is 400 mg twice a day.
Prometrium is now licenced for use in the prevention of miscarriage in women presenting with bleeding in the first trimester of pregnancy and have a history of recurrent miscarriages. This guideline is therefore recommending the use of this vaginal micronised progesterone for this patient group.
There are other types of vaginal micronised progesterone that are not licenced that are available (e.g. Utrogestan/Cyclogest) with recommended doses and these could be considered as an alternative to Prometrium, particularly if Prometrium is not available. These other unlicenced preparations would be prescribed off-label. Off-label prescribing means the product licence does not cover the indication or age for which the medicine is being prescribed. It is commonly used in some areas of medicine, such as in paediatrics. The General Medical Council (GMC) has published guidance to support the prescribing of unlicensed medicines and medicines off-label. The guidance states that doctors should usually prescribe licensed medicines in accordance with the terms of their licence but they may prescribe medicines off-label where, on the basis of an assessment of the individual patient, they conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient. In doing so, doctors must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy and take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring and any follow up treatment. The guidance also advises that if a doctor intends to prescribe a medicine off-label they should explain this to the patient and give the reasons for doing so. Please see the General Medical Council’s ‘Good practice in prescribing and managing medicines and devices’ (Section titled: Prescribing unlicensed medicines) for further information.