Women with Higher Risk of Miscarriage to be Offered Progesterone: Updated Guidance

Dawn O'Shea

November 29, 2021

New recommendations on the management of women presenting with threatened miscarriage are included in updated guidance on the diagnosis and treatment of ectopic pregnancy and miscarriage, published by the National Institute for Health and Care Excellence (NICE).

It is now recommended that women with confirmed intrauterine pregnancy with a fetal heartbeat who present with early pregnancy vaginal bleeding with no history of previous miscarriage should be advised to return for further assessment if the bleeding gets worse or persists beyond 14 days. If the bleeding stops, she should start or continue routine antenatal care.

However, in women with a confirmed intrauterine pregnancy and a history of miscarriage who present with vaginal bleeding, vaginal micronised progesterone 400 mg twice daily should be prescribed. This will standardise the preparation of progesterone used to treat threatened miscarriage.

Following advice from the Society and College of Radiographers, after publication of the draft guidelines in August 2019, NICE added a recommendation to clarify that the presence of an intrauterine pregnancy should be confirmed on a scan. This will reduce the risk to women with a pregnancy of unknown location or an ectopic pregnancy being given progesterone. However, to avoid delay in starting treatment, the guidelines advise that progesterone can be initiated before a fetal heartbeat is detected.

If a fetal heartbeat is confirmed in a woman receiving progesterone, treatment should continue until 16 completed weeks of pregnancy.

Off-Label Use

At present, this is an off-label use of vaginal micronised progesterone and, as such, the prescriber is required to take full responsibility for the decision. This includes considering the contraindications, warnings, monitoring requirements, and other safety recommendations for the medicine.

As a scan is needed to confirm intrauterine pregnancy, it is advised that the initial prescription for progesterone should be provided at the Early Pregnancy Unit. Continued prescribing for the 16-week period can be provided by a GP.

The new recommendations for the use of progesterone are only for women with early pregnancy bleeding and a history of miscarriage. The recommendations do not apply to women who have already received mifepristone.

A recommendation has been made for additional research to assess the use of progesterone in women with recurrent miscarriage. The guidelines committee acknowledged that there is no evidence of harm to the mother or baby from the use of progesterone, although the evidence is insufficient to rule out the possibility of rare events.

National Institute for Health and Care Excellence. Ectopic pregnancy and miscarriage: diagnosis and initial management. NICE guideline [NG126]. Published: 17 April 2019. Updated: 24 November 2021. https://www.nice.org.uk/guidance/NG126


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