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Leaflet Details

Title Progesterone Treatment for the Management of Bleeding During Early Pregnancy
Department Early Pregnancy Unit
Author(s) Kay Shevill (Clinical Nurse Specialist Nurse Sonographer)
Review Date June 2026
Next Review June 2027
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Patient Information

The use of progesterone treatment for the management of bleeding during early pregnancy

The National Institute for Health & Care Excellence (NICE) offered guidance in 2021 for progesterone treatment for the management of bleeding during early pregnancy following the results of a large research study called ‘PRISM’ that was carried out across 48 Hospitals in the UK in 2019.

 

What is progesterone?

Progesterone is natural, essential hormone produced by the site of ovulation (i.e. where the egg was released) in the ovary. Progesterone is needed to support the lining of the uterus / womb in early pregnancy until the placenta is established and takes over this function.

 

The recommendations on the use of progesterone treatment are very specific:

It is for pregnant women with vaginal bleeding

It is for pregnant women who have previously had at least one miscarriage

An ultrasound scan shows there is a pregnancy in the uterus / womb

It is not for pregnant women who do not have vaginal bleeding

It is not for pregnant women who have not previously had at least one miscarriage

An ultrasound scan shows there is a pregnancy outside of the uterus / womb (i.e. ectopic pregnancy) or the ultrasound scan is inconclusive & the pregnancy is not seen (i.e. pregnancy of unknown location)

 

What is progesterone treatment?

The treatment, based on the research study, is with 400mg of micronised progesterone twice a day; usually morning & evening.

The commonly prescribed progesterone treatments are either Prometrium® or Cyclogest® or Utrogestan®. These are either a soft capsule (single) or pessaries (depending on the brand) that you insert deep into your vagina; like inserting a tampon. It is important that you familiarise yourself & then follow the specific instructions about using your medication (brand) on the prescription from your doctor and in the patient information leaflet contained inside the medication box. This progesterone treatment is continued until 16 weeks of pregnancy, unless you are instructed otherwise by your Obstetric team. There is no evidence to suggest that you need to gradually withdraw before stopping the progesterone treatment at 16 weeks of pregnancy.

 

Is it safe?

The current guidance states that progesterone treatment is considered safe & there are no known risks of harm to you or your baby. This is supported by a previous research study called Promise in 2015 that investigated progesterone treatment in unexplained miscarriage. However, we still lack the long-term data on the safety of progesterone & the existence of rare side effects cannot be entirely ruled out at this stage.

Please note that Prometrium® contains soybean lecithin (SOYA) and therefore those with a soybean lecithin (SOYA) allergy should avoid using Prometrium®. Also, as there is a possible relationship between allergy to soya and allergy to peanut, those with a peanut allergy should also avoid using Prometrium®.

Please ensure The Early Pregnancy Unit is aware if you have an allergy or hypersensitivity to peanuts or soybean lecithin (SOYA). If this is the case, another brand of progesterone treatment would be prescribed for you.

 

Does it work?

The research study data showed that if you have had one or two previous miscarriages, experience vaginal bleeding & an ultrasound scan shows there is a pregnancy in the uterus/womb, then progesterone treatment MAY increase your chances of having a successful pregnancy by around five percent. If you have had three or more miscarriages, then progesterone treatment may increase your chances of having a successful pregnancy by around fifteen percent. This was considered statistically significant.

The research study data did not show any benefits in progesterone treatment in those who have had no previous miscarriages.

 

Are there any side effects?

The published side effects of progesterone treatment include breast pain, drowsiness and gastrointestinal discomfort. However, for some, these can also be a part of normal early pregnancy symptoms. Many of those using progesterone treatment report a leakage of an oily or a white (non-smelly, non-itchy) vaginal discharge from the medication. Therefore, you may wish to use panty liners to protect your underwear. The soft capsule (single) or pessaries are usually administered vaginally but occasionally your clinician may subsequently advise another route of administration with some brands of progesterone treatment.

Occasionally the progesterone treatment can cause a slight burning, itching or irritation of the delicate vaginal tissues. If you have any questions about any side effects of progesterone treatment, then please call The Early Pregnancy Unit on 01932 722662 (Monday to Friday 0900-1700).

 

Do I have to use it?

It is important that you make an informed choice about whether or not you wish to start progesterone treatment. Regardless of your decision, your on-going care in The Early Pregnancy Unit will not be affected. If you have any questions about the use of progesterone treatment, then please call The Early Pregnancy Unit on 01932 722662 (Monday to Friday 0900-1700). It is important to remember that any prescription for progesterone treatment is only for use in your current pregnancy and should not be used in any future pregnancy; unless prescribed by a doctor.

 

What should I do if I have a problem, concern or question?

If you have any problems, concerns or questions about the use of progesterone treatment or if you are experiencing any side effects of progesterone treatment then please call The Early Pregnancy Unit on 01932 722662 (Monday to Friday 0900-1700).

Please note that the information contained within this leaflet is not relevant to those that have been prescribed progesterone treatment as part of a fertility treatment regime etc. In this instance, please contact the provider of your fertility treatment regime if you have any problems, concerns or questions about the use of progesterone treatment.

 

Sources for further help & advice:

NICE guidance
https://www.nice.org.uk/guidance/ng126

Tommy’s
https://www.tommys.org/pregnancy-information/health-professionals/early-pregnancy-bleeding-and-progesterone

PRISM study
‘A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy’ in The New England Journal of Medicine (2019)
(DOI: 10.1056/NEJMoa1813730)

Miscarriage UK website
https://www.miscarriageuk.org/

Royal College of Obstetrics and Gynaecology
https://www.rcog.org.uk/

 

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