• Reference Number: HEY1485/2025
• Departments: Gynaecology
• Last Updated: 31 January 2025

Introduction

This leaflet has been produced to give you general information about your treatment / procedure / condition (delete as appropriate). Most of your questions should be answered by this leaflet. It is not intended to replace the discussion between you and your doctor, but may act as a starting point for discussion. If after reading it you have any concerns or require further explanation, please discuss this with a member of the healthcare team caring for you.

What is it?

Progesterone is a hormone which is naturally produced in pregnancy and is essential for the maintenance of pregnancy particularly for early pregnancy support. Low levels of progesterone have been linked to impending miscarriage and the presence of associated early pregnancy bleeding. Recent research indicates that progesterone supplementation may reduce the risk of miscarriage in women with a history of previous miscarriage.

Progesterone is also used in other areas of gynaecology in different formats including hormone replacement therapy.

Why am I having this treatment?

Following a systematic review of the research studies, the National Institute of Health and Care Excellence (NICE) updated their Miscarriage guidance in 2021. This included new recommendations on the use of progesterone for women who have vaginal bleeding in early pregnancy and have had one or more previous miscarriage.

The recommendations are very specific:

• It is for women who have vaginal bleeding and have previously had at least one miscarriage.
• They need to have had a scan that shows that there is a pregnancy in the uterus (womb).
• If a fetal (baby’s) heartbeat is seen on scan, treatment is continued until 16 completed weeks of pregnancy.

What is the treatment?

The treatment is with micronised progesterone which is identical in structure to naturally produced progesterone. This is in the form of progesterone pessaries which are inserted into the vagina twice a day. This is the most effective route of administration as supported by research.

What are the benefits and risks to me?

Progesterone is recommended to lower the risk of miscarriage in women who experience bleeding in early pregnancy and those who have experienced at least one miscarriage; however, progesterone will not prevent every miscarriage. Sadly, miscarriages will still occur despite progesterone use.

The is no evidence of harm for women or babies following the use of vaginal micronised progesterone, with no increase in risk of stillbirth, congenital abnormalities or adverse drug reactions.

Common side effects (may affect up to 1 in 10 people):

• Abdominal distension (swelling in the abdomen), abdominal pain, constipation
• Sleepiness
• Tiredness
• Hot flush
• Breast pain

Please inform the doctor or nurse if you have a history of any of the following:

• Have or have had blood clots in the legs, lungs, eyes or elsewhere in the body,
• Currently have or have had severe liver problems
• Have epilepsy.

What I need to know before starting progesterone pessaries?

This is an off-label use of vaginal micronised progesterone. This means its use for women who experience bleeding in early pregnancy with previous miscarriage is not within the medicine’s marketing authorisation. However, it is recommended by NICE as there is clear and strong evidence of benefit.

If your pregnancy is very early and too small to be able to see a fetus (baby) and heartbeat, you can still commence progesterone and a further scan will be arranged to confirm this.

What happens afterwards?

If you have not already, please book your pregnancy with your community midwife.

You should commence the pessaries as directed and continue until you reach 16 completed weeks of pregnancy.

If you are worried about anything including bleeding or pain during this time, please contact your gynaecology ward or Early Pregnancy Unit on the telephone numbers below.

The Early Pregnancy Assessment Unit:

Monday to Friday, between 08:00 am to 17:30 om on tel: 01482 608767  and

Saturday, Sunday and Bank Holiday’s, between 08:00 am to 15:00 pm

OUT OF THE ABOVE HOURS CONTACT: Cedar Ward, tel: 01482 604387 or EPAU on  tel: 01482 608767  which gets diverted to ward 30 out of hours.

General Advice and Consent

Most of your questions should have been answered by this leaflet, but remember that this is only a starting point for discussion with the healthcare team.

Consent to treatment

Before any doctor, nurse or therapist examines or treats you, they must seek your consent or permission. In order to make a decision, you need to have information from health professionals about the treatment or investigation which is being offered to you. You should always ask them more questions if you do not understand or if you want more information.

The information you receive should be about your condition, the alternatives available to you, and whether it carries risks as well as the benefits. What is important is that your consent is genuine or valid. That means:

• you must be able to give your consent
• you must be given enough information to enable you to make a decision
• you must be acting under your own free will and not under the strong influence of another person

Information about you

We collect and use your information to provide you with care and treatment. As part of your care, information about you will be shared between members of a healthcare team, some of whom you may not meet. Your information may also be used to help train staff, to check the quality of our care, to manage and plan the health service, and to help with research. Wherever possible we use anonymous data.

We may pass on relevant information to other health organisations that provide you with care. All information is treated as strictly confidential and is not given to anyone who does not need it. If you have any concerns please ask your doctor, or the person caring for you.

Under the General Data Protection Regulation and the Data Protection Act 2018 we are responsible for maintaining the confidentiality of any information we hold about you. For further information visit the following page: Confidential Information about You.

If you or your carer needs information about your health and wellbeing and about your care and treatment in a different format, such as large print, braille or audio, due to disability, impairment or sensory loss, please advise a member of staff and this can be arranged.