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Prescribing information and adverse event reporting can be found HERE
The UK’s first and only licensed progesterone treatment for preventing miscarriage in women with a history of recurrent miscarriage who present with bleeding in the first trimester. The recommended dose is 400 mg twice a day (morning and night).1
Treatment should be initiated during the first trimester of pregnancy, at first sign of vaginal bleeding and should continue to the 16th week of gestation.1
Understanding recurrent miscarriage
It takes a great deal of personal strength and resilience to continue trying for a baby after pregnancy loss — especially if it isn’t the first time it’s happened.
In a literature review of 9 studies from Europe and North America, compared to women with no previous history of miscarriage (11%), the risk of miscarriage increases by around 10% for each additional miscarriage, reaching 42% in women with three or more previous miscarriages.2
Beyond being prescribed treatment that may increase the chance of a successful pregnancy after recurrent miscarriages,4,5 these parents and their loved ones need support to help mitigate the impact of anxiety, and to promote a positive and hopeful mindset when trying again.
Support
It is estimated that there are around 250,000 miscarriages each year in the UK.3
What is Prometrium?
The UK’s first and only licensed progesterone treatment for preventing miscarriage in women with a history of recurrent miscarriage who present with bleeding in the first trimester.1
The recommended dose is 400 mg administered vaginally, twice a day (morning and night). Treatment should be initiated during the first trimester of pregnancy, at first sign of vaginal bleeding and should continue to the 16th week of gestation.1
Support
Why prescribe Prometrium?
The PRISM trial was a randomised, double-blind, placebo-controlled study that compared the use of vaginal progesterone (400mg, given twice a day) for early pregnancy bleeding with a placebo, administered until 16 weeks of gestation.
The primary endpoint — incidence of live births after at least 34 weeks of gestation — was not met. In a post-hoc sub-group analysis, vaginal progesterone capsules showed a 28% relative increase in live birth rate compared to placebo (with an absolute increase of 15%) in women with ≥3 previous miscarriages. Live birth rate was 72% (98/137) (progesterone) vs 57% (85/148) (placebo).4
In a post-hoc subgroup analysis:
Live birth rate (%) in women with ≥3 previous miscarriages4
% of patients
Safety Information
Local intolerance (burning, itching or oily discharge) has been observed. When used as recommended, transient fatigue or dizziness may occur within 1 to 3 hours of taking the medicine. Vaginal discharge and haemorrhage have been reported, the frequency of which is unknown.1 Please refer to the Summary of Product Characteristics for further information.
From providing the appropriate patient information leaflet, to offering online content designed specifically to reassure, Prometrium is the only licensed progesterone that can help you to give patients with early pregnancy bleeding and a previous history of recurrent miscarriage, the chance of a successful pregnancy, whilst providing the most support you can throughout.
View Summary of Product Characteristics
NICE, RCOG and ESHRE guidance support the use of progesterone in women presenting with bleeding in the first trimester of pregnancy with a history of recurrent miscarriages.6-8
28%
relative increase in live birth rate compared to placebo (with an absolute increase of 15%) in women with ≥3 previous miscarriages.4When is Prometrium prescribed?
Prometrium 400mg may be prescribed to women with a history of recurrent miscarriage, at the first sign of vaginal bleeding during the first trimester of pregnancy.¹
Treatment should always be individualised to the patient. A complete medical examination must be performed before starting the treatment and regularly during the treatment. The decision to treat women who have experienced recurrent miscarriages should follow further investigation and is at the discretion of the clinician.¹
The recommended dose is 400 mg twice a day (morning and night). Treatment should be initiated during the first trimester of pregnancy, at first sign of vaginal bleeding and should continue to the 16th week of gestation.¹
To support prescribing within your healthcare setting, you can download the Prometrium formulary pack below.
Please consider information about special warnings, precautions and contraindications.
Prometrium 400mg soft vaginal capsules contains soybean lecithin and may cause hypersensitivity reactions (urticarial and anaphylactic shock in hypersensitive patients). As there is a possible relationship between allergy to soya and allergy to peanut, patients with peanut allergy should avoid using Prometrium 400mg soft vaginal capsules.¹
Please consult the Summary of Product Characteristics for further information.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd, Drug Safety on 0203 862 0920 or email drugsafety@besins-healthcare.com
- Electronic Medicines Compendium (eMC) (2024). Prometrium 400mg soft vaginal capsules – Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/16016/smpc Accessed November 2025.
- Quenby S, et al. Lancet. 2021;397(10285):1658-67. doi:10.1016/S0140-6736(21)00682-6
- Austin L, et al. Camb Q Healthc Ethics. 2021;30(1):175-87. doi:10.1017/S0963180120000651. PMID: 33371918.
- Coomarasamy A, et al. N Engl J Med 2019;380:1815-24
- Devall AJ, et al. Cochrane Database of Systematic Reviews. 2021:4 doi:10.1002/146518.
- NICE 2021 Ectopic pregnancy and miscarriage: diagnosis and initial management (NG126) https://www.nice.org.uk/guidance/ng126; accessed November 2025.
- Regan L, Rai R, Saravelos S, Li T-C, on behalf of the Royal College of Obstetricians and Gynaecologists. Recurrent Miscarriage: Green-top Guideline No. 17. BJOG. 2023; 130(12): e9–e39. Accessed November 2025
- ESHRE guideline: recurrent pregnancy loss. Update 2022, can be accessed from https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Recurrent-pregnancy-loss.aspx Accessed November 2025