- Women with bleeding in early pregnancy and a past history of miscarriage should be offered progesterone therapy from confirmation scan until 12 weeks gestation (or until 16 weeks gestation after counselling – see patient information leaflet in Appendix 1)
- An intrauterine pregnancy should be confirmed by scan before commencement of progesterone and this should confirm presence of an intrauterine sac +/- yolk sac
- In women who have had progesterone given in previously successful pregnancies and request this treatment again, advice should be given that there is no proven benefit (unless there is current bleeding) but also no proven harm. Prescription can be made on an individual basis.
- In women with a history of recurrent miscarriage (3 or more) who request treatment, advice should be given that there is no proven benefit (unless there is current bleeding) but also no proven harm. Prescription can be made on an individual basis.
Progesterone use in early pregnancy (1097)
Warning
Objectives
To provide guidance for the provision of progesterone therapy to women in early pregnancy
Audience
Healthcare Workers in primary and secondary care involved in the care of women in early pregnancy within GG&C
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This guideline is based on the recently updated NICE guidance (1), whose recommendations are taken from a review of 7 randomised controlled trials including the PRISM and Promise trials. It relates to the use of progesterone in women at risk of miscarriage.
Summary:
- No benefit of progesterone treatment was found for women with a threatened miscarriage who have no history of miscarriage.
- Benefit of using vaginal progesterone was found in women who had a threatened miscarriage and a history of one or more miscarriages.
- No benefit of progesterone treatment was found in women who had a history of recurrent miscarriage.
- No harm or adverse effects were found in women treated with progesterone
- The progesterone used should be a vaginal micronized preparation as below.
- 1st line : Cyclogest 400mg, administered vaginally twice a day.
- 2nd line Utrogestan 400mg, administered vaginally twice a day.
- Treatment should be commenced before 9 weeks as no proven benefit beyond this gestation. Can be discussed on an individualised basis if patient requests (see Patient information leaflet, Appendix 1)
- An initial prescription should be given at the Early Pregnancy Assessment Service (EPAS) after scan as above. The initial prescription will be for 2 weeks, which should then be continued by their GP until 12 weeks gestation (unless previous agreement to continue until 16 weeks)
- 2 copies of the Patient information leaflet and consent form should be signed, with 1 copy filed in patient notes and 1 copy given to the patient (Appendix 1)
- Hypersensitivity to progesterone, Sunflower oil, Soybean lecithin, Gelatin, Glycerol, Titanium dioxide (those allergic to peanuts may also be allergic to soya). Severe hepatic dysfunction, Undiagnosed vaginal bleeding, Mammary or genital tract carcinoma, Thrombophlebitis, Thromboembolic disorders, Cerebral haemorrhage, Porphyria.
- If a miscarriage occurs in women taking progesterone therapy, this should be stopped for 4 days prior to active medical management.