Threatened miscarriage
Bleeding and/or cramping in early pregnancy with preserved fetal heartbeat. In most patients, the cause is embryonic chromosomal abnormality, and progesterone does not prevent miscarriage in this setting.
ICD-10 O20.03 drugs
Drugs used for this condition
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
- CDydrogesteroneNot recommended · Progestogens — pregnadiene derivativesDydrogesterone is an oral progestogen approved for threatened and recurrent miscarriage in the EU, Asia, and Russia. The evidence is conflicting: meta-analyses and some professional recommendations suggest a possible reduction in miscarriage risk (especially with recurrent loss), whereas NICE recommends vaginal micronized progesterone (from the PRISM trial) rather than dydrogesterone for bleeding with a previous miscarriage, and the quality of dydrogesterone data is rated as limited. The decision is individualized with an obstetrician.
- FMifepristoneNot recommended · Antiprogestins, selective progesterone receptor modulatorsMifepristone is an antiprogestin and contraindicated when continuing pregnancy is desired. Off-protocol or impromptu use is unacceptable. In a patient with cramping or spotting in a wanted pregnancy, mifepristone is not indicated and is hazardous.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit