Duphaston (Dydrogesterone) for Recurrent Pregnancy Loss
Dydrogesterone 10 mg twice daily should be started immediately upon pregnancy confirmation and continued until 12 weeks of gestation in women with two or more consecutive spontaneous abortions, based on evidence showing a significant reduction in miscarriage rates from 29% to 13.4%. 1
Evidence-Based Dosing and Duration
The recommended dose is dydrogesterone 10 mg orally twice daily (20 mg total daily dose), initiated as soon as pregnancy is confirmed and continued through the 12th gestational week. 1
This regimen demonstrated statistically significant reduction in abortion rates compared to no treatment in women with a mean history of 3.5 prior spontaneous abortions (p ≤ 0.05). 1
Treatment should begin as early as possible after pregnancy confirmation to maximize benefit during the critical implantation and early placental development period. 1, 2
Mechanism and Safety Profile
Dydrogesterone is an oral retroprogesterone with high bioavailability and selective progesterone receptor activity, making it particularly suitable for early pregnancy support. 2, 3
The medication modulates maternal immune response by increasing T-helper 2 cytokines (IL-4, IL-6) while decreasing interferon-gamma, creating a favorable immunological environment for embryo acceptance. 4
No increased risk of pregnancy complications or congenital abnormalities has been observed with dydrogesterone use in early pregnancy. 1, 2
Critical Distinction from Preterm Birth Prevention
Important caveat: Dydrogesterone for recurrent miscarriage is NOT the same indication as progesterone for preterm birth prevention. The evidence provided shows:
For women with prior spontaneous preterm birth (not miscarriage), 17-alpha-hydroxyprogesterone caproate (17P) 250 mg intramuscularly weekly from 16-20 weeks until 36 weeks is the recommended therapy. 5, 6, 7
Vaginal progesterone is indicated for short cervical length (≤20 mm) detected at 18-24 weeks, not for recurrent first-trimester losses. 5, 6
Clinical Implementation
Begin dydrogesterone 10 mg twice daily immediately when pregnancy test is positive in women with ≥2 consecutive spontaneous abortions. 1
Continue treatment through gestational week 12, when the placenta assumes progesterone production. 1, 2
Standard prenatal care should be provided concurrently; dydrogesterone is an adjunct to, not a replacement for, comprehensive obstetric management. 1
The medication has demonstrated efficacy specifically in unexplained recurrent spontaneous abortion, with a well-established safety profile spanning decades of clinical use. 2, 3