How to use Duphaston (dydrogesterone) in a pregnant woman with a threatened miscarriage?

Duphaston (Dydrogesterone) for Threatened Miscarriage

For women presenting with threatened miscarriage in the first trimester, administer dydrogesterone 40 mg orally as a loading dose, followed by 10 mg three times daily (or 10 mg twice daily) until one week after bleeding stops or until 12-14 weeks of gestation, whichever is longer. 1, 2, 3

Dosing Regimen

Loading and Maintenance Dose:

• Initial dose: 40 mg orally as a single stat dose 2, 4
• Maintenance: 10 mg three times daily (30 mg total daily) 1, 4 OR 10 mg twice daily (20 mg total daily) 2, 3
• Duration: Continue until 1 week after vaginal bleeding stops 2, 3 OR until 12-14 weeks of gestation if bleeding persists 4, 5
• Maximum duration: Up to 14 weeks of gestation unless miscarriage is confirmed earlier 4

Clinical Evidence Supporting Use

Efficacy Data:

• Dydrogesterone reduces miscarriage rates by approximately 47% compared to standard care (13% vs 24% miscarriage rate, absolute risk reduction of 11%) 1
• Success rates (pregnancy continuing beyond 20 weeks) are significantly higher with dydrogesterone: 87.5% vs 71.6% with conservative management alone 2
• Miscarriage rates are reduced from 25-28% in untreated groups to 12.5-17.5% with dydrogesterone treatment 2, 3

Patient Selection Criteria

Appropriate candidates include:

• Women aged 20-39 years presenting with vaginal bleeding with or without abdominal cramps during 5-16 weeks of gestation 4, 2
• First-trimester threatened miscarriage with viable pregnancy on ultrasound 1
• Exclude: Women with history of recurrent miscarriage (≥3 prior losses), as this population requires different evaluation and management 2

Safety Profile

Maternal and Fetal Safety:

• Adverse effects are minimal across multiple studies 1
• No increased incidence of congenital abnormalities reported 2, 3
• No differences in pregnancy complications including cesarean section rates, placenta previa, antepartum hemorrhage, preterm labor, or pregnancy-induced hypertension 2
• No intrauterine deaths attributed to treatment 2

Monitoring and Follow-up

Clinical surveillance schedule:

• Initial assessment at enrollment (5-12 weeks gestation) 4
• Follow-up visits at 6-13 weeks, 8-14 weeks, 18-20 weeks, and 24-26 weeks of gestation 4
• Additional visit at end of treatment (14 weeks) and after delivery 4
• Monitor for resolution of vaginal bleeding and abdominal pain 4

Important Clinical Considerations

Key points for implementation:

• Treatment should be initiated as soon as threatened miscarriage is diagnosed with confirmed viable pregnancy 1, 2
• If bleeding recurs after initial cessation, treatment may be prolonged beyond the standard protocol 4
• Standard supportive care (bed rest) should be provided alongside dydrogesterone therapy 3
• The evidence base consists primarily of randomized controlled trials showing consistent benefit, though larger definitive trials are ongoing 1, 5

Common pitfall to avoid:

• Do not withhold treatment waiting for "more severe" bleeding—early intervention appears most effective 2, 3
• Do not confuse threatened miscarriage with recurrent pregnancy loss, which requires different diagnostic workup and management strategies 2