Dydrogesterone Oral: Duration During Pregnancy
Dydrogesterone should be continued until 20 weeks of gestation in women receiving it for threatened miscarriage, recurrent pregnancy loss, or luteal phase support, then discontinued. 1
Evidence-Based Duration Guidelines
Standard Duration: Up to 20 Weeks Gestation
The established practice for dydrogesterone in pregnancy is continuation through the first trimester and into early second trimester, typically until 20 weeks of gestation. 1
This duration aligns with the physiological transition when placental progesterone production becomes fully autonomous and corpus luteum support is no longer required. 1
The 20-week endpoint is supported by decades of clinical use showing no maternal complications or congenital anomalies linked to dydrogesterone usage during early pregnancy. 2
Dosing Regimens During Pregnancy
For threatened or recurrent miscarriage: Dydrogesterone 10 mg twice daily (BID) is the traditional regimen, though newer sustained-release formulations allow 20 mg once daily (OD). 1, 3
For luteal phase support during assisted reproductive techniques: Dydrogesterone 10 mg BID or 20-30 mg SR once daily, continued through first trimester. 4, 3
Real-world data shows average prescription duration of dydrogesterone 20 mg SR is 55.50 ± 31.33 days, while 30 mg SR averages 79.66 ± 68.38 days. 3
Safety Profile Supporting This Duration
Post-marketing surveillance over 60 years demonstrates a favorable safety profile with no increase in congenital anomalies when dydrogesterone is used during early pregnancy. 2
Unlike other progestogens, dydrogesterone lacks estrogenic, androgenic, glucocorticoid, or anabolic effects, making it suitable for use throughout pregnancy when indicated. 4, 5
Studies evaluating dydrogesterone use for up to 260 weeks (in non-pregnant contexts) show minimal adverse events, supporting its safety during the shorter pregnancy exposure period. 2
Clinical Decision Algorithm
Step 1: Confirm indication
- Threatened miscarriage with bleeding
- History of recurrent pregnancy loss (≥2 prior losses)
- Luteal phase support following ART
- Documented progesterone deficiency 4
Step 2: Initiate appropriate dose
- Standard: 10 mg BID (total 20 mg/day)
- Alternative: 20 mg SR once daily for improved compliance
- High-risk cases: 30 mg SR once daily 3
Step 3: Continue through critical period
- Maintain therapy through first trimester (weeks 1-13)
- Extend into early second trimester (weeks 14-20)
- Target discontinuation at 20 weeks gestation 1
Step 4: Taper or abrupt discontinuation
- No evidence supports gradual tapering over abrupt cessation
- Discontinue at 20 weeks when placental progesterone production is established 1
Common Pitfalls to Avoid
Do not continue dydrogesterone beyond 20 weeks of gestation—there is no evidence of benefit and it unnecessarily prolongs medication exposure. 1, 2
Do not use dydrogesterone as a progestogen component of menopausal hormone therapy during pregnancy—it is contraindicated in pregnancy when used for HRT indications. 1
Do not assume all progestogens have equivalent safety profiles—dydrogesterone's unique molecular structure (retroprogesterone) and lack of androgenic effects distinguish it from synthetic progestins. 4, 5
Special Considerations
For women with prior recurrent miscarriage, dydrogesterone may be initiated preconceptionally and continued through 20 weeks once pregnancy is confirmed. 4
In assisted reproductive technology cycles, dydrogesterone is effective as luteal phase support and should be continued from embryo transfer through 20 weeks gestation. 4, 2
The once-daily sustained-release formulations (20 mg or 30 mg SR) offer improved compliance compared to twice-daily dosing, with 89.48% of prescriptions for 20 mg SR and 64.06% for 30 mg SR using OD regimens. 3