Table 2.
Dydrogesterone in threatened pregnancy loss.
| Rate of PL | ||||||
|---|---|---|---|---|---|---|
| RCT | Dydrogesterone Treatment | Control Treatment | Dydrogesterone | Control or Untreated Group | RR/OR (95% CI) |
p Value |
| [76] | Dydrogesterone 40 mg, followed by 10 mg BID (n = 74) until bleeding stopped, or conservative therapy with bed rest and folic acid | All women received bed rest and folic acid (n = 80) | 4.1% | 13.8% | – | p = 0.037 |
| [77] | Standard supportive care and dydrogesterone 10 mg BID (n = 86) until 1 week after bleeding stopped | All women received standard supportive care a (n = 60) | 17.5% | 25.0% | – | p < 0.05 |
| [78] | Dydrogesterone 40 mg (stat dose), followed by 10 mg BID (n = 96) until Week 16 | Conservative management with bed rest only (n = 95) | 12.5% | 28.4% | – | p < 0.05 |
| [79] | Dydrogesterone 10 mg BID (n = 71) for 2 weeks | Oral micronized progesterone 200 mg BID (n = 70) for 2 weeks | 15.2% | 10.2% | – | p = 0.581 |
| [80] | Dydrogesterone 40 mg (stat dose), followed by 10 mg TID (n = 203) until Week 12 or 1 week after cessation of bleeding | Placebo (n = 203) | 12.8% | 14.3% | RR: 0.897 (0.548–1.467) |
p = 0.772 |
| Rate of PL | ||||||
| Meta-Analysis | Dataset | Main Result | Dydrogesterone | Control |
RR/OR (95% CI) |
p Value |
| [67] | Dydrogesterone vs. placebo or conservative treatment Five studies (n = 660) |
Significant b reduction in the miscarriage rate with dydrogesterone | 13.0% | 24.0% | OR: 0.47 (0.31–0.70) |
NA b |
| [6] | Dydrogesterone vs. control (conservative treatment) Three studies (n = 491) |
Significant reduction in the miscarriage rate with dydrogesterone | 11.7% | 22.6% | OR: 0.43 (0.26–0.71) |
p = 0.001 |
| Vaginal progesterone vs. control (placebo or conservative treatment) Four studies (n = 286) |
Decrease in the miscarriage rate with vaginal progesterone (not significant) | 15.4% | 20.3% | OR: 0.72 (0.39–1.34) |
p = 0.3 | |
| [3] | Oral progestogen vs. no treatment Three studies (n = 408); dydrogesterone two studies (n = 337) |
Significant reduction in the miscarriage rate with oral progestogens (including dydrogesterone) | NA | NA | RR: 0.57 (0.38–0.85) |
p = 0.0059 |
| Vaginal progesterone vs. placebo Four studies (n = 288) |
Little or no treatment effect with vaginal progesterone | NA | NA | RR: 0.75 (0.47–1.21) |
p = 0.24 | |
| [54] | Progestogens vs. placebo or no treatment Ten studies (n = 5104); dydrogesterone vs. placebo or no treatment, four studies (n = 563) |
Oral progestogens may have benefits on rates of PL: benefit only seen with oral progestogen and not with vaginal progesterone | 18.5% | 21.9% | RR: 0.73 (0.59–0.92) |
p = 0.01 |
| [57] | Progestogens vs. other progesterone treatment or placebo 59 studies (n = 10,424); dydrogesterone vs. other progesterone treatment or placebo, 49 studies (n = 2793) |
Dydrogesterone significantly reduced the risk of miscarriage vs. vaginal, IM, and oral micronized progesterone or placebo | NA | NA | Vaginal OR: 0.50 (0.34–0.74) |
p = 0.002 |
| IM OR: 0.41 (0.32–0.54) |
p = 0.006 | |||||
| Oral OR: 0.37 (0.28–0.48) |
p < 0.001 | |||||
| Placebo OR: 0.42 (0.29–0.61) |
p < 0.001 | |||||
a Iron, folic acid, multivitamin supplements, and recommended bed rest; bp value not stated. BID, twice daily; CI, confidence interval; IM, intramuscular; NA, not applicable; OR, odds ratio; PL, pregnancy loss; RCT, randomized clinical trial; RR, risk ratio; TID, three times daily.