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Oral Dydrogesterone Shows No Significant Benefit in Preventing Preterm Birth: Meta-Analysis
Egypt: A recent systematic review and meta-analysis published in BMC Pregnancy and Childbirth has found limited evidence supporting the use of oral dydrogesterone in preventing preterm birth, highlighting the need for more robust clinical trials before it can be routinely recommended.
Preterm birth continues to be a leading cause of neonatal illness and death globally, prompting ongoing research into preventive therapies. Oral dydrogesterone, a synthetic progestin, has been used in certain clinical settings for this purpose, although its effectiveness remains uncertain.
To address this gap, Sohieb Hedawy from the Faculty of Medicine at Al-Azhar Assiut University, Egypt, and colleagues conducted a systematic review and meta-analysis to assess the efficacy and safety of oral dydrogesterone compared to placebo in pregnant women at risk of preterm delivery. The study followed PRISMA guidelines and included only randomized controlled trials, excluding observational and non-randomized studies to ensure methodological rigor.
The researchers performed a comprehensive search across major databases, including PubMed, Cochrane Library, Web of Science, and Scopus, covering studies published up to December 2024. The quality of the included trials was evaluated using the Cochrane Risk of Bias tool. Statistical analyses were conducted using a random-effects model, while the certainty of evidence was assessed using the GRADE framework. Additionally, trial sequential analysis (TSA) was applied to determine whether the available data were sufficient to draw firm conclusions.
The following were the key findings:
- The analysis included five randomized controlled trials with a total of 436 participants.
- Oral dydrogesterone showed a slight increase in gestational age at delivery compared to placebo, but this was not statistically significant.
- A non-significant reduction in NICU admissions was observed in the dydrogesterone group.
- No meaningful differences were noted between the two groups for other maternal or neonatal outcomes.
- Most outcomes were supported by low to very low certainty evidence, reflecting substantial uncertainty.
- Trial sequential analysis indicated that the available evidence is underpowered and insufficient for definitive conclusions.
- Overall, the observed trends, though somewhat favorable, remain inconclusive and not fully reliable.
Overall, the study concludes that oral dydrogesterone does not demonstrate a statistically or clinically significant benefit in preventing preterm birth or improving related maternal and neonatal outcomes when compared to placebo. Given the low certainty of evidence and inconclusive results, the authors emphasize that dydrogesterone should not be recommended for routine clinical use in this context at present.
The researchers highlight the urgent need for larger, well-designed randomized controlled trials to better evaluate the role of oral dydrogesterone in preterm birth prevention and to inform future clinical guidelines.
Reference:
Hedawy, S., Aldalahmeh, S., Labeeb, E.E. et al. Effectiveness of oral dydrogesterone compared to placebo in reducing the risk of preterm birth: a systematic review and meta-analysis. BMC Pregnancy Childbirth 26, 222 (2026). https://doi.org/10.1186/s12884-026-08747-5
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