Recurrent Pregnancy Loss (RPL) Burden in India

Understanding Recurrent Pregnancy Loss

Recurrent pregnancy loss (RPL) is defined as two or more consecutive pregnancy losses occurring before 20 weeks of gestation. This condition has various causes, including genetic abnormalities, uterine anomalies, hormonal disorders, as well as immunological or environmental factors. Globally, RPL affects an estimated 2–4% of individuals in their childbearing years, with a prevalence of approximately 7.4% in India.

Role of Dydrogesterone in RPL Management

Efficacy of Dydrogesterone ER 20 mg

Dydrogesterone ER 20 mg has been recognized as a safe and effective treatment for recurrent early pregnancy loss (REPL), also referred to as RPL. Clinical findings indicate a low miscarriage rate and a high rate of pregnancy continuation beyond 20 weeks of gestation. These results were published in the August 2025 issue of the Indian Journal of Obstetrics and Gynecology Research.

Need for Progesterone Support & Dydrogesterone Advantage in RPL

Importance of Progesterone in Early Pregnancy

Progesterone is essential for maintaining early pregnancy, as it prepares the endometrium for implantation and reduces uterine contractility, thus supporting pregnancy continuation. Dydrogesterone, an orally active progestogen, closely resembles endogenous progesterone and binds selectively to progesterone receptors (PR-A and PR-B) in the uterus. This selectivity minimizes interference with other hormonal pathways, reducing the risk of side effects commonly associated with non-specific receptor activity.

Study Overview

The objective of the study was to evaluate the safety and effectiveness of Dydrogesterone ER 20 mg. This retrospective, multicentric observational study was conducted across 166 healthcare centers in India, involving 828 women with a history of RPL treated with Dydrogesterone ER 20 mg. Patient data were collected using standardized Case Report Forms (CRFs), focusing on outcomes such as miscarriage incidence, pregnancy continuation, and adverse events.

Patient Demographics

The mean age of patients participating in the study was 29.8 ± 4.52 years, with a mean gestational age at the initiation of treatment of 7.17 ± 1.7 weeks. On average, patients had experienced 2.37 ± 0.97 prior pregnancy losses. Most patients (86.1%) received Dydrogesterone ER 20 mg once daily, while 12.8% received it twice daily, and 1.1% were prescribed it three times daily.

Key Results from the Study

Miscarriage Rate and Pregnancy Continuation

A significant finding from the study was that 84.3% of patients received concomitant supplements, with 22.1% receiving progesterone support and 21% using antithrombotic agents. The miscarriage rate was recorded at 7.7% (n=64), while an impressive 92.3% (n=764) of patients continued their pregnancies beyond 20 weeks.

Safety Profile

Adverse events were reported in 9.3% of patients (n=77), predominantly mild in nature (80%). Common adverse events included nausea, headache, acidity, and vomiting. Notably, 93% of these adverse events resolved completely.

Conclusion

The current study concluded that Dydrogesterone ER 20 mg demonstrates a favorable safety profile and clinically significant effectiveness for Indian women experiencing recurrent early pregnancy loss. The low miscarriage rate and high treatment tolerability support its potential as a reliable therapeutic option in managing RPL.

References

Purandare AC, Jhaveri R, Marathe V, Goswami R, Chauhan R, Jaiswal A, Shetty B. Real-world evaluation of safety and effectiveness of Dydrogesterone 20mg extended release in the management of recurrent early pregnancy loss. Indian J Obstet Gynecol Res. 2025;12(3):475–479.