Real-World Outcomes of Dydrogesterone ER 20 mg in Recurrent Pregnancy Loss
Recurrent Pregnancy Loss (RPL) Burden in India
Recurrent pregnancy loss (RPL) is defined as two or more consecutive pregnancy losses before 20 weeks of gestation and has multifactorial causes, including genetic abnormalities, uterine anomalies, hormonal disorders, and immunological or environmental factors. It is an obstetric condition estimated to affect 2–4% of childbearing individuals globally. In India, the prevalence of recurrent miscarriage is around 7.4%.
Role of Dydrogesterone in RPL Management
Dydrogesterone ER 20 mg has been found to be safe and effective in the management of recurrent early pregnancy loss (REPL) also known as Recurrent pregnancy loss (RPL), showing a low miscarriage rate and a high rate of pregnancy continuation beyond 20 weeks.
The findings are published in the August 2025 issue of the Indian Journal of Obstetrics and Gynecology Research.
Need for Progesterone Support & Dydrogesterone Advantage in RPL
Progesterone plays a crucial role in maintaining early pregnancy by preparing the endometrium for implantation and reducing uterine contractility, thereby supporting the continuation of pregnancy. Dydrogesterone is an orally active progestogen similar to endogenous progesterone having a high affinity towards progesterone receptors. Dydrogesterone exerts its effects through selective binding to progesterone receptors (PR-A and PR-B) in the uterus, closely mimicking the action of natural progesterone. This selectivity minimizes interference with other hormonal pathways, thereby reducing the risk of side effects commonly associated with non-specific receptor activity.
The objective of the study was to evaluate the safety and the effectiveness of Dydrogesterone ER 20 mg.
This was a retrospective, multicentric, observational study conducted across 166 healthcare centres in India, including 828 women with a history of RPL treated with dydrogesterone ER 20 mg. Patient data were collected using standardized Case Report Forms (CRFs), and outcomes included miscarriage incidence, pregnancy continuation, and adverse events.
The mean patient age was 29.8 ± 4.52 years, and the mean gestational age at treatment initiation was 7.17 ± 1.7 weeks. Patients had an average of 2.37 ± 0.97 prior pregnancy losses.
Most patients (86.1%) received dydrogesterone ER 20 mg once daily (OD); 12.8% received it twice daily (BD), and 1.1% three times daily (TID).
The key results from the study include:
Miscarriage Rate and Pregnancy Continuation
- Most patients received concomitant supplements (84.3%), progesterone support (22.1%), or antithrombotic agents (21%).
- Miscarriage occurred in 7.7% of patients (n=64), while 92.3% (n=764) continued pregnancy beyond 20 weeks.
Figure 1: Incidence of miscarriage before 20 weeks of gestation
Safety Profile
- Adverse events occurred in 9.3% of patients (n=77), mostly mild (80%).
- Common events: nausea, headache, acidity, vomiting. (Figure 2)
- 93% of adverse events resolved completely.
Figure 2: Distribution of reported adverse events
The current study reported that Dydrogesterone ER 20 mg demonstrated a favorable safety profile and clinically meaningful effectiveness in Indian women with recurrent early pregnancy loss. The low miscarriage rate and high treatment tolerability support its role as a reliable therapeutic option in RPL management.
Adapted from:
1) 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
