Dydrogesterone 20 mg ER safe and effective in managing recurrent early pregnancy loss: Study
Recurrent early pregnancy loss (REPL), also known as recurrent pregnancy loss (RPL) is defined as two or more consecutive pregnancy losses before 20 weeks of gestation. It has multifactorial causes, including genetic abnormalities, uterine anomalies, hormonal disorders, and immunological or environmental factors. REPL significantly impacts emotional and psychological well-being, often leading to anxiety and depression.
The management of REPL involves a range of strategies tailored to address underlying causes. Globally, hormonal treatments like progesterone supplementation are widely used, especially for luteal phase defects. In India, treatment options align with global practices but also consider local healthcare capacities, emphasizing progesterone therapy, surgical correction of uterine anomalies, and managing endocrine disorders to improve pregnancy outcomes. 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. However, challenges like poor bioavailability, systemic side effects, and variability in patient responses have limited the efficacy of some progesterone formulations.
Dydrogesterone is a synthetic progestogen that has gained prominence in the management of REPL. It was developed as a synthetic alternative to natural progesterone, aiming to provide similar therapeutic benefits without the side effects associated with progestogens. By promoting decidualization of the endometrium, dydrogesterone transforms the uterine lining into a receptive state for embryo implantation, ensuring optimal conditions for early pregnancy. Additionally, dydrogesterone supports pregnancy maintenance by stabilizing the uterine lining during the luteal phase, preventing premature shedding, and fostering a favorable environment for embryo development. Unlike other progestogens, dydrogesterone is devoid of androgenic or estrogenic effects, making it a safer and more tolerable option for managing recurrent early pregnancy loss.
This was a retrospective, multicentric, observational study conducted from the data obtained of patients with history of REPL treated with dydrogesterone 20 mg ER at the discretion of treating physician. Patient data were collected using standardized Case Report Forms (CRFs), and outcomes included miscarriage incidence, pregnancy continuation, and adverse events. Data were analyzed to evaluate the safety, and effectiveness of dydrogesterone 20 mg ER.
The study included data of 828 patients with history of REPL and treated with dydrogesterone 20 mg ER. The analysis reported an incidence of miscarriage in 64 patients (7.7%), with the majority of patients (92.3%) continuing pregnancy beyond 20 weeks of gestation. Among patients who experienced miscarriage (n=64), the mean gestational age at the time of visit was 6.88 ± 2.12 weeks and at the time of miscarriage was found to be 10.62 ± 3.17 weeks. A total of 77 (9.3%) patients developed adverse events during the treatment period and among them 80% of the adverse events were mild in nature.
Dydrogesterone 20mg ER has demonstrated a favorable safety profile over its extensive clinical use, with adverse events being predominantly mild and transient. This study demonstrated the effectiveness of dydrogesterone 20 mg ER in managing REPL, with a fewer incidence of miscarriage reported among the patient population.
Dydrogesterone 20 mg ER demonstrates effectiveness and safety in managing REPL, with a low incidence of miscarriage. This real-world study supports its role as a practical therapeutic option, offering significant benefits for women with recurrent miscarriages. While promising, further prospective research is necessary to validate these findings and explore long-term outcomes for maternal and neonatal health.
Source: Purandare et al. / Indian Journal of Obstetrics and Gynecology Research 2025;12(3):475–479
