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