Comparison between Oral Dydrogesterone and Oral Micronized Progesterone in Threatened Abortion : A randomized controlled trial

Abortion can be defined as the extraction or expulsion of a foetus or an embryo weighing less than 500 grams at less than 20 weeks period of gestation (WHO and The National Centre of Health Statistics), incapable of independent survival. Abortion is a common outcome occurring in 10-15% of total clinically recognised pregnancies. It can be a devastating event for women leading to stress, depression, anxiety, delay in family completion, economic burden and hence family tension.

Of the many clinical presentations of abortion, at one end we have inevitable abortion which presents with bleeding, cervical dilatation and pain in the abdomen, indicating impending abortion and on the other we have threatened abortion where excluding genetic causes timely intervention can lead to a positive fetomaternal outcome. Threatened abortion presents with spotting per vaginum, with or without abdominal discomfort less than 20 weeks of gestation, with an alive intrauterine fetus. An important prerequisite of threatened abortion is closed internal os in per vaginum examination. Pathogenicity of threatened abortion is multifactorial such as chromosomal anomalies, structural anomalies incompatible with life, infections, uterine anomalies, uncontrolled diabetes, immunological dysfunction like APLA, endocrine factors like levels of thyroid hormone, and absence of adequate progesterone concentration. Decreased progesterone due to dysfunctional corpus luteum is one of the main reasons for threatened abortion. Hence, exogenous progesterone is prescribed as the primary treatment for threatened abortion besides bed rest.

Progesterone is a female sex hormone and as the name suggests is " Pro - Gestation" by aiding implantation, maintaining pregnancy and preventing early contractions of the uterus. Progesterone supplements are available in the form of injections, tablets, capsules and vaginal suppositories. Maximum compliance is noted in the oral route of administration. On the contrary, oral administration of natural progesterone is found less effective as it is highly lipophilic and insoluble in water. In 1980 oral micronized progesterone in the form of suspension of oil came as a boon. It solved the problem of absorption and it lacks the adverse metabolic effects of synthetic progesterone as well. Dydrogesterone is an exogenous synthetic progesterone that is identical to natural synthetic progesterone in structure and pharmacological actions. It doesn’t exhibit androgenic (in the mother) and estrogenic (in the fetus) side effects like other synthetic progestogens in use.

To prevent threatened abortions and to safeguard pregnancy, progesterone has been the choice of drug and is widely prescribed all over. Even so, there is a paucity of studies to manage the condition. As threatened abortion remains one of the important pregnancy outcomes, it’s management requires more evidence-based research. This study compares oral dydrogesterone and oral micronized progesterone in threatened abortion, its efficacy and side effects.