Micronized progesterone use for miscarriage: discussion questions of clinical trials
Keywords:luteal phase insufficiency, threatened miscarriage, recurrent miscarriage, vaginal progesterone
Recurrent miscarriage is defined by two or more consecutive unsuccessful clinical pregnancies and occurs in 1–3% of couples. It is caused by a chromosomal abnormality, anatomical factors, including cervical incompetence, antiphospholipid syndrome and hereditary thrombophilia, immune, endocrine, and infectious causes.
The purpose of this review is to summarize published studies on the clinical aspects of the vaginal progesterone use in women with threatened miscarriage and recurrent miscarriage.
Indications for progesterone drugs use for the threatened abortion are: habitual miscarriage, luteal phase deficiency, pregnancy and infertility cured, which came as a result of assisted reproductive technology. It is intended that serum progesterone level is not a diagnostic criterion for evaluation of the luteal phase deficiency in connection with impulse hormone secretion.
A systematic review and meta-analysis of randomized controlled trials published in recent years comparing the use of vaginal progesterone to placebo or no treatment for the prevention of preterm birth and improve neonatal outcomes in singleton gestation and a short cervix. But the evidence is the progestogens use for the threatened miscarriage and recurrent miscarriage is still insufficient.
Results of a meta-analysis perfumed Wahabi H.A. et al. that united the 4 studies, have confirmed that progestogen is effective in the treatment of threatening miscarriage without an increase in the incidence of fetus congenital anomalies. However, data in this meta-analysis were combined various gestagens (progesterone, dydrogesterone), regardless of the dose, duration, and method of application.
Described the significant limitations of randomized placebo-controlled trial PROMISE, which do not adequately assess the potential reduction in risk of miscarriage during progesterone use.
Conducting a large randomized double-blind placebo-controlled multi-centre trial PRISM involving 4150 women for study progesterone effectiveness in reducing miscarriage rates in women with early pregnancy bleeding, the results of which are expected in 2018, gives hope to receive objective data.
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