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Progesterone therapy fails to prevent miscarriage
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A significantly higher rate of live births among women with a history of miscarriages was not found with the use of progesterone supplements, according to recent study findings.
“The findings of the PROMISE trial are bound to come as a disappointment to many thousands of women and couples affected by miscarriage,” Arri Coomarasamy, MBChB, MD, of Birmingham Women's Hospital in the United Kingdom, told Endocrine Today. “They will be especially disheartening to those with repeated miscarriages for which specialist investigations have shown no obvious cause. Many hoped that this research would confirm progesterone as an effective treatment to increase the chance of a baby next time. Sadly, it does not.”
Arri Coomarasamy
Coomarasamy and colleagues evaluated data from the PROMISE trial on 826 women who conceived naturally within 1 year to determine whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among those with a history of unexplained recurrent miscarriages. Women were randomly assigned to progesterone 400 mg twice-daily vaginal suppositories (n = 398) or placebo (n = 428) shortly after a positive urinary pregnancy test and no later than 6 weeks gestation through 12 weeks gestation.
Rates of live births were similar after 24 weeks gestation between the two groups (progesterone group, 65.8%; placebo, 63.3%). The rates of clinical pregnancy (at 6 to 8 weeks), ongoing pregnancy (at 12 weeks), ectopic pregnancy, miscarriage and stillbirth; neonatal outcomes; and median gestational age at miscarriage did not significantly differ between the two groups.
Overall, there were 533 pregnancies that progressed to live birth after 24 weeks in the whole study population. Rates of deliveries before 34 weeks gestation were similar between the two groups (progesterone, 3.8%; placebo, 3.7%).
“There are some important positive messages to take away from the study,” Coomarasamy said. “Whether they received progesterone or placebo, nearly two-thirds of the women participants in the trial had their much wanted baby. That means there is still a good chance of a healthy pregnancy after unexplained recurrent miscarriage without any treatment at all. The trial results also showed that there were no negative side effects of progesterone treatment for women or for their babies. That is very important for women taking progesterone for other reasons, such as fertility treatment.” – by Amber Cox
Disclosure: Coomarasamy reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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