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The first of the studies, published in the American Journal of Obstetrics and Gynecology, assessed the scientific and economic advantages of giving a course of self-administered progesterone to women in the form of pessaries a small soluble block that is inserted into the vagina.
According to the researchers, including those from the University of Birmingham in the UK, the pessaries are provided when the women first present with early pregnancy bleeding up until 16 weeks of pregnancy to prevent miscarriage.
They explained that progesterone, a hormone naturally secreted by the ovaries and placenta in early pregnancy, is vital to the attainment and maintenance of healthy pregnancies.
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In PROMISE, they studied 836 women with unexplained recurrent miscarriages at 45 hospitals in the UK and the Netherlands and found a three percent higher live birth rate with progesterone, but with substantial statistical uncertainty.
PRISM, on the other hand, studied 4,153 women with early pregnancy bleeding at 48 hospitals in the UK, and found there was a 5 percent increase in the number of babies born to those who were given progesterone who had previously had one or more miscarriages compared to those given a placebo.
According to the researchers, progesterone treatment benefitted women who had previous recurrent miscarriages with a 15 percent increase in the live birth rate compared to the placebo group.
The other study, published in BJOG: an International Journal of Obstetrics & Gynaecology, evaluates the economics of the PRISM trial.
It concluded that progesterone is cost-effective, requiring on average of 204 Pounds per pregnancy.
“Between 20 and 25 percent of pregnancies end in a miscarriage, which has a major clinical and psychological impact on women and their families,” said Adam Devall, Senior Clinical Trial Fellow at the University of Birmingham.
“The role of first-trimester progesterone supplementation in the treatment of pregnancies at high risk of miscarriage is a long-standing research question that has been debated in the medical literature for over 60 years,” Devall added.
According to the researchers, women with the dual risk factors of early pregnancy bleeding, and a history of one or more previous miscarriages may benefit from the progesterone treatment.
“Our suggestion is to consider offering to women with early pregnancy bleeding and a history of one or more previous miscarriages a course of treatment of progesterone 400 milligrams twice daily, started at the time of presentation with vaginal bleeding and continued to 16 completed weeks of gestation,” said Arri Coomarasamy, Professor of Gynaecology at the University of Birmingham.
“In the UK, we estimate that implementing this treatment strategy would result in an additional 8,450 live births per year,” he said.