GIVING women who have suffered a miscarriage a hormone in their next pregnancy could save the lives of 4,700 babies ever year, a new study suggests.
Women who suffer bleeding during their first weeks of pregnancy could improve their chances of having a baby by taking progesterone, experts said.
PA:Press Association3 Progesterone could be given to women who have miscarried to help them get pregnant, researchers say
The team from the University of Birmingham said an estimated 4,700 babies' lives per year in the UK could be saved.
They carried out a trial on 4,153 pregnant women who presented early pregnancy bleeding at 48 UK hospitals.
Expectant mums were randomly assigned by computer into one of two groups – one group of 2,079 women who were given 400mg of progesterone twice daily as a vaginal pessary, while the other group of 2,074 were given a placebo.
While the study did not show that progesterone could help all women who suffered early pregnancy bleeding, it was found to help those who had suffered a previous miscarriage.
This treatment could save thousands of babies who may have otherwise been lost to a miscarriage
Arri Coomarasamyprofessor of gynaecology at the University of Birmingham
Of the 777 women given progesterone who had previously had one or two miscarriages, 591 (76 per cent) went on to have a live birth, compared with 534 women out of 738 in the placebo group (72 per cent).
The benefit was greater for the women who had suffered three or more miscarriages, with a 15 per cent increase in the live birth rate in the progesterone group compared with the placebo group.
Of 137 women with three or more previous miscarriages, 98 (72 per cent) went on to have a live birth, compared with 57 per cent (85 out of 148) of women in the placebo group.
The PRISM trial, which was funded by the National Institute for Health Research (NIHR) and published in the New England Journal of Medicine, was the largest of its kind.
Mum's baby joy after taking part in trial
A mother has spoken of her joy at having a son after taking part in a clinical trial on miscarriage.
Samantha Allen, 31, from Bradford, West Yorkshire, suffered a miscarriage in December 2015 and was recruited to the PRISM trial in June 2017 when she was nine weeks pregnant.
She and her husband Stephen, 36, welcomed son Noah in February 2018.
"It was on my birthday in November 2015 when I found out that I was pregnant – it was the best birthday gift I could have hoped for," she said.
"However, my joy soon started to turn to concern when I began having some bleeding when I was around seven weeks pregnant and I ended up in A&E.
"I had a scan and was told to come back on Christmas Eve for another scan.
"But then, on December 23, I started bleeding quite heavily and had to call an ambulance.
"I was taken to A&E where I was told the baby had died when I was eight weeks pregnant and I was miscarrying.
"The following day, on Christmas Eve, I had to also go through the trauma of miscarriage surgery."
Around 15 months later she found out she was pregnant again, but after seven weeks she began spotting and decided to go to the early pregnancy unit.
She had a scan and was told they could detect a heartbeat but couldn't be certain so she was booked for a scan two weeks later.
Samantha continued: "The spotting continued during those two weeks so I was relieved when the second scan showed I was pregnant.
"That's when they told me about the PRISM trial and I decided to take part.
"I was prescribed progesterone pessaries which I self-administered until I was 16 weeks pregnant.
"The bleeding stopped within a week of starting the trial."
Noah was born weighing a healthy 9lb 6oz and is now 14-months-old.
She concluded: "Of course, we'll never know whether or not I would have miscarried if I had not taken part in the trial, or if I had been part of the group that received the placebo.
"Either way, I feel fortunate and happy that I did participate.
"I hope the results of the trial will make a difference to the way women receive treatment moving forwards, and that I had a small part to play in that."
Arri Coomarasamy, professor of gynaecology at the University of Birmingham and director of Tommy's National Centre for Miscarriage Research, said: "The role of progesterone in women with early pregnancy bleeding has been studied and debated for about 60 years, however what we have previously lacked is high-quality evidence.
"The largest study before the PRISM trial had less than 200 participants, whereas our study had more than 4,000 participants and was of very high quality, which means we can be confident in our findings.
Parents now have a robust and effective treatment option which will save many lives and prevent much heartache
Jane BrewinTommy's Charity CEO
"Our finding that women who are at risk of a miscarriage because of current pregnancy bleeding and a history of a previous miscarriage could benefit from progesterone treatment has huge implications for practice.
"This treatment could save thousands of babies who may have otherwise been lost to a miscarriage.
"We hope that this evidence will be considered by the National Institute for Health and Care Excellence (Nice) and that it will be used to update national guidelines for women at risk of miscarriage."
Jane Brewin, chief executive of the Tommy's baby charity, said: "The results from this study are important for parents who have experienced miscarriage – they now have a robust and effective treatment option which will save many lives and prevent much heartache.
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"It gives us confidence to believe that further research will yield more treatments and ultimately make many more miscarriages preventable."
Dr Adam Devall, senior clinical trial fellow at the University of Birmingham and manager of Tommy's National Centre for Miscarriage Research, said: "Miscarriage is a common complication of pregnancy, affecting one in five women, and vaginal bleeding in early pregnancy is associated with a one in three risk of miscarriage.
"Several small studies have suggested that administering progesterone, a hormone essential for maintaining a pregnancy, may reduce the risk of miscarriage in women presenting with early pregnancy bleeding."
Samantha Allen3 Samantha Allen holding baby Noah, who she had after taking part in the trial
Samantha Allen3 Noah was born in February 2018 weighing 9lbs 6oz
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