ALIFE 2
Research type
Research Study
Full title
Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2
IRAS ID
183481
Contact name
Siobhan Quenby
Contact email
Sponsor organisation
Research, Development & Innovation Department, UHCW NHS Trust
Eudract number
2015-002357-35
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Women who experience recurrent miscarriage are desperate for a treatment to increase their chance of live birth in their next pregnancy. For women with acquired blood clotting disorders, treatment with anticoagulant drugs is effective. Unfortunately, for women with inherited blood clotting disorders, no evidence of such treatment exists. This means that no treatment can be prescribed with the knowledge that the benefits outweigh any side effects.
It is therefore the objective of the ALIFE2 study to evaluate whether an anticoagulant drug (low-molecular-weight heparin) increases the change of a successful pregnancy in women with recurrent miscarriage and inherited blood clotting disorders. Women who participate in the ALIFE2 study will be randomised to receive either treatment with LMWH or to receive standard pregnancy surveillance and supportive care during their next pregnancy. Treatment with LMWH is considered safe in pregnancy for both the mother and the child as it does not cross the placenta, but women who use LMWH may have side effects such as easy bruising or itching at the injection site. Data on the outcome of the pregnancy (live birth or no live birth) as well as pregnancy complications and adverse treatments effects will all be recorded, to study whether LMWH is effective and whether its efficacy outweighs potential side effects.
For the purposes of the ALIFE2 trial recurrent miscarriage will be defined as 2 or more consecutive or non-consecutive miscarriages.Summary of Study Results:
About the ALIFE2 Study Pregnant women with inherited thrombophilia are thought to be more likely to experience complications during their pregnancy, such as pre-eclampsia, slow growth and recurrent miscarriage.
Many clinicians believe that anticoagulant treatments (blood-thinning medicines) could improve outcomes for women with inherited thrombophilia who have experienced multiple miscarriages, but evidence was limited.
The ALIFE2 study aimed to confirm whether anticoagulant treatment can help to prevent further losses in women with inherited thrombophilia and a history of recurrent miscarriage.
Who participated in the study?
400 women with inherited thrombophilia and recurrent miscarriage agreed to take part in the study. 326 became pregnant and were allocated at random to either treatment with heparin (an anticoagulant medicine) or standard care.What treatments or interventions did the participants take/receive?
Participants were randomly allocated into 2 groups. One group (164 participants) received daily heparin injections across the course of their pregnancy, starting from as soon as possible after a positive pregnancy test and ending at the start of labour. The other group (162 participants) did not receive heparin. All women received standard obstetrician-led care and were encouraged to take folic acid.What medical problems (adverse reactions) did the participants have?
As expected, bruising easily was reported by 73 (45%) of women in the group taking heparin (mostly around injection-sites) and only 16 (10%) in the standard care group.What were the results of the study?
The trial showed that daily injection of heparin does not improve the chance of a live birth for women with two or more pregnancy losses and confirmed inherited thrombophilia, when compared to standard care.• 116 women (71.6%) treated with heparin had a baby born alive after 24 weeks’ pregnancy.
• 112 women (70.9%) in the standard care group had a baby born alive after 24 weeks’ pregnancy.The risk of other pregnancy complications, such as miscarriage, babies with low birth weight, placental abruption, premature birth or pre-eclampsia, was about the same for both groups.
How has this study helped patients and researchers?
This study helps patient by providing evidence that they do no need to inject themselves with heparin every day throughout pregnancy. The study help researched by allowing them to focus on mechanisms of miscarriage that do no include blood clotting.
Details of any further research planned:
28% of women who participated in the ALIFE2 trial lost their badly wanted pregnancies, and these unexplained losses will be the focus of further study, as our researchers continue to search for answers and treatment to prevent early pregnancy loss.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0261
Date of REC Opinion
22 Sep 2015
REC opinion
Further Information Favourable Opinion