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.

The trial is now complete.

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.

Participants were able to take part in the trial if a blood test showed that they had inherited thrombophilia and:

• They'd had two or more miscarriages
• They were aged between 18 and 42
• They were trying for a baby, or plan to try, and are not yet pregnant and
• They were willing to be ‘randomised’ – to be chosen at random – to either the trial treatment 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.

The following hospitals took part in the trial:

England

• Basingstoke: Basingstoke and North Hampshire Hospital
• Birmingham: Heartlands Hospital
• Birmingham: Birmingham Women's Hospital
• Bolton: Royal Bolton Hospital
• Cambridge: Addenbrooke’s Hospital
• Chester: Countess of Chester Hospital
• Chesterfield: Chesterfield Royal Hospital
• Coventry: University Hospital Coventry
• Cumbria: University Hospitals of Morecambe Bay
• Harrogate: Harrogate District Hospital
• Kingston Upon Thames: Kingston Hospital
• Leicester: Leicester Royal Infirmary
• Leeds: St James University Hospital
• Liverpool: Liverpool Women’s Hospital
• London: Epsom and St Helier University Hosptials NHS Trust
• London: North Middlesex University Hospital
• London: Royal Free Hospital
• London: University College London Hospital (UCLH)
• London: University Hospital Lewisham
• Manchester: St Mary’s Hospital
• Manchester: Stepping Hill Hospital
• Nottingham: Queens Medical Centre
• Oxford: John Radcliffe Hospital
• Sheffield: Jessop Wing (Royal Hallamshire Hospital)
• Southampton: University Hospital Southampton
• Tameside and Glossop: Tameside General Hospital
• Wirral: Arrowe Park Hospital

Scotland

• Ayrshire and Arran: University Hospital Crosshouse

Wales

• Swansea: Singleton Hospital

For current participants

Thank you for taking part in the ALIFE2 study. For information on your data privacy please access the following page: https://www.uhcw.nhs.uk/privacy/.

Enquiries:

 
Email: alife2@warwick.ac.uk

You can also read about the trial results on the Tommy's website - News Item