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ALIFE

 

Anticoagulants for LIving FEtus

 

Inclusion completed in January 2008.

Follow-up ongoing; study medication in first pregnancy after inclusion still necessary.

 

 

A randomized placebo controlled trial for women with recurrent miscarriage without an apparent cause.

 

Go to the ALIFE webpage: www.amc.nl/alife

ALIFE documents: www.alifestudie.nl

 

Background

Recurrent miscarriage is defined as two or more (not necessarily consecutive) miscarriages.  Unexplained recurrent miscarriage requires the following diagnostic tests to be normal: chromosome analysis in the couple, anatomy of the uterine cavity, homocysteine level and antiphospholipid syndrome should be excluded.

There is reasonable evidence to suggest that some cases of unexplained recurrent miscarriage are associated with placental thrombosis. Also inherited thrombophilias have been associated with recurrent miscarriage. Evidence of good methodological studies that anticoagulants can improve the live birth rate of women with unexplained recurrent miscarriage, with or without inherited thrombophilias, is lacking.

 

Objective

Our aim is to assess the efficacy of two different anticoagulant strategies, as compared with placebo, on the live-birth rate in women with unexplained recurrent miscarriage, with or without an inherited thrombophilia.

 

Study design

A randomized prospective multicentre open label trial, double blinded  and placebo controlled for Aspirin.

 

Population

Women under 43 years of age with an history of two or more miscarriages without an apparent cause with or without inherited thrombophilias and trying to conceive or pregnant not beyond 6 weeks of gestational age are eligible for this trial.

 

Intervention and follow-up

The three intervention groups are as follows: placebo and Aspirin are double blinded, the third group is open label and combines Aspirin with low molecular weight heparin (LMWH). Placebo and Aspirin are packed in identical sachets and favourably started preconceptionally and continued until 36 weeks of gestation. In the third group, Aspirin will be combined with LMWH (Fraxiparine 2850 EH/day) as soon as a vital intrauterine pregnancy is diagnosed. LMWH will be continued throughout the pregnancy until 12 hours before labour. During pregnancy antenatal care will be provided by the participantís own gynaecologist. For the detailed description please refer to the flow-chart on www.alifestudie.nl.

 

Outcome measures and analysis

The primary outcome will be live-birth rate.

Secondary outcomes are adverse pregnancy outcomes (like pre-eclampsia / HELLP syndrome/ intra uterine growth restriction) and thromboembolic complications.

 

Analysis will be performed according the intention to treat principle. Live-birth rates of all three intervention groups will be expressed with their 95% confidence intervals. To detect a difference in live-birth rate of 15% between the intervention group with LMWH and the group without LMWH and using an alpha of 5% and a beta of 20%, 103 pregnancies in each group are needed. Taken into account that 5-6 % of the women trying to conceive will not get pregnant we aim to randomize 350 participants.

 

Participating hospitals

Amsterdam:   Academic Medical Centre

Amsterdam:   Onze Lieve Vrouwe Gasthuis

Enschede:   Medisch Spectrum Twente

Groningen:   University Medical Centre Groningen

Maastricht:   Academic Hospital Maastricht

Breda:   Amphia Hospital

Veldhoven:   Maxima Medical Centre

 

Contact information

research fellow:  Stef Kaandorp, MD

tel 020-5669111, pager 58220

email:   alife@amc.nl

mobile: 06-43947456