Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OBGYN_SPIN_01
Study information
Scientific title
Acronym
SPIN
Study hypothesis
Does treatment with low dose aspirin and Low Molecular Weight Heparin (LMWH) in women with consecutive recurrent pregnancy loss(es) at less than/equal to 24 weeks gestation (and no evidence of anatomical, endocrine, chromosomal or immunological abnormality) result in a reduction in the rate of expected loss in the index pregnancy from 25% to 15% or less?
Please note that as of 13/11/2007 the funding by the Chief Scientist Office was extended from 31/05/2007 to the 31/12/2008 for this trial. The end date of this trial has been changed to reflect this.
Ethics approval
Ethics approval received from the North West Multicentre Research Ethics Committee (MREC) on the 30th September 2003 (ref: MREC 03/8/041)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Recurrent miscarriage
Intervention
Low Molecular Weight Heparin, aspirin and intense surveillance versus intense surveillance only.
Medications given as follows: enoxaparin 40 mg subcutaneously, once per day by self injection and 75 mg aspirin orally once daily. Medications are prescribed at randomisation and stop at 36 weeks gestation.
Intervention type
Drug
Phase
Not Specified
Drug names
Aspirin, low molecular weight heparin (LMWH)
Primary outcome measure
Live birth rate (delivery of a live infant beyond 37 weeks of gestation).
Secondary outcome measures
1. Preterm delivery of a live infant (between 28 and 37 weeks of gestation)
2. Obstetric complications (pregnancy associated hypertension, pre-eclampsia, intrauterine growth retardation)
3. Congenital malformations
4. Admission to special care
5. Side-effects of the drug used, both for the mother and the baby
6. Thromboembolic complications
Overall trial start date
01/06/2004
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Have a history of a minimum of two consecutive early pregnancy losses (defined as at/or before 24 weeks gestation)
2. Present at less than or equal to 7 weeks gestation with a positive pregnancy test and confirmatory ultrasound
3. Give written informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant exclusion criteria
1. A previous foetal loss has been associated with an anatomical, chromosomal,(maternal/paternal) endocrine or immunological cause
2. They have a previous history of venous or arterial thrombosis
3. They are already known to have antiphospholipid syndrome (as defined by the presence of an antiphospholipid antibody and three consecutive early pregnancy failures)
4. At enrolment are already known to have a thrombophilic disorder
5. They have a history of three or more pregnancy losses and are found or are already known to have a positive lupus inhibitor screen or Immunoglobulin G (IgG)/Immunoglobulin M (IgM) anticardiolipin antibodies above the local reference range
6. Are found to have an excluding condition on booking for the current pregnancy such as anaemia requiring therapy, platelets less than 150 x 10^12/l, abnormal thyroid function, multiple or rare red cell alloantibodies or auto-antibodies
7. Known hypersensitivity to the active substance or any of the excipients
Recruitment start date
01/06/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Scottish National Blood
Dundee
DD1 9SY
United Kingdom
Funders
Funder type
Government
Funder name
Scottish Executive, Health Department, Chief Scientist Office (UK) (Ref: CZB/4/110)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20237316
Publication citations
-
Results
Clark P, Walker ID, Langhorne P, Crichton L, Thomson A, Greaves M, Whyte S, Greer IA, , SPIN (Scottish Pregnancy Intervention) study: a multicenter, randomized controlled trial of low-molecular-weight heparin and low-dose aspirin in women with recurrent miscarriage., Blood, 2010, 115, 21, 4162-4167, doi: 10.1182/blood-2010-01-267252.