The Scottish Pregnancy Intervention Study: The effect of low molecular weight heparin and aspirin therapy on recurrent pregnancy loss

ISRCTN	ISRCTN06774126
DOI	https://doi.org/10.1186/ISRCTN06774126
Protocol serial number	OBGYN_SPIN_01
Sponsor	Greater Glasgow Health Board (North Glasgow University Hospitals Division) and Glasgow University (UK)
Funder	Scottish Executive, Health Department, Chief Scientist Office (UK) (Ref: CZB/4/110)

Submission date: 23/08/2005
Registration date: 16/09/2005
Last edited: 07/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Clark
Scientific

Scottish National Blood
Transfusion Service
East of Scotland Blood Transfusion Centre
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SPIN
Study objectives	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(s)	Ethics approval received from the North West Multicentre Research Ethics Committee (MREC) on the 30th September 2003 (ref: MREC 03/8/041)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Aspirin, low molecular weight heparin (LMWH)
Primary outcome measure(s)	Live birth rate (delivery of a live infant beyond 37 weeks of gestation).
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	600
Key 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
Key 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
Date of first enrolment	01/06/2004
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Scottish National Blood

Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/05/2010		Yes	No