Condition category
Pregnancy and Childbirth
Date applied
23/08/2005
Date assigned
16/09/2005
Last edited
07/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Clark

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Greater Glasgow Health Board (North Glasgow University Hospitals Division) and Glasgow University (UK)

Sponsor details

Divisional Headquarters
300 Balgrayhill Road
Glasgow
G21 3UR
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20237316

Publication citations

  1. 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.

Additional files

Editorial Notes