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 |
| Secondary identifying numbers | OBGYN_SPIN_01 |
- 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
Scientific
Scottish National Blood
Transfusion Service
East of Scotland Blood Transfusion Centre
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2004 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
Scottish National Blood
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
Greater Glasgow Health Board (North Glasgow University Hospitals Division) and Glasgow University (UK)
Hospital/treatment centre
Hospital/treatment centre
Divisional Headquarters
300 Balgrayhill Road
Glasgow
G21 3UR
Scotland
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Government
Scottish Executive, Health Department, Chief Scientist Office (UK) (Ref: CZB/4/110)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
