Antiphospholipid syndrome in pregnancy: A controlled treatment trial
| ISRCTN | ISRCTN55179279 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55179279 |
| Protocol serial number | RHC18084 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive North West (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 12/01/2010
- 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 Roy Farquharson
Scientific
Scientific
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
| Phone | +44 (0)151 708 9988 |
|---|---|
| Roy.Farquharson@lwh-tr.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the efficacy of low dose heparin in the treatment of antiphospholipid antibody syndrome during pregnancy, comparing low dose aspirin with low dose aspirin combined with low molecular weight heparin, in women suffering from recurring pregnancy loss. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy; antiphospholipid antibody syndrome |
| Intervention | 1. Aspirin 2. Aspirin and low molecular weight heparin |
| Intervention type | Other |
| Primary outcome measure(s) |
Live birth rate in both arms of the trial (defined as the live birth rate after 24 weeks gestation). |
| Key secondary outcome measure(s) |
The secondary outcome measures will concern maternal morbidity, e.g. osteoporosis, and fetal parameters, such as premature delivery and the incidence for "small for dates". |
| Completion date | 01/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 98 |
| Key inclusion criteria | Pregnant women with antiphospholipid antibody syndrome |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 01/01/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
L8 7SS
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 | 01/09/2002 | Yes | No |
