Recurrent Pregnancy LossHepASANCT00564174
Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
A study testing Low molecular weight heparin and low dose aspirin and Low dose aspirin in people with Recurrent Pregnancy Loss and Antiphospholipid Antibody Syndrome, run by Mount Sinai Hospital, Canada at 2 sites in Canada.
Trial summary
To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Antiphospholipid Antibody Syndrome
- What is being tested?
- Low molecular weight heparin and low dose aspirin and Low dose aspirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2000to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- history of two or more unexplained consecutive pregnancy losses prior to 32 weeks
- presence of one of the panel of autoantibodies/thrombophilia markers
- confirmed pregnancy
Who cannot join
- SLE
- known peptic ulcer disease
- sensitivity to ASA or heparin
- previous thrombotic event
- geographic distance from clinic
- failure to consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Medical Centre
Hamilton, Ontario
Mount Sinai Hosptial
Toronto, Ontario, M5G 1X5
About this study
Official title: A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.
Read the detailed description
Previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. We undertook a RCT of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.
- Being tested
- Low molecular weight heparin and low dose aspirin, Low dose aspirin
- Keywords
- recurrent pregnancy loss, lupus anticoagulant, anti cardiolipin antibodies, thrombophilia, low molecular weight heparin, aspirin, randomized clinical trial
- Medical subject headings
- Antiphospholipid Syndrome, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparin and low dose aspirinDrug
Also called Fragmin (Dalteparin Sodium), ASA
Fragmin 5000 IU/day by subcutaneous injection started at time of randomization and continued until 35 weeks gestation or delivery and low dose aspirin 81 mg/day started pre-conception and continued until 35 weeks gestation or delivery
Low dose aspirinDrug
Also called ASA
81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
| Study group | Role | What they receive |
|---|---|---|
| a | Experimental | Not described Receives: Drug: Low molecular weight heparin and low dose aspirin |
| b | Active comparator | Low dose aspirin only Receives: Drug: Low dose aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.
Measured: Duration of pregnancy
Secondary outcomes (1)
Secondary outcomes included adverse events and incidence of bone loss in the two groups.
Measured: pre-pregnancy through postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startMar 2000
- Study completionSep 2005
Why it stopped: interim analysis found no difference in LB rate and lower than expected event rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Investigators
- Carl A Laskin, MD, Principal investigator, Associate Professor, Department of Medicine, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564174
- Sponsor's protocol ID
- 33762
- Other IDs
- CIHR 37749
- Acronym
- HepASA
- Status last verified
- Nov 2007
- First submitted
- 26 Nov 2007
- Last updated
- 27 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
PubMed 32358837
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT00564174
- Acronym / sponsor ID
- HepASA / 33762
- Keywords
- recurrent pregnancy loss, lupus anticoagulant, anti cardiolipin antibodies, thrombophilia, low molecular weight heparin, aspirin, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis found no difference in LB rate and lower than expected event rate
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Study start
- Mar 2000
- Study completion
- Sep 2005 (actual)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.
Detailed description
Previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. We undertook a RCT of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a | Experimental | Drug: Low molecular weight heparin and low dose aspirin |
| b | Active comparator | Drug: Low dose aspirinLow dose aspirin only |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- history of two or more unexplained consecutive pregnancy losses prior to 32 weeks
- presence of one of the panel of autoantibodies/thrombophilia markers
- confirmed pregnancy
Key exclusion criteria (6 listed)
- SLE
- known peptic ulcer disease
- sensitivity to ASA or heparin
- previous thrombotic event
- geographic distance from clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low molecular weight heparin and low dose aspirinAlso: Fragmin (Dalteparin Sodium), ASAFragmin 5000 IU/day by subcutaneous injection started at time of randomization and continued until 35 weeks gestation or delivery and low dose aspirin 81 mg/day started pre-conception and continued until 35 weeks gestation or delivery | Drug | a |
| Low dose aspirinAlso: ASA81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery | Drug | b |
Primary outcome
To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.
Time frame: Duration of pregnancy
1 secondary outcome
Secondary outcomes included adverse events and incidence of bone loss in the two groups.
Time frame: pre-pregnancy through postpartum period
Results and safety
The study was stopped early (reason given: interim analysis found no difference in LB rate and lower than expected event rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
- Derived from this study: PubMed 32358837Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl A Laskin, MD principal investigator
Associate Professor, Department of Medicine, University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low molecular weight heparin and low dose aspirin and Low dose aspirin in people with Recurrent Pregnancy Loss and Antiphospholipid Antibody Syndrome, run by Mount Sinai Hospital, Canada at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: interim analysis found no difference in LB rate and lower than expected event rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (time frame: Duration of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00564174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2007.