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Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT (HepASA)

Primary Purpose

Recurrent Pregnancy Loss, Antiphospholipid Antibody Syndrome

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Low molecular weight heparin and low dose aspirin

Low dose aspirin

About this trial

This is an interventional treatment trial for Recurrent Pregnancy Loss focused on measuring recurrent pregnancy loss, lupus anticoagulant, anti cardiolipin antibodies, thrombophilia, low molecular weight heparin, aspirin, randomized clinical trial

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

SLE
known peptic ulcer disease
sensitivity to ASA or heparin
previous thrombotic event
geographic distance from clinic
failure to consent

Sites / Locations

McMaster Medical Centre
Mount Sinai Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Low dose aspirin only

Outcomes

Primary Outcome Measures

To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.

Secondary Outcome Measures

Secondary outcomes included adverse events and incidence of bone loss in the two groups.

Full Information

NCT ID

NCT00564174

First Posted

November 26, 2007

Last Updated

November 26, 2007

Sponsor

Mount Sinai Hospital, Canada

Collaborators

Canadian Institutes of Health Research (CIHR), Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00564174

Brief Title

Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT

Acronym

HepASA

Official Title

A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Terminated

Why Stopped

interim analysis found no difference in LB rate and lower than expected event rate

Study Start Date

March 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mount Sinai Hospital, Canada

Collaborators

Canadian Institutes of Health Research (CIHR), Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Pregnancy Loss, Antiphospholipid Antibody Syndrome

Keywords

recurrent pregnancy loss, lupus anticoagulant, anti cardiolipin antibodies, thrombophilia, low molecular weight heparin, aspirin, randomized clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Description

Low dose aspirin only

Intervention Type

Drug

Intervention Name(s)

Low molecular weight heparin and low dose aspirin

Other Intervention Name(s)

Fragmin (Dalteparin Sodium), ASA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Low dose aspirin

Other Intervention Name(s)

ASA

Intervention Description

81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Secondary outcomes included adverse events and incidence of bone loss in the two groups.

Time Frame

pre-pregnancy through postpartum period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

44 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: SLE known peptic ulcer disease sensitivity to ASA or heparin previous thrombotic event geographic distance from clinic failure to consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl A Laskin, MD

Organizational Affiliation

Associate Professor, Department of Medicine, University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

McMaster Medical Centre

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

Mount Sinai Hosptial

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

32358837

Citation

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.

Results Reference

derived

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Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT

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