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Recurrent AbortionPhase 2NCT01051778

Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome

A Phase 2 study testing enoxaparin 40mg plus low dose aspirin and Heparin calcium5,000 U twice daily plus low dose aspirin in people with Recurrent Abortion, run by Cairo University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS). Read more about this study

Who is it for?
Ages 19 to 37 years, women only
Conditions the study is for
Recurrent Abortion
What is being tested?
enoxaparin 40mg plus low dose aspirin and Heparin calcium5,000 U twice daily plus low dose aspirin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesEgypt
Study dates
Jun 2006to Dec 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 to 37 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with a minimum of three consecutive pregnancy losses before 10 weeks gestation
  • Positive lupus anticoagulant and/or anticardiolipin antibodies (IgG and IgM) on at least two occasions twelve weeks apart .
  • Age between 19 - 37 years,
  • Body mass index between 19-30

Who cannot join

  • Parental chromosomal abnormalities
  • Uterine abnormalities
  • Luteal phase defect
  • Systemic lupus erythematosus
  • Previous thromboembolism
  • Sensitivity to aspirin.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Ahmed Elgazzar hospital

    Cairo

  • Cairo university hospital

    Cairo

Other trials in Egypt

About this study

Official title: Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial

The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).

Read the detailed description

Women with antiphospholipid syndrome (APS) have live birth rates as low as 10% in pregnancies without pharmacological treatment. Low dose aspirin (LDA) ,unfractionated heparin(UFH) , Low molecular weight heparin (LMWH) , prednisone, and intravenous immunoglobulin (IVIG) have been used either alone or in combination in order to improve the live birth rate in APS positive women with recurrent miscarriage. A Cochrane review of 13 randomized or quasi-randomized, controlled trials of various management options of pregnant women with a history of pregnancy loss and APL, revealed that combined UFH and aspirin was the treatment of choice which reduced pregnancy loss by 54% .

During the past decade , low molecular weight heparins were widely used in the prophylaxis and treatment of patients with venous or arterial thrombosis ,with an efficacy and safety superior or at least equivalent to that of UFH .Although recent studies reported the use of LMWH in the management of patients recurrent pregnancy loss secondary to antiphospholipid syndrome resulted in encouraging results . It is not clear whether the efficacy and safety of LMWH is equivalent to that of UFH .

Although LMWH is more expensive than UFH . LMWH has longer half life , greater bioavailability , more stable dose-response relationship than UFH and therefore can be administered once daily. Furthermore, LMWH requires less frequent monitoring than UFH and and has less adverse effect on bone mineral density and platelet count .These advantages make LMWH more attractive for the patients and physicians than UFH .

There are only two studies which compared the efficacy of LMWH plus LDA with that of UFH plus LDA in the management of pregnant women with recurrent pregnancy loss secondary to APS. In addition ,no randomized controlled study has yet compared the efficacy of LMWH plus LDA with UFH plus LDA.

The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).

Being tested
enoxaparin 40mg plus low dose aspirin, Heparin calcium5,000 U twice daily plus low dose aspirin
Keywords
Recurrent abortion, Antiphospholipid syndrome, unfractionated heparin, Low Molecular Weight Heparin
Medical subject headings
Abortion, Habitual, Antiphospholipid Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enoxaparin 40mg plus low dose aspirinDrug

    Also called Clexane 40 mg

    Enoxaparin 40mg/day by subcutaneous injection ( Clexane 40 mg, Aventis international, Sanofi-aventis France ) is started when the serum pregnancy test become positive. Enoxaparin is stopped 2 days before planned induction of labor or cesarean section and twice-daily unfractionated heparin (UFH) is initiated. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop enoxaparin or UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID)) is started before conception and continued until 36 weeks gestation.

  • Heparin calcium5,000 U twice daily plus low dose aspirinDrug

    Also called Cal-Heparine

    Heparin Calcium 5,000 U twice daily (Cal-Heparine, Amoun Pharmaceutical Co, Egypt) by subcutaneous injection is started when the serum pregnancy test become positive. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID))is started before conception and continued until 36 weeks gestation .

Study groups in NCT01051778
Study groupRoleWhat they receive
enoxaparin 40 mg plus low dose aspirinExperimentalNot described
Receives: Drug: enoxaparin 40mg plus low dose aspirin
Heparin calcium 5,000 U twice daily plus low dose aspirinActive comparatorNot described
Receives: Drug: Heparin calcium5,000 U twice daily plus low dose aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)

    Live birth occurs when a fetus (> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.

    Measured: pregnancy > 24weeks gestation

Secondary outcomes (6)

  1. Minor and Major Bleeding

    Measured: Duration of pregnancy and puerperium

  2. Thrombocytopenia

    Measured: Duration of pregnancy and puerperium

  3. Preeclampsia

    Measured: Pregnancy > 20 weeks gestation

  4. IUFD

    Measured: Pregnancy >24 weeks gestation

  5. Preterm Delivery

    Measured: 24 weeks gestation<Pregnancy <37weeks gestation

  6. Spontaneous Osteoporotic Fractures

    Measured: Duration of pregnancy and puerperium

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2010 (estimated)
  2. Study startJun 2006
  3. Primary completionNov 2009
  4. Study completionDec 2009

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01051778
Sponsor's protocol ID
Aps/UFH/enox40
Status last verified
Jan 2010
First submitted
19 Jan 2010
Last updated
29 Aug 2011
Data monitoring committee
Yes

Publications

  • Noble LS, Kutteh WH, Lashey N, Franklin RD, Herrada J. Antiphospholipid antibodies associated with recurrent pregnancy loss: prospective, multicenter, controlled pilot study comparing treatment with low-molecular-weight heparin versus unfractionated heparin. Fertil Steril. 2005 Mar;83(3):684-90. doi: 10.1016/j.fertnstert.2004.11.002.

    PubMed 15749498

  • Stephenson MD, Ballem PJ, Tsang P, Purkiss S, Ensworth S, Houlihan E, Ensom MH. Treatment of antiphospholipid antibody syndrome (APS) in pregnancy: a randomized pilot trial comparing low molecular weight heparin to unfractionated heparin. J Obstet Gynaecol Can. 2004 Aug;26(8):729-34. doi: 10.1016/s1701-2163(16)30644-2.

    PubMed 15307977

  • 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

  • Fouda UM, Sayed AM, Abdou AM, Ramadan DI, Fouda IM, Zaki MM. Enoxaparin versus unfractionated heparin in the management of recurrent abortion secondary to antiphospholipid syndrome. Int J Gynaecol Obstet. 2011 Mar;112(3):211-5. doi: 10.1016/j.ijgo.2010.09.010. Epub 2011 Jan 19.

    PubMed 21251653

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing enoxaparin 40mg plus low dose aspirin and Heparin calcium5,000 U twice daily plus low dose aspirin in people with Recurrent Abortion, run by Cairo University at 2 sites in Egypt.

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 4 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: finished, as of the sponsor's last update on 29 Aug 2011. 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 Egypt. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (time frame: pregnancy > 24weeks gestation). 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 NCT01051778, which also lists 4 linked publications.

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 29 Aug 2011.

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