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

NCT01051778 | Completed Phase 2 Results DMC

• 1 other identifier: Aps/UFH/enox40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Recurrent Abortion

Keywords

Recurrent abortion; Antiphospholipid syndrome; unfractionated heparin; Low Molecular Weight Heparin

Outcome Measures

Primary Outcomes (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.

  pregnancy > 24weeks gestation

Secondary Outcomes (6)

• Minor and Major Bleeding

  Duration of pregnancy and puerperium

• Thrombocytopenia

  Duration of pregnancy and puerperium

• Preeclampsia

  Pregnancy > 20 weeks gestation

• IUFD

  Pregnancy >24 weeks gestation

• Preterm Delivery

  24 weeks gestation<Pregnancy <37weeks gestation

Study Arms (2)

enoxaparin 40 mg plus low dose aspirin

EXPERIMENTAL

Drug: enoxaparin 40mg plus low dose aspirin

Heparin calcium 5,000 U twice daily plus low dose aspirin

ACTIVE COMPARATOR

Drug: Heparin calcium5,000 U twice daily plus low dose aspirin

Interventions

enoxaparin 40mg plus low dose aspirin DRUG

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.

Also known as: Clexane 40 mg

enoxaparin 40 mg plus low dose aspirin

Heparin calcium5,000 U twice daily plus low dose aspirin DRUG

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 .

Also known as: Cal-Heparine

Heparin calcium 5,000 U twice daily plus low dose aspirin

Eligibility Criteria

• Age: 19 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Ahmed Elgazzar Hospital: collaborator

Study Sites (2)

Ahmed Elgazzar hospital

Cairo, Egypt

Location

Cairo university hospital

Cairo, Egypt

Location

Related Publications (4)

• 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.

  PMID: 15749498 BACKGROUND

• 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.

  PMID: 15307977 BACKGROUND

• 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.

  PMID: 32358837 DERIVED

• 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.

  PMID: 21251653 DERIVED

MeSH Terms

Conditions

Abortion, Habitual; Antiphospholipid Syndrome

Interventions

Enoxaparin; Aspirin

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Usama .M .Fouda
• Organization: Cairo university

umfrfouda@yahoo.com

+20123595106

Study Officials

• Usama M Fouda

  Lecturer of obstetrics and Gynecology , Cairo university

  PRINCIPAL INVESTIGATOR

• Ahmed M Sayed

  Assistant professor of obstetrics and Gynecology , Cairo university.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 20, 2010
• Study Start: June 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 29, 2011
• Results First Posted: August 29, 2011

Record last verified: 2010-01

Locations

EG (2)