Preconceptional Thromboprophylaxis in Recurrent PREGNANCY LOSSES Caused by Antiphospholipid Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661439
Recruitment Status : Unknown
Verified March 2012 by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt.
Recruitment status was:  Recruiting
First Posted : August 9, 2012
Last Update Posted : June 23, 2014
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

Brief Summary:
Preconceptional use of low molecular weight heparin (enoxaparin) and aspirin in patient with recurrent miscarriages with positive anti phospholipid antibodies increase the implantation rate and the duration of pregnancy with low complications to the mother and the baby.

Condition or disease Intervention/treatment
Recurrent Pregnancy Losses Positive Anti Phospholipid Syndrome Drug: low molecular weight heparin (enoxeparine)

Detailed Description:
Preconceptional heparin during follicular or luteal phase,improves the implantation rate by increasing the blood flow and increasing the implantation factors,also decreasing the pregnancy complication resulting from Antiphospholipid Syndrome (APS).

Study Type : Observational
Estimated Enrollment : 316 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Clinical Trial of Using Preconceptional Enoxaparin AND Low Dose Aspirin 81mg in Patient With Antiphospholipid Syndrome(APS)
Study Start Date : March 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Group/Cohort Intervention/treatment
Low molecular weight heparin
SC LMWH IN patients with recurrent pregnancy loss
Drug: low molecular weight heparin (enoxeparine)
1mg/kg enoxeparine SC daily from 1st day of the menstrual cycle and continue daily throughout the pregnancy after documentation of pregnancy,and stopped in absence of fetal cardiac activity.
Other Name: clexane,innohep

Primary Outcome Measures :
  1. Pregnancy continuation beyond twelve weeks gestation [ Time Frame: ONE YEAR ]
    giving low molecular weight heparin (enoxaparin) and 81 mg aspirin in patients with positive anti phospholipid antibodies with history of recurrent miscarriages or intrauterine fetal deaths in the preconceptional period one month before pregnancy with follow up as regarding the clinical pregnancy rate,the rate of continuation of pregnancy beyond 28 weeks gestation and the complications related to long term use of heparin and the severity of complication of APS in comparison to the traditional use of anticoagulant after documentation of the fetal heart rate

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with recurrent pregnancy losses either two or more recurrent miscarriages or intrauterine fetal deathes after 20 weeks of gestation with positive antiphospholipid antibodies in medium to high titer in two occasions 6 weeks apart.

Inclusion Criteria:

  1. All women with recurrent first-trimester miscarriage and all women with one or more second-trimester miscarriage who screened before pregnancy for antiphospholipid antibodies.
  2. To diagnose antiphospholipid syndrome it is mandatory that the woman has two positive tests at least 12 weeks apart for either lupus anticoagulant or anticardiolipin antibodies of immunoglobulin G and/or immunoglobulin M class present in a medium or high titre over 40 g/l or ml/l,or above the 99th percentile).

In the detection of lupus anticoagulant, the dilute Russell's viper venom time test together with a platelet neutralisation procedure is more sensitive and specific than either the activated partial thromboplastin time test or the kaolin clotting time test. Anticardiolipin antibodies are detected using a standardised enzyme linked immunosorbent assay.

Exclusion Criteria:

  1. Age above forty years old .
  2. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  3. Fibroids distorting uterine cavity .
  4. Abnormal parental karyotype .
  5. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01661439

Contact: Alaa Mahmoud Ismail, M.D +201000459514
Contact: Hassan salah Kamel, M.D +201006623455

Women Health Hospital Recruiting
Assiut, Egypt
Contact: HASSAN S KAMEL, MD    +2010066436   
Principal Investigator: Alaa M Ismail, MD         
Sponsors and Collaborators
Woman's Health University Hospital, Egypt

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: alaa eldeen mahmoud ismail, MD, Woman's Health University Hospital, Egypt Identifier: NCT01661439     History of Changes
Other Study ID Numbers: PCTRPL
preconceptional heparin in APS
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: March 2012

Keywords provided by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt:
Recurrent miscarriages
recurrent pregnancy loss
anti coagulants in pregnancy

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Abortion, Spontaneous
Fetal Death
Abortion, Habitual
Pathologic Processes
Pregnancy Complications
Autoimmune Diseases
Immune System Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action