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Preconceptional Thromboprophylaxis in Recurrent PREGNANCY LOSSES Caused by Antiphospholipid Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01661439
First received: July 25, 2012
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

Preconceptional use of low molecular weight heparin 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 Intervention
Recurrent Pregnancy Losses
Positive Anti Phospholipid Syndrome
 Drug: low molecular weight heparin (enoxeparine)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Clinical Trial of Using Preconceptional Low Molecular Heparin AND OR Low Dose Asprin in Patient With Antiphospholipid Syndrome(APS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • Pregnancy continuation beyond twelve weeks gestation [ Time Frame: ONE YEAR ] [ Designated as safety issue: Yes ]
    giving low molecular weight heparin 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


Enrollment: 267
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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.

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661439

Locations
Egypt
Women Health Hospital
Assiut, Egypt
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
  More Information

No publications provided

Responsible Party: alaa eldeen mahmoud ismail, MD, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01661439     History of Changes
Other Study ID Numbers: PCTRPL, preconceptional heparin in APS
Study First Received: July 25, 2012
Last Updated: August 8, 2012
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013