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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01661439
Other study ID # PCTRPL
Secondary ID preconceptional
Status Recruiting
Phase N/A
First received July 25, 2012
Last updated June 20, 2014
Start date March 2012
Est. completion date June 2014

Study information

Verified date March 2012
Source Woman's Health University Hospital, Egypt
Contact Alaa Mahmoud Ismail, M.D
Phone +201000459514
Email dr.alaa_ismail@yahoo.com
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 316
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Women Health Hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy continuation beyond twelve weeks gestation 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 ONE YEAR Yes
See also
  Status Clinical Trial Phase
Completed NCT00456118 - Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Terminated NCT01688284 - The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage N/A