Preconceptional Thromboprophylaxis in Recurrent PREGNANCY LOSSES Caused by Antiphospholipid Syndrome

Sponsor

Woman's Health University Hospital, Egypt (Other)

Overall Status

Unknown status

CT.gov ID

NCT01661439

Collaborator

(none)

316

Enrollment

Location

Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Anticipated 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 :

Mar 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	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 Names: clexane,innohep

Arm

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 Names:

clexane,innohep

Outcome Measures

Primary Outcome Measures

Pregnancy continuation beyond twelve weeks gestation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All women with recurrent first-trimester miscarriage and all women with one or more second-trimester miscarriage who screened before pregnancy for antiphospholipid antibodies.
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:

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