Preconceptional Thromboprophylaxis in Recurrent PREGNANCY LOSSES Caused by Antiphospholipid Syndrome

• Conditions: Recurrent Pregnancy Losses; Positive Anti Phospholipid Syndrome
• Interventions: Drug: low molecular weight heparin (enoxeparine)

• Registration Number: NCT01661439
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 316

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low molecular weight heparin	low molecular weight heparin (enoxeparine)	SC LMWH IN patients with recurrent pregnancy loss

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Women Health Hospital; 🇪🇬 Assiut, Egypt