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Timing of Initiation of LMWH Administration in Pregnant Women With APS

NCT ID: NCT02326051

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-05-31

Brief Summary

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Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)

Detailed Description

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Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy

Conditions

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Recurrent Miscarriage Antiphospholipid Syndrome

Keywords

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Antiphospholipid syndrome APS LMWH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Enoxaparin initiation

Women will start Enoxaparin therapy once positive pregnancy test is established

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy

Later Enoxaparin initiation

Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy

Interventions

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Enoxaparin

Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy

Intervention Type DRUG

Enoxaparin

Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy

Intervention Type DRUG

Other Intervention Names

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Clexan Clexan

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
* Early pregnancy body weight is 50-90 Kg

Exclusion Criteria

* Women with systemic lupus erythematosus (SLE)
* Women with active thromboembolic disorders
* Women with history of previous thromboembolic disorders
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Sayed Abdelhafez

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sayed Abdelhafez

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed I Eid, Dr

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Mohamed S Abdelhafez, Dr

Role: STUDY_DIRECTOR

Mansoura University

Waleed El-refaie, Dr

Role: STUDY_DIRECTOR

Mansoura University

Ahmed El-Zayadi, Dr

Role: STUDY_DIRECTOR

Mansoura University

Ahmed Badawy, Prof

Role: STUDY_CHAIR

Mansoura University

Locations

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Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MIE2

Identifier Type: -

Identifier Source: org_study_id