Timing of Initiation of LMWH Administration in Pregnant Women With APS

Mohamed Sayed Abdelhafez100 enrolled

Overview

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)

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Recurrent Miscarriage Antiphospholipid Syndrome

Interventions

EnoxaparinDRUG

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

EnoxaparinDRUG

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 38 Years

Medical Language ↔ Plain English

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

Locations (2)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Ongoing pregnancy rate

Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women

Time frame: After 12 weeks gestational age

Secondary Outcomes

Fetal loss

Unexplained fetal death of morphologically normal fetus after the first trimester

Time frame: From 20 weeks to 42 weeks gestational age

Preterm delivery

Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency

Time frame: From 20 weeks to 34 weeks gestational age

Intrauterine growth restriction (IUGR)

Birth weight less than the 10th percentile for gestational age

Time frame: At birth

Congenital fetal malformations

Time frame: At birth

Data from ClinicalTrials.gov

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