Timing of Initiation of LMWH Administration in Pregnant Women With APS

Phase 4

Completed

• Conditions: Recurrent Miscarriage; Antiphospholipid Syndrome
• Interventions: Drug: Enoxaparin

• Registration Number: NCT02326051
• Lead Sponsor: Mohamed Sayed Abdelhafez

Brief Summary

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

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-25
• Primary Completion: 2017-02
• Study Completion: 2017-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Enoxaparin initiation	Enoxaparin	Women will start Enoxaparin therapy once positive pregnancy test is established
Later Enoxaparin initiation	Enoxaparin	Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	After 12 weeks gestational age	Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women

Secondary Outcome Measures

Name	Time	Method
Fetal loss	From 20 weeks to 42 weeks gestational age	Unexplained fetal death of morphologically normal fetus after the first trimester
Preterm delivery	From 20 weeks to 34 weeks gestational age	Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
Congenital fetal malformations	At birth
Intrauterine growth restriction (IUGR)	At birth	Birth weight less than the 10th percentile for gestational age

Trial Locations

Locations (2)

Obstetrics and Gynecology Department in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt

Private practice settings; 🇪🇬 Mansourah, Dakahlia, Egypt