Use of Warfarin After the First Trimester in Pregnant Women With APS

Phase 4

Recruiting

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

• Registration Number: NCT02303171
• Lead Sponsor: Mohamed Sayed Abdelhafez

Brief Summary

Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)

Detailed Description

Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• 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
Enoxaparin group	Enoxaparin	Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy
Warfarin group	Warfarin	Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester

Primary Outcome Measures

Name	Time	Method
Fetal loss	From 12 weeks to 42 weeks gestational age	Unexplained fetal death of morphologically normal fetus after the first trimester

Secondary Outcome Measures

Name	Time	Method
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
Intrauterine growth restriction (IUGR)	At birth	Birth weight less than the 10th percentile for gestational age
Congenital fetal malformations	At birth	Congenital fetal malformations

Trial Locations

Locations (2)

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

Private practice settings; 🇪🇬 Mansourah, Dakahlia, Egypt