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

Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02303171

Enrollment

100

Registered

2014-11-27

Start date

2014-11-30

Completion date

2025-06-30

Last updated

2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid Syndrome, Recurrent Miscarriage

Keywords

Antiphospholipid syndrome, APS, Warfarin

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.

Interventions

DRUGEnoxaparin

Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)

DRUGWarfarin

Women will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 38 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Hemorrhagic complications	After 12 weeks gestational age up to birth	Hemorrhagic complications
Thromboembolic complications	After 12 weeks gestational age up to birth	Thromboembolic complications

Countries

Egypt

Contacts

Primary ContactMohamed I Eid, Dr

dr_moh_eid@yahoo.com+201225401274

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026