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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome

NCT01068795

Fetal Demise Fetal Growth Restriction Preeclampsia +2 more

COMPLETED NA

Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

NCT01660061

Antiphospholipid Syndrome

COMPLETED

Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy

NCT01758640

Anticoagulation in Pregnancy

COMPLETED PHASE3

Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss

NCT02385461

Pregnancy Complications

UNKNOWN

Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves

NCT02240927

Pregnancy Heart; Complications, Valve, Prosthesis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Miscarriage Antiphospholipid Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enoxaparin group

Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

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

Warfarin group

Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enoxaparin

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

Intervention Type DRUG

Warfarin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clexan Marevan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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