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

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)

Study Overview

• Status: Recruiting
• Conditions: Recurrent Miscarriage; Antiphospholipid Syndrome
• Intervention / Treatment: Drug: Enoxaparin; Drug: Warfarin

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohamed I Eid, Dr; Phone Number: +201225401274; Email: dr_moh_eid@yahoo.com

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35111
      • Recruiting
      • Obstetrics and Gynecology Department in Mansoura University Hospital
      • Contact: Mohamed I Eid, Dr; Phone Number: +201225401274; Email: dr_moh_eid@yahoo.com
    • Mansourah, Dakahlia, Egypt
      • Recruiting
      • Private practice settings

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enoxaparin group; Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy	Drug: Enoxaparin; Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC); Other Names: Clexan
Active Comparator: Warfarin group; Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester	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; Other Names: Marevan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm delivery	Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency	From 20 weeks to 34 weeks gestational age
Intrauterine growth restriction (IUGR)	Birth weight less than the 10th percentile for gestational age	At birth
Congenital fetal malformations	Congenital fetal malformations	At birth

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mohamed Sayed Abdelhafez
• Investigators: Principal Investigator: Mohamed I Eid, Dr, Mansoura University; Study Chair: Abdelmageed F Mashaly, Prof, Mansoura University; Study Director: Mohamed S Abdelhafez, Dr, Mansoura University

Publications and helpful links

General Publications

• Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimated): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Antiphospholipid syndrome; APS; Warfarin
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Syndrome; Abortion, Spontaneous; Abortion, Habitual; Antiphospholipid Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Warfarin
• Other Study ID Numbers: MIE1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No