NCT02303171

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

10.1 years

First QC Date

November 25, 2014

Last Update Submit

October 27, 2023

Conditions

Recurrent MiscarriageAntiphospholipid Syndrome

Keywords

Antiphospholipid syndromeAPSWarfarin

Outcome Measures

Primary Outcomes (1)

  • Fetal loss

    Unexplained fetal death of morphologically normal fetus after the first trimester

    From 12 weeks to 42 weeks gestational age

Secondary Outcomes (3)

  • Preterm delivery

    From 20 weeks to 34 weeks gestational age

  • Intrauterine growth restriction (IUGR)

    At birth

  • Congenital fetal malformations

    At birth

Other Outcomes (2)

  • Hemorrhagic complications

    After 12 weeks gestational age up to birth

  • Thromboembolic complications

    After 12 weeks gestational age up to birth

Study Arms (2)

Enoxaparin group

ACTIVE COMPARATOR

Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy

Drug: Enoxaparin

Warfarin group

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

EnoxaparinDRUG

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

Also known as: Clexan
Enoxaparin group
WarfarinDRUG

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

Also known as: Marevan
Warfarin group

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Women with systemic lupus erythematosus (SLE)
  • Women with active thromboembolic disorders
  • Women with history of previous thromboembolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32358837DERIVED

MeSH Terms

Conditions

Abortion, HabitualAntiphospholipid Syndrome

Interventions

EnoxaparinWarfarin

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mohamed I Eid, Dr

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Mohamed S Abdelhafez, Dr

    Mansoura University

    STUDY DIRECTOR

  • Abdelmageed F Mashaly, Prof

    Mansoura University

    STUDY CHAIR

Central Study Contacts

Mohamed I Eid, Dr

CONTACT

+201225401274dr_moh_eid@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)