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Trial record 52 of 736 for:    warfarin

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

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ClinicalTrials.gov Identifier: NCT02303171
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Tracking Information
First Submitted Date  ICMJE November 25, 2014
First Posted Date  ICMJE November 27, 2014
Last Update Posted Date October 4, 2019
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
Fetal loss [ Time Frame: From 12 weeks to 42 weeks gestational age ]
Unexplained fetal death of morphologically normal fetus after the first trimester
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Fetal loss [ Time Frame: 12 months ]
Unexplained fetal death of morphologically normal fetus after the first trimester
Change History Complete list of historical versions of study NCT02303171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
  • Preterm delivery [ Time Frame: 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) [ Time Frame: At birth ]
    Birth weight less than the 10th percentile for gestational age
  • Congenital fetal malformations [ Time Frame: At birth ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
  • Preterm delivery [ Time Frame: 12 months ]
    Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
  • Intrauterine growth restriction (IUGR) [ Time Frame: 12 months ]
    Birth weight less than the 10th percentile for gestational age
  • Congenital fetal malformations [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2014)
  • Hemorrhagic complications [ Time Frame: After 12 weeks gestational age up to birth ]
  • Thromboembolic complications [ Time Frame: After 12 weeks gestational age up to birth ]
Original Other Pre-specified Outcome Measures
 (submitted: November 25, 2014)
  • Hemorrhagic complications [ Time Frame: 12 months ]
  • Thromboembolic complications [ Time Frame: 12 months ]
 
Descriptive Information
Brief Title  ICMJE Use of Warfarin After the First Trimester in Pregnant Women With APS
Official Title  ICMJE Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Recurrent Miscarriage
  • Antiphospholipid Syndrome
Intervention  ICMJE
  • Drug: Enoxaparin
    Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)
    Other Name: Clexan
  • 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 Name: Marevan
Study Arms  ICMJE
  • Active Comparator: Enoxaparin group
    Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy
    Intervention: Drug: Enoxaparin
  • Active Comparator: Warfarin group
    Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester
    Intervention: Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed I Eid, Dr +201225401274 dr_moh_eid@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02303171
Other Study ID Numbers  ICMJE MIE1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mohamed Sayed Abdelhafez, Mansoura University
Study Sponsor  ICMJE Mohamed Sayed Abdelhafez
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed I Eid, Dr Mansoura University
Study Director: Mohamed S Abdelhafez, Dr Mansoura University
Study Chair: Ahmed M Badawy, Prof Mansoura University
Study Chair: Abdelmageed F Mashaly, Prof Mansoura University
PRS Account Mansoura University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP