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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 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

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)

Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Antiphospholipid Syndrome Drug: Enoxaparin Drug: Warfarin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Study Start Date : November 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019


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 Name: 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 Name: Marevan




Primary Outcome Measures :
  1. Fetal loss [ Time Frame: From 12 weeks to 42 weeks gestational age ]
    Unexplained fetal death of morphologically normal fetus after the first trimester


Secondary Outcome Measures :
  1. 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

  2. Intrauterine growth restriction (IUGR) [ Time Frame: At birth ]
    Birth weight less than the 10th percentile for gestational age

  3. Congenital fetal malformations [ Time Frame: At birth ]

Other Outcome Measures:
  1. Hemorrhagic complications [ Time Frame: After 12 weeks gestational age up to birth ]
  2. Thromboembolic complications [ Time Frame: After 12 weeks gestational age up to birth ]


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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303171


Contacts
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Contact: Mohamed I Eid, Dr +201225401274 dr_moh_eid@yahoo.com

Locations
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Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital Recruiting
Mansourah, Dakahlia, Egypt, 35111
Contact: Mohamed I Eid, Dr    +201225401274    dr_moh_eid@yahoo.com   
Private practice settings Recruiting
Mansourah, Dakahlia, Egypt
Sponsors and Collaborators
Mohamed Sayed Abdelhafez
Investigators
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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

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Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02303171     History of Changes
Other Study ID Numbers: MIE1
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Antiphospholipid syndrome
APS
Warfarin

Additional relevant MeSH terms:
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Syndrome
Antiphospholipid Syndrome
Abortion, Spontaneous
Abortion, Habitual
Disease
Pathologic Processes
Pregnancy Complications
Autoimmune Diseases
Immune System Diseases
Warfarin
Anticoagulants