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Timing of Initiation of LMWH Administration in Pregnant Women With APS

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ClinicalTrials.gov Identifier: NCT02326051
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Tracking Information
First Submitted Date  ICMJE December 22, 2014
First Posted Date  ICMJE December 25, 2014
Last Update Posted Date November 29, 2017
Study Start Date  ICMJE December 2014
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
Ongoing pregnancy rate [ Time Frame: After 12 weeks gestational age ]
Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02326051 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
  • Fetal loss [ Time Frame: From 20 weeks to 42 weeks gestational age ]
    Unexplained fetal death of morphologically normal fetus after the first trimester
  • 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 Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 22, 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 Same as current
 
Descriptive Information
Brief Title  ICMJE Timing of Initiation of LMWH Administration in Pregnant Women With APS
Official Title  ICMJE Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
Brief Summary Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)
Detailed Description Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Recurrent Miscarriage
  • Antiphospholipid Syndrome
Intervention  ICMJE
  • Drug: Enoxaparin
    Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy
    Other Name: Clexan
  • Drug: Enoxaparin
    Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy
    Other Name: Clexan
Study Arms  ICMJE
  • Active Comparator: Early Enoxaparin initiation
    Women will start Enoxaparin therapy once positive pregnancy test is established
    Intervention: Drug: Enoxaparin
  • Active Comparator: Later Enoxaparin initiation
    Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation
    Intervention: Drug: Enoxaparin
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2017)
100
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2014)
150
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date February 2017   (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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326051
Other Study ID Numbers  ICMJE MIE2
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 Director: Waleed El-refaie, Dr Mansoura University
Study Director: Ahmed El-Zayadi, Dr Mansoura University
Study Chair: Ahmed Badawy, Prof Mansoura University
PRS Account Mansoura University
Verification Date November 2017

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