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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

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)

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
Study Start Date : December 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 2017

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Arm Intervention/treatment
Active Comparator: Early Enoxaparin initiation
Women will start Enoxaparin therapy once positive pregnancy test is established
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

Active Comparator: Later Enoxaparin initiation
Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Fetal loss [ Time Frame: From 20 weeks to 42 weeks gestational age ]
    Unexplained fetal death of morphologically normal fetus after the first trimester

  2. 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

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

  4. 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): NCT02326051


Locations
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Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital
Mansourah, Dakahlia, Egypt, 35111
Private practice settings
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 Director: Waleed El-refaie, Dr Mansoura University
Study Director: Ahmed El-Zayadi, Dr Mansoura University
Study Chair: Ahmed Badawy, Prof Mansoura University

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Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02326051     History of Changes
Other Study ID Numbers: MIE2
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Antiphospholipid syndrome
APS
LMWH
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Antiphospholipid Syndrome
Syndrome
Disease
Pathologic Processes
Pregnancy Complications
Autoimmune Diseases
Immune System Diseases