Timing of Initiation of LMWH Administration in Pregnant Women With APS
Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
1 other identifier
interventional
100
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2014
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 22, 2014
CompletedFirst Posted
Study publicly available on registry
December 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedNovember 29, 2017
November 1, 2017
2.2 years
December 22, 2014
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy rate
Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women
After 12 weeks gestational age
Secondary Outcomes (4)
Fetal loss
From 20 weeks to 42 weeks gestational age
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)
Early Enoxaparin initiation
ACTIVE COMPARATORWomen will start Enoxaparin therapy once positive pregnancy test is established
Later Enoxaparin initiation
ACTIVE COMPARATORWomen will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation
Interventions
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
Eligibility Criteria
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
Private practice settings
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 22, 2014
First Posted
December 25, 2014
Study Start
December 1, 2014
Primary Completion
February 1, 2017
Study Completion
May 1, 2017
Last Updated
November 29, 2017
Record last verified: 2017-11