Timing of Initiation of LMWH Administration in Pregnant Women With APS

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

Tracking Information

• First Submitted Date: December 22, 2014
• First Posted Date: December 25, 2014
• Last Update Posted Date: November 29, 2017
• Study Start Date: December 2014
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT02326051 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: 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: Timing of Initiation of LMWH Administration in Pregnant Women With APS
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Recurrent Miscarriage
• Antiphospholipid Syndrome

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2017): 100
• Original Estimated Enrollment (submitted: December 22, 2014): 150
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 38 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT02326051
• Other Study ID Numbers: MIE2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Mohamed Sayed Abdelhafez, Mansoura University
• Study Sponsor: Mohamed Sayed Abdelhafez
• Collaborators: Not Provided

Investigators

• 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