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Timing of Initiation of LMWH Administration in Pregnant Women With APS

Primary Purpose

Recurrent Miscarriage, Antiphospholipid Syndrome

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Enoxaparin
Enoxaparin
Sponsored by
Mohamed Sayed Abdelhafez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Miscarriage focused on measuring Antiphospholipid syndrome, APS, LMWH

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Obstetrics and Gynecology Department in Mansoura University Hospital
  • Private practice settings

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early Enoxaparin initiation

Later Enoxaparin initiation

Arm Description

Women will start Enoxaparin therapy once positive pregnancy test is established

Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate
Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women

Secondary Outcome Measures

Fetal loss
Unexplained fetal death of morphologically normal fetus after the first trimester
Preterm delivery
Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
Intrauterine growth restriction (IUGR)
Birth weight less than the 10th percentile for gestational age
Congenital fetal malformations

Full Information

First Posted
December 22, 2014
Last Updated
November 27, 2017
Sponsor
Mohamed Sayed Abdelhafez
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1. Study Identification

Unique Protocol Identification Number
NCT02326051
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Sayed Abdelhafez

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Miscarriage, Antiphospholipid Syndrome
Keywords
Antiphospholipid syndrome, APS, LMWH

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Enoxaparin initiation
Arm Type
Active Comparator
Arm Description
Women will start Enoxaparin therapy once positive pregnancy test is established
Arm Title
Later Enoxaparin initiation
Arm Type
Active Comparator
Arm Description
Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Clexan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Clexan
Intervention Description
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
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women
Time Frame
After 12 weeks gestational age
Secondary Outcome Measure Information:
Title
Fetal loss
Description
Unexplained fetal death of morphologically normal fetus after the first trimester
Time Frame
From 20 weeks to 42 weeks gestational age
Title
Preterm delivery
Description
Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
Time Frame
From 20 weeks to 34 weeks gestational age
Title
Intrauterine growth restriction (IUGR)
Description
Birth weight less than the 10th percentile for gestational age
Time Frame
At birth
Title
Congenital fetal malformations
Time Frame
At birth
Other Pre-specified Outcome Measures:
Title
Hemorrhagic complications
Time Frame
After 12 weeks gestational age up to birth
Title
Thromboembolic complications
Time Frame
After 12 weeks gestational age up to birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed I Eid, Dr
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed El-Zayadi, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Badawy, Prof
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Obstetrics and Gynecology Department in Mansoura University Hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Facility Name
Private practice settings
City
Mansourah
State/Province
Dakahlia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Timing of Initiation of LMWH Administration in Pregnant Women With APS

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