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Use of Warfarin After the First Trimester in Pregnant Women With APS

Primary Purpose

Recurrent Miscarriage, Antiphospholipid Syndrome

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Enoxaparin
Warfarin
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, Warfarin

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 HospitalRecruiting
  • Private practice settingsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enoxaparin group

Warfarin group

Arm Description

Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy

Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester

Outcomes

Primary Outcome Measures

Fetal loss
Unexplained fetal death of morphologically normal fetus after the first trimester

Secondary Outcome Measures

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
November 25, 2014
Last Updated
April 6, 2023
Sponsor
Mohamed Sayed Abdelhafez
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1. Study Identification

Unique Protocol Identification Number
NCT02303171
Brief Title
Use of Warfarin After the First Trimester in Pregnant Women With APS
Official Title
Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

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 shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)
Detailed Description
Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester 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, Warfarin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin group
Arm Type
Active Comparator
Arm Description
Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy
Arm Title
Warfarin group
Arm Type
Active Comparator
Arm Description
Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Clexan
Intervention Description
Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Marevan
Intervention Description
Women will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy
Primary Outcome Measure Information:
Title
Fetal loss
Description
Unexplained fetal death of morphologically normal fetus after the first trimester
Time Frame
From 12 weeks to 42 weeks gestational age
Secondary Outcome Measure Information:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed I Eid, Dr
Phone
+201225401274
Email
dr_moh_eid@yahoo.com
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
Abdelmageed F Mashaly, 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed I Eid, Dr
Phone
+201225401274
Email
dr_moh_eid@yahoo.com
Facility Name
Private practice settings
City
Mansourah
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32358837
Citation
Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
Results Reference
derived

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Use of Warfarin After the First Trimester in Pregnant Women With APS

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