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

Sponsor

Mohamed Sayed Abdelhafez (Other)

Overall Status

Unknown status

CT.gov ID

NCT02303171

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Recurrent Miscarriage Antiphospholipid Syndrome	Drug: Enoxaparin Drug: Warfarin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Enoxaparin group Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy	Drug: Enoxaparin Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC) Other Names: Clexan
Active Comparator: Warfarin group Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester	Drug: Warfarin 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 Other Names: Marevan

Arm

Intervention/Treatment

Active Comparator: Enoxaparin group

Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy

Drug: Enoxaparin

Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)

Other Names:

Clexan

Active Comparator: Warfarin group

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

Drug: Warfarin

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

Other Names:

Marevan

Outcome Measures

Primary Outcome Measures

Fetal loss [From 12 weeks to 42 weeks gestational age]
Unexplained fetal death of morphologically normal fetus after the first trimester

Secondary Outcome Measures

Preterm delivery [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) [At birth]
Birth weight less than the 10th percentile for gestational age
Congenital fetal malformations [At birth]

Other Outcome Measures

Hemorrhagic complications [After 12 weeks gestational age up to birth]
Thromboembolic complications [After 12 weeks gestational age up to birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts 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