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

Antiphospholipid Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02303171
• Other study ID #: MIE1
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: Mohamed I Eid, Dr
• Phone: +201225401274
• Email: dr_moh_eid[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Antiphospholipid Syndrome
• Recurrent Miscarriage
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah	Dakahlia
Egypt	Private practice settings	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemorrhagic complications	Hemorrhagic complications	After 12 weeks gestational age up to birth
Other	Thromboembolic complications	Thromboembolic complications	After 12 weeks gestational age up to birth
Primary	Fetal loss	Unexplained fetal death of morphologically normal fetus after the first trimester	From 12 weeks to 42 weeks gestational age
Secondary	Preterm delivery	Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency	From 20 weeks to 34 weeks gestational age
Secondary	Intrauterine growth restriction (IUGR)	Birth weight less than the 10th percentile for gestational age	At birth
Secondary	Congenital fetal malformations	Congenital fetal malformations	At birth