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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02303171
Other study ID # MIE1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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