Timing of Initiation of LMWH Administration in Pregnant Women With APS

Antiphospholipid Syndrome Clinical Trial

Official title:

Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326051
• Other study ID #: MIE2
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2014
• Last updated: November 27, 2017
• Start date: December 2014
• Est. completion date: May 2017

Study information

• Verified date: November 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• 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 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
• Enoxaparin
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

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		After 12 weeks gestational age up to birth
Other	Thromboembolic complications		After 12 weeks gestational age up to birth
Primary	Ongoing pregnancy rate	Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women	After 12 weeks gestational age
Secondary	Fetal loss	Unexplained fetal death of morphologically normal fetus after the first trimester	From 20 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		At birth