Timing of Initiation of LMWH Administration in Pregnant Women With APS

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

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)

Study Overview

• Status: Completed
• Conditions: Recurrent Miscarriage; Antiphospholipid Syndrome
• Intervention / Treatment: Drug: Enoxaparin; Drug: Enoxaparin

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35111
      • Obstetrics and Gynecology Department in Mansoura University Hospital
    • Mansourah, Dakahlia, Egypt
      • Private practice settings

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early Enoxaparin initiation; Women will start Enoxaparin therapy once positive pregnancy test is established	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; Other Names: Clexan; Drug: 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; Other Names: Clexan
Active Comparator: Later Enoxaparin initiation; Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation	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; Other Names: Clexan; Drug: 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; Other Names: Clexan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intrauterine growth restriction (IUGR)	Birth weight less than the 10th percentile for gestational age	At birth
Congenital fetal malformations		At birth
Fetal loss	Unexplained fetal death of morphologically normal fetus after the first trimester	From 20 weeks to 42 weeks gestational age

Other Outcome Measures

Outcome Measure	Time Frame
Hemorrhagic complications	After 12 weeks gestational age up to birth
Thromboembolic complications	After 12 weeks gestational age up to birth

Collaborators and Investigators

• Sponsor: Mohamed Sayed Abdelhafez
• Investigators: Principal Investigator: Mohamed I Eid, Dr, Mansoura University; Study Chair: Ahmed Badawy, Prof, Mansoura University; Study Director: Ahmed El-Zayadi, Dr, Mansoura University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Antiphospholipid syndrome; APS; LMWH
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Pregnancy Complications; Syndrome; Abortion, Spontaneous; Abortion, Habitual; Antiphospholipid Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: MIE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided