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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02326051

Enrollment

100

Registered

2014-12-25

Start date

2014-12-31

Completion date

2017-05-31

Last updated

2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid Syndrome, Recurrent Miscarriage

Keywords

Antiphospholipid syndrome, APS, LMWH

Brief 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)

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

Interventions

DRUGEnoxaparin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 38 Years

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

Exclusion criteria

* Women with systemic lupus erythematosus (SLE) * Women with active thromboembolic disorders * Women with history of previous thromboembolic disorders

Design outcomes

Primary

Measure	Time frame	Description
Ongoing pregnancy rate	After 12 weeks gestational age	Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women

Secondary

Measure	Time frame	Description
Fetal loss	From 20 weeks to 42 weeks gestational age	Unexplained fetal death of morphologically normal fetus after the first trimester
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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026