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Completed

NCT Number: NCT02326051

Timing of Initiation of LMWH Administration in Pregnant Women With APS

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)

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Key information

Conditions

Recurrent Miscarriage Abortion, Habitual Abortion, Spontaneous Antiphospholipid Syndrome Autoimmune Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Pregnancy Complications Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Obstetrics and Gynecology Department in Mansoura University Hospital, Al Mansurah, Dakahlia Governorate, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

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

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 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 outcomes

  1. Fetal loss

    Time frame: From 20 weeks to 42 weeks gestational age

    Unexplained fetal death of morphologically normal fetus after the first trimester

  2. Preterm delivery

    Time frame: 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

  3. Intrauterine growth restriction (IUGR)

    Time frame: At birth

    Birth weight less than the 10th percentile for gestational age

  4. Congenital fetal malformations

    Time frame: At birth

Other outcomes

  1. Hemorrhagic complications

    Time frame: After 12 weeks gestational age up to birth

  2. Thromboembolic complications

    Time frame: After 12 weeks gestational age up to birth

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Abdelhafez

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 25, 2014
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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