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NCT Number: NCT04976465

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Systemic lupus erythematosus (SLE) is a kind of systemic autoimmune disease which can cause multiple organs and system damage, which often occurs in women of childbearing age. Compared with healthy pregnant women, SLE patients have higher incidence of premature delivery, preeclampsia and fetal loss during pregnancy. Since SLE patients usually have disease activity during pregnancy and postpartum, and a variety of maternal and fetal diseases are closely related to SLE, it is very important to monitor the disease activity and drug treatment of SLE patients during pregnancy.

Recruiting

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

About this study

Objective: To study the risk factors of poor pregnancy outcomes in SLE patients, and evaluate impact of different therapies on the maternal and fetal health. Methods: Our department and Shanghai Gothic Network Technology Co., Ltd. jointly established the chronic disease management of SLE patients during pregnancy and lactation by using Smart System of Disease Management#SSDM#. With this platform#patients in pregnancy can consult with rheumatologists face to face and follow-up regularly.

Follow-up: Consultation and followup will be scheduled every 4 weeks from confirmed pregnancy until delivery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with systemic lupus erythematosus (SLE) (ACR criteria, 1997);
  • Pregnant women aged 20-45 years old;
  • Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.

Exclusion criteria

  • The cause of previous abortion was known:
  • Known chromosomal abnormalities in the parent, maternal or embryo.
  • Page 3 of 4 [DRAFT] -• Endocrine dysfunction of pregnant women: luteal dysfunction; Polycystic ovarian syndrome; Ovarian premature failure (FSH

≥ 20uu/ L) in follicular stage;

  • Hyperprolactinemia thyroid disease; Other hypothalamic pituitary adrenal axis abnormalities in diabetes mellitus.
  • Abnormal anatomy of pregnant women: abnormal uterus; Asherman syndrome; The uterine fibrosis of cervical insufficiency is more than 5 cm. Vaginal infection.
  • Any known serious heart disease, liver, kidney, blood or endocrine disease.
  • Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis.
  • Allergic to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin.
  • The history of the disease is as follows:
  • There was a history of peptic ulcer or upper gastrointestinal bleeding in the past.
  • The past history of malignant tumor.
  • The past history of epilepsy or psychosis.
  • Women who disagree or cannot complete the follow-up during pregnancy and after delivery.

Treatment and study plan

anticoagulation

Drug

Drug:

  • Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
  • Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.

Other Names: HCQ

  • Aspirin 100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response to 32 weeks of pregnancy. 75mg po, once per day (Qd) to 34 weeks of pregnancy. 50mg po, once per day (Qd) to 36 weeks of pregnancy.

Other Names: Asp

  • Low molecular weight heparin Enoxaparin 40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.

Other Names: LMWH

Without Anticoagulation

Drug

Drug:

  • Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
  • Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.

Other Names: HCQ

Primary outcomes

  1. Live birth rate

    Time frame: After 28 weeks of gestation]

    Percentage of all patients that lead to live birth after 28 weeks of gestation

Secondary outcomes

  1. Early miscarriage

    Time frame: within 10 weeks of gestation]

    Spontaneous pregnancy loss within 10 weeks of gestation

  2. Intrauterine deaths

    Time frame: after 10 weeks of gestation

    Spontaneous pregnancy loss after 10 weeks of gestation

  3. Stillbirth

    Time frame: after 20 weeks of gestation

    Spontaneous pregnancy loss after 20 weeks of gestation

  4. Intrauterine growth retardation (IUGR)

    Time frame: between 28 and 37 weeks of gestation

    weight below the 10th percentile for the gestational age

  5. Number of participants with low amniotic fluid during pregnancy

    Time frame: during pregnancy#an average of 10 months

    the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy

  6. Number of participants with abnormal S / D values during pregnancy

    Time frame: during pregnancy#an average of 10 months

    the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Shu, Dr.

CONTACT

[email protected]

0086-0531-82169654

Yunfei Guo, Bachelor

CONTACT

[email protected]

0086-0531-82169654

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2021
Registry last updated
Nov 18, 2023

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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