Clinical trial NCT04918524: The Clinical Features and Pregnancy Outcomes of CTD Patients
Official title: The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Connective Tissue Diseases
Pregnancy Related
Keywords: Connective tissue disease
Pregnancy outcomes
Clinical features
Risk factors
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 126
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female with pregnance in accordance with the diagnostic criteria of connective tissue disease

Brief summary: Connective tissue disease (CTD) is a common group of autoimmune diseases, mainly including systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS) , and so on. APS is caused by autoimmune disorders that cause recurrent miscarriage, thrombosis, and thrombocytopenia, and often secondary to connective tissue diseases such as SLE. Undifferentiated connective tissue disease (UCTD) is currently considered to be an independent disease in the classification of CTD. And women of childbearing age who suffer UCTD is more common than that in other definite CTDs. Therefore, the impact of the disease flare and the influence of medicine on pregnancy and lactation are important for these patients who may suffer high-risk of abnormal pregnance.

Detailed description: Objective: To study the risk factors of poor pregnancy outcomes in CTD 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 CTD 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.

Eligibility criteria: Inclusion Criteria:

* Women who meet the following inclusion criteria will be eligible to participate in the study:

  1. Age between 20-45 years;
  2. Diagnosed with APS: patients meet the Sydney classification criteria;
  3. Diagnosed with UCTD: at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-extractable nuclear antigen (ENA) antibodies, anti-doublestranded DNA (ds-DNA) antibody, antiphospholipid antibody(aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting connective tissue disease(CTD) , while not fulfilling any classification criteria of a defined CTD.
  4. Participate voluntarily in this study, willing to use medication and follow-up according to treatment plan, and sign informed consent.

Exclusion Criteria:

* Women who meet any of the following criteria will be excluded from the study:

  1.Any known etiology of previous pregnancy loss:
  1. Known paternal, maternal or embryo chromosome abnormality.
  2. Maternal endocrine dysfunction: corpus luteal insufficiency; polycystic ovarian syndrome; premature ovarian failure (follicle stimulating hormone, FSH ≥20uU/L in follicular phase);
  3. hyperprolactinemia; diabetes mellitus; other hypothalamic pituitary-adrenal axis abnormality
  4. Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.Vaginal infection.
  5. Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:

  2. Any active infection: Active infection including V aricella zostervirus(VZV), human immunodeficiency virus (HIV), Human papillomavirus (HPV),syphilis or tuberculosis.

  3. Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.

  4.Disease history as follows:
  1. Past history of digestive ulcers or upper gastrointestinal hemorrhage.
  2. Past history of malignancy.
  3. Past history of epilepsia or psychotic disorders.

  5.Women have been diagnosed with Systemic lupus erythematosus

  6. Women who disagree or cannot complete pregnancy and follow-up after delivery.

Primary outcomes:
measure: Live birth rate
timeFrame: After 28 weeks of gestation
Secondary outcomes:
measure: Early fetal loss
timeFrame: within 10 weeks of gestation
measure: Late fetal loss
timeFrame: after 10 weeks of gestation
measure: Stillbirth
timeFrame: after 20 weeks of gestation
measure: Preterm delivery
timeFrame: between 28 and 37 weeks of gestation
measure: Low-weight birth
timeFrame: after 28 weeks of gestation
measure: Premature rupture of membranes
timeFrame: after 28 weeks of gestation
measure: Placental abruption
timeFrame: after 28 weeks of gestation
measure: Fetal growth retardation (FGR)
timeFrame: after 12 weeks of gestation
measure: Number of participants with low amniotic fluid during pregnancy
timeFrame: after 12 weeks of gestation
measure: Number of participants with abnormal S / D values during pregnancy
timeFrame: after 12 weeks of gestation
measure: Number of participants with placental hematoma during pregnancy
timeFrame: during pregnancy, an average of 10 months
measure: Eclampsia
timeFrame: after 20 weeks of gestation
measure: Gestational diabetes
timeFrame: through study completion, an average of 10 months
measure: Gestational hypertension
timeFrame: through study completion, an average of 10 months
measure: Number of participants with placental infarction
timeFrame: at delivery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiaoyun Yang, Dr.
role: STUDY_DIRECTOR
References: