The Clinical Features and Pregnancy Outcomes of CTD Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| The Antiphospholipid syndrome (APS) The cohort includes that patients who meet the proposed Sydney criteria. |
Drug: Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Other Names:
Drug: Hydroxychloroquine
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names:
Drug: 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:
Drug: 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:
|
| Undifferentiated connective tissue disease (UCTD) The cohort includes the patients who are 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, aPL, and anti-cyclic citrullinated peptide (CCP) antibody, with or without at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD. |
Drug: Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Other Names:
Drug: Hydroxychloroquine
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names:
Drug: 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:
Drug: 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:
|
Outcome Measures
Primary Outcome Measures
- Live birth rate [After 28 weeks of gestation]
Percentage of all patients that lead to live birth after 28 weeks of gestation
Secondary Outcome Measures
- Early miscarriage [within 10 weeks of gestation]
Spontaneous pregnancy loss within 10 weeks of gestation
- Intrauterine deaths [after 10 weeks of gestation]
Spontaneous pregnancy loss after 10 weeks of gestation
- Stillbirth [after 20 weeks of gestation]
Spontaneous pregnancy loss after 20 weeks of gestation
- Intrauterine growth retardation (IUGR) [between 28 and 37 weeks of gestation]
weight below the 10th percentile for the gestational age
- Number of participants with low amniotic fluid during pregnancy [during pregnancy, an average of 10 months]
the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy
- Number of participants with abnormal S / D values during pregnancy [during pregnancy, an average of 10 months]
the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy
- Eclampsia [after 20 weeks of gestation]
New-onset hypertension after 20 weeks of gestation, with or without proteinuria > 300mg/24h, with or without any organ damage with seizures
- Number of participants with Infection [through study completion, an average of 10 months]
Infection of respiratory tract, digestive tract, urinary tract and skin.
- Number of newborn with neonatal complications [at birth]
the number of participants whose newborn diagnosed with respiratory distress, neonatal jaundice and so on.
- Number of participants with placental infarction [at delivery]
the number of participants whose placenta with infarction.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women who meet the following inclusion criteria will be eligible to participate in the study:
-
Age between 20-45 years;
-
Diagnosed with APS: patients meet the Sydney classification criteria;
-
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 anti-cyclic citrullinated peptide (CCP) antibody, with or without at least one symptoms or signs suggesting connective tissue disease(CTD) , while not fulfilling any classification criteria of a defined CTD.
-
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:
-
Known paternal, maternal or embryo chromosome abnormality.
-
Maternal endocrine dysfunction: corpus luteal insufficiency; polycystic ovarian syndrome; premature ovarian failure (follicle stimulating hormone, FSH ≥20uU/L in follicular phase);
-
hyperprolactinemia; diabetes mellitus; other hypothalamic pituitary-adrenal axis abnormality
-
Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.Vaginal infection.
-
Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:
-
Any active infection: Active infection including V aricella zostervirus(VZV), human immunodeficiency virus (HIV), Human papillomavirus (HPV),syphilis or tuberculosis.
-
Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.
4.Disease history as follows:
-
Past history of digestive ulcers or upper gastrointestinal hemorrhage.
-
Past history of malignancy.
-
Past history of epilepsia or psychotic disorders.
5.Women have been diagnosed with Systemic lupus erythematosus
- Women who disagree or cannot complete pregnancy and follow-up after delivery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
Investigators
- Study Director: Xiaoyun Yang, Dr., Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTD with Pregnancy QiluH