The Clinical Features and Pregnancy Outcomes of CTD Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-45
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 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.
Participate voluntarily in this study, willing to use medication and follow-up according to treatment plan, and sign informed consent.
Disqualifiers
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.
Trial population
female with pregnance in accordance with the diagnostic criteria of connective tissue disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prednisone
Drug5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Hydroxychloroquine
Drug100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Aspirin
Drug100mg, 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.
low molecular weight heparin Enoxaparin
Drug40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: The Antiphospholipid syndrome (APS)4 interventions
Group B: Undifferentiated connective tissue disease (UCTD)4 interventions
Trial outcomes
Primary outcomes
1
Live birth rate
Percentage of all patients that lead to live birth after 28 weeks of gestation
Time frame
After 28 weeks of gestationSecondary outcomes
1
Early fetal loss
Spontaneous pregnancy loss within 10 weeks of gestation
Time frame
within 10 weeks of gestation2
Late fetal loss
Spontaneous pregnancy loss after 10 weeks of gestation
Time frame
after 10 weeks of gestation3
Stillbirth
Spontaneous pregnancy loss after 20 weeks of gestation
Time frame
after 20 weeks of gestation4
Preterm delivery
Live birth before 37 weeks of gestation
Time frame
between 28 and 37 weeks of gestationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov