The Clinical Features and Pregnancy Outcomes of CTD Patients
Recruiting
Observational Study
Connective Tissue DiseasesPregnancy Related
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 45
Sex
Female
Study type
Observational
Participants needed
126 (estimated)
Sponsor
Qilu Hospital of Shandong University · Other
Who this trial is looking for
This trial is looking for women aged 20-45 who have specific autoimmune diseases related to pregnancy. Participants will be monitored during their pregnancy and postpartum period while using prescribed medications.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged between 20 and 45 years old.
I have been diagnosed with antiphospholipid syndrome.
I have been diagnosed with undifferentiated connective tissue disease.
I have at least one symptom suggesting a connective tissue disease.
I am willing to participate voluntarily in this study.
I agree to use medication and follow the treatment plan.
I will sign informed consent.
You may not be able to join if
I have a known reason for previous pregnancy loss.
I have any severe heart, liver, kidney, blood, or hormonal disease.
I have an active infection.
I am allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin, or aspirin.
I have a history of digestive ulcers or upper gastrointestinal bleeding.
I have been diagnosed with systemic lupus erythematosus.
I disagree or cannot complete my pregnancy and follow-up after delivery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 curren…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.