Connective Tissue DiseasesNCT04918524
The Clinical Features and Pregnancy Outcomes of CTD Patients
An observational study of Connective Tissue Diseases and Pregnancy Related, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Connective Tissue Diseases, Pregnancy Related
- What is being tested?
- Prednisone, Hydroxychloroquine and Aspirin
- Type of treatment
- Injection or infusion
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: female with pregnance in accordance with the diagnostic criteria of connective tissue disease
Who may be able to join
- 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 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.
Who cannot join
- 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.
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- 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:
- 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
- 6. Women who disagree or cannot complete pregnancy and follow-up after delivery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital
Jinan, Shandong, 250012
Xiaoyun Yang, Dr, 0086-0531-82169166, qlyykyc@163.com
About this study
Official title: The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Connective Tissue Diseases, Pregnancy Related
- Being tested
- Prednisone, Hydroxychloroquine, Aspirin, low molecular weight heparin Enoxaparin
- Keywords
- Connective tissue disease, Pregnancy outcomes, Clinical features, Risk factors
- Medical subject headings
- Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Pred
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Also called HCQ
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
AspirinDrug
Also called Asp
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.
low molecular weight heparin EnoxaparinDrug
Also called LMWH
40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.
| Study group | Role | What they receive |
|---|---|---|
| The Antiphospholipid syndrome (APS) | The cohort includes that patients who meet the proposed Sydney criteria. Receives: Drug: Prednisone; Drug: Hydroxychloroquine; Drug: Aspirin; Drug: low molecular weight heparin Enoxaparin | |
| 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, antiphospholipid antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD. Receives: Drug: Prednisone; Drug: Hydroxychloroquine; Drug: Aspirin; Drug: low molecular weight heparin Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Percentage of all patients that lead to live birth after 28 weeks of gestation
Measured: After 28 weeks of gestation
Secondary outcomes (15)
Early fetal loss
Spontaneous pregnancy loss within 10 weeks of gestation
Measured: within 10 weeks of gestation
Late fetal loss
Spontaneous pregnancy loss after 10 weeks of gestation
Measured: after 10 weeks of gestation
Stillbirth
Spontaneous pregnancy loss after 20 weeks of gestation
Measured: after 20 weeks of gestation
Preterm delivery
Live birth before 37 weeks of gestation
Measured: between 28 and 37 weeks of gestation
Low-weight birth
newborns with low weight (<2500g)
Measured: after 28 weeks of gestation
Premature rupture of membranes
the number of participants complicated with premature rupture of membranes
Measured: after 28 weeks of gestation
Placental abruption
the number of participants complicated with placental abruption
Measured: after 28 weeks of gestation
Fetal growth retardation (FGR)
weight below the 10th percentile for the gestational age
Measured: after 12 weeks of gestation
Number of participants with low amniotic fluid during pregnancy
the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy
Measured: after 12 weeks of gestation
Number of participants with abnormal S / D values during pregnancy
the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy
Measured: after 12 weeks of gestation
Number of participants with placental hematoma during pregnancy
the number of participants whose B-ultrasound indicates placental hematoma during pregnancy
Measured: during pregnancy, an average of 10 months
Eclampsia
New-onset hypertension after 20 weeks of gestation, with or without proteinuria > 300mg/24h, with or without any organ damage with seizures
Measured: after 20 weeks of gestation
Gestational diabetes
the number of participants who were diagnosed with gestational diabetes
Measured: through study completion, an average of 10 months
Gestational hypertension
the number of participants who were diagnosed with gestational hypertension
Measured: through study completion, an average of 10 months
Number of participants with placental infarction
the number of participants whose placenta with infarction.
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start11 Sep 2018
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Shu, Qilu Hospital of Shandong University
- Investigators
- Xiaoyun Yang, Dr., Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918524
- Sponsor's protocol ID
- CTD with Pregnancy QiluH
- Status last verified
- Nov 2023
- First submitted
- 2 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04918524
- Acronym / sponsor ID
- CTD with Pregnancy QiluH
- Conditions
- Connective Tissue Diseases, Pregnancy Related
- Keywords
- Connective tissue disease, Pregnancy outcomes, Clinical features, Risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Antiphospholipid syndrome (APS) | – | Drug: Prednisone, Drug: Hydroxychloroquine, Drug: Aspirin, Drug: low molecular weight heparin EnoxaparinThe cohort includes that patients who meet the proposed Sydney criteria. |
| Undifferentiated connective tissue disease (UCTD) | – | Drug: Prednisone, Drug: Hydroxychloroquine, Drug: Aspirin, Drug: low molecular weight heparin EnoxaparinThe 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, antiphospholipid antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female with pregnance in accordance with the diagnostic criteria of connective tissue disease
Key inclusion criteria (5 listed)
- Women who meet the following inclusion criteria will be eligible to participate in the study:
Key exclusion criteria (15 listed)
- Women who meet any of the following criteria will be excluded from the study:
- 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.
- 5.Women have been diagnosed with Systemic lupus erythematosus
- 6. Women who disagree or cannot complete pregnancy and follow-up after delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: Pred5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response | Drug | The Antiphospholipid syndrome (APS), Undifferentiated connective tissue disease (UCTD) |
| HydroxychloroquineAlso: HCQ100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. | Drug | The Antiphospholipid syndrome (APS), Undifferentiated connective tissue disease (UCTD) |
| AspirinAlso: Asp100mg, 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. | Drug | The Antiphospholipid syndrome (APS), Undifferentiated connective tissue disease (UCTD) |
| low molecular weight heparin EnoxaparinAlso: LMWH40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response. | Drug | The Antiphospholipid syndrome (APS), Undifferentiated connective tissue disease (UCTD) |
Primary outcome
Live birth rate
Time frame: After 28 weeks of gestation
Percentage of all patients that lead to live birth after 28 weeks of gestation
15 secondary outcomes
Early fetal loss
Time frame: within 10 weeks of gestation
Late fetal loss
Time frame: after 10 weeks of gestation
Stillbirth
Time frame: after 20 weeks of gestation
Preterm delivery
Time frame: between 28 and 37 weeks of gestation
Low-weight birth
Time frame: after 28 weeks of gestation
Premature rupture of membranes
Time frame: after 28 weeks of gestation
Placental abruption
Time frame: after 28 weeks of gestation
Fetal growth retardation (FGR)
Time frame: after 12 weeks of gestation
Number of participants with low amniotic fluid during pregnancy
Time frame: after 12 weeks of gestation
Number of participants with abnormal S / D values during pregnancy
Time frame: after 12 weeks of gestation
Number of participants with placental hematoma during pregnancy
Time frame: during pregnancy, an average of 10 months
Eclampsia
Time frame: after 20 weeks of gestation
Gestational diabetes
Time frame: through study completion, an average of 10 months
Gestational hypertension
Time frame: through study completion, an average of 10 months
Number of participants with placental infarction
Time frame: at delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyun Yang, Dr. study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Diseases and Pregnancy Related, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Shu, Dr. (0086-0531-82169654, shuqiang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: After 28 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.