Systemic Lupus ErythematosusPhase 1NCT04976465
Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
A Phase 1 study testing Anticoagulation and Without Anticoagulation in people with Systemic Lupus Erythematosus and Pregnancy Related, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Systemic lupus erythematosus (SLE) is a kind of systemic autoimmune disease which can cause multiple organs and system damage, which often occurs in women of childbearing age. Compared with healthy pregnant women, SLE patients have higher incidence of premature delivery, preeclampsia and fetal loss during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Pregnancy Related
- What is being tested?
- Anticoagulation and Without Anticoagulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2026
- Phase
- Phase 1
- 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
Who may be able to join
- Patients diagnosed with systemic lupus erythematosus (SLE) (ACR criteria, 1997);
- Pregnant women aged 20-45 years old;
- Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
Who cannot join
- The cause of previous abortion was known:
- Known chromosomal abnormalities in the parent, maternal or embryo.
- Page 3 of 4 [DRAFT] -• Endocrine dysfunction of pregnant women: luteal dysfunction; Polycystic ovarian syndrome; Ovarian premature failure (FSH
- ≥ 20uu/ L) in follicular stage;
- Hyperprolactinemia thyroid disease; Other hypothalamic pituitary adrenal axis abnormalities in diabetes mellitus.
- Abnormal anatomy of pregnant women: abnormal uterus; Asherman syndrome; The uterine fibrosis of cervical insufficiency is more than 5 cm. Vaginal infection.
Show all 14Show fewer
- Any known serious heart disease, liver, kidney, blood or endocrine disease.
- Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis.
- Allergic to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin.
- The history of the disease is as follows:
- There was a history of peptic ulcer or upper gastrointestinal bleeding in the past.
- The past history of malignant tumor.
- The past history of epilepsy or psychosis.
- Women who disagree or cannot complete the follow-up during pregnancy and 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: Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
Systemic lupus erythematosus (SLE) is a kind of systemic autoimmune disease which can cause multiple organs and system damage, which often occurs in women of childbearing age. Compared with healthy pregnant women, SLE patients have higher incidence of premature delivery, preeclampsia and fetal loss during pregnancy. Since SLE patients usually have disease activity during pregnancy and postpartum, and a variety of maternal and fetal diseases are closely related to SLE, it is very important to monitor the disease activity and drug treatment of SLE patients during pregnancy.
Read the detailed description
Objective: To study the risk factors of poor pregnancy outcomes in SLE 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 SLE 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
- Systemic Lupus Erythematosus, Pregnancy Related
- Being tested
- Anticoagulation, Without Anticoagulation
- Keywords
- Systemic Lupus Erythematosus, Pregnancy Related, clinical features, Risk factors
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulationDrug
Drug:
- Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
- Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ
- 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: Asp
- 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: LMWH
Without AnticoagulationDrug
Drug:
- Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
- Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names: HCQ
| Study group | Role | What they receive |
|---|---|---|
| combined with aPL(+) | Experimental | the antiphospholipid antibodies appear in blood at least once Receives: Drug: Anticoagulation; Drug: Without Anticoagulation |
| combined with aPL(-) | Experimental | the antiphospholipid antibodies never appear in blood Receives: Drug: Anticoagulation; Drug: Without Anticoagulation |
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 (6)
Early miscarriage
Spontaneous pregnancy loss within 10 weeks of gestation
Measured: within 10 weeks of gestation]
Intrauterine deaths
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
Intrauterine growth retardation (IUGR)
weight below the 10th percentile for the gestational age
Measured: between 28 and 37 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: during pregnancy#an average of 10 months
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: during pregnancy#an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Jan 2018
- Primary completion30 Jul 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 Systemic Lupus ErythematosusStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT04976465
- Sponsor's protocol ID
- SLE with Pregnancy QiluH
- Status last verified
- Nov 2023
- First submitted
- 9 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
- ClinicalTrials.gov ID
- NCT04976465
- Acronym / sponsor ID
- SLE with Pregnancy QiluH
- Conditions
- Systemic Lupus Erythematosus, Pregnancy Related
- Keywords
- Systemic Lupus Erythematosus, Pregnancy Related, clinical features, Risk factors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jul 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.
Systemic lupus erythematosus (SLE) is a kind of systemic autoimmune disease which can cause multiple organs and system damage, which often occurs in women of childbearing age. Compared with healthy pregnant women, SLE patients have higher incidence of premature delivery, preeclampsia and fetal loss during pregnancy. Since SLE patients usually have disease activity during pregnancy and postpartum, and a variety of maternal and fetal diseases are closely related to SLE, it is very important to monitor the disease activity and drug treatment of SLE patients during pregnancy.
Detailed description
Objective: To study the risk factors of poor pregnancy outcomes in SLE 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 SLE 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined with aPL(+) | Experimental | Drug: Anticoagulation, Drug: Without Anticoagulationthe antiphospholipid antibodies appear in blood at least once |
| combined with aPL(-) | Experimental | Drug: Anticoagulation, Drug: Without Anticoagulationthe antiphospholipid antibodies never appear in blood |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with systemic lupus erythematosus (SLE) (ACR criteria, 1997);
- Pregnant women aged 20-45 years old;
- Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
Key exclusion criteria (14 listed)
- The cause of previous abortion was known:
- ≥ 20uu/ L) in follicular stage;
- Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis.
- Allergic to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin.
- The history of the disease is as follows:
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 |
|---|---|---|
| AnticoagulationDrug: 1. Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred 2. Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ 3. 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: Asp 4. 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: LMWH | Drug | combined with aPL(+), combined with aPL(-) |
| Without AnticoagulationDrug: 1. Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred 2. Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ | Drug | combined with aPL(+), combined with aPL(-) |
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
6 secondary outcomes
Early miscarriage
Time frame: within 10 weeks of gestation]
Intrauterine deaths
Time frame: after 10 weeks of gestation
Stillbirth
Time frame: after 20 weeks of gestation
Intrauterine growth retardation (IUGR)
Time frame: between 28 and 37 weeks of gestation
Number of participants with low amniotic fluid during pregnancy
Time frame: during pregnancy#an average of 10 months
Number of participants with abnormal S / D values during pregnancy
Time frame: during pregnancy#an average of 10 months
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.
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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?
A Phase 1 study testing Anticoagulation and Without Anticoagulation in people with Systemic Lupus Erythematosus 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 3 inclusion and 14 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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; AzTrials last refreshed its copy on 8 Nov 2026.