Undifferentiated Connective Tissue DiseaseNCT03671174
Immunosuppressant Regimens for Living Fetuses Study
A study testing Prednisone, Hydroxychloroquine and Aspirin in people with Undifferentiated Connective Tissue Disease and Recurrent Pregnancy Loss, run by RenJi Hospital at 1 site in China.
Trial summary
Undifferentiated connective tissue diseases (UCTD) are known to increase the risk of pregnancy morbidities, including recurrent pregnancy loss. However, there is no consensus or guideline about the treatment for recurrent pregnancy loss in UCTD patients. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Undifferentiated Connective Tissue Disease, Recurrent Pregnancy Loss
- What is being tested?
- Prednisone, Hydroxychloroquine and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2019to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who meet the following inclusion criteria will be eligible to participate in the study:
- At reproductive age (20-40 years old).
- Trying to conceive.
- Diagnosed with UCTD[2]: at least one symptoms or signs suggesting connective tissue disease(CTD) and with at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-SSA antibody, while not fulfilling any classification criteria of a defined CTD.
- Diagnosed with RSA[39]: two or more failed pregnancies of unknown origin.
- Providing written informed consent. Exclusion criteria
Show all 23Show fewer
- Women who meet any of the following criteria will be excluded from the study:
- 1.Any known etiology of previous pregnancy loss:
- Diagnosis of antiphospholipid antibody syndrome.
- 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; thyroid disease; 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. 2.Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:
- (1)Alanine transaminase (ALT) or aspartate transaminase(AST) more than twice the upper limit of normal.
- (2)Clearance of creatinine less than 30mL/min. (3)Leucocytes less than 2.510^9/L, or Hemoglobine less than 85g/L, or Platelet less than 50~10^9/L.
- 3.Any active infection:
- Active viral hepatitis including hepatitis B virus (HBV), hepatitis C virus (HCV).
- Active infection including V aricella-zostervirus(VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis.
- 4.Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.
- 5.Disease history as follows:
- Past history of digestive ulcers or upper gastrointestinal hemorrhage.
- Past history of malignancy.
- Past history of epilepsia or psychotic disorders. 6.Woman unable to consent or impossible to follow-up.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200001
Liangjing Lu, +8613661472001, lu_liangjing@163.com
Shaoying Yang, +8613601984013, shaoying_yang@163.com
About this study
Official title: A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases: Protocol for the Immunosuppressant Regimens for Living FEtuses (ILIFE) Trial
Undifferentiated connective tissue diseases (UCTD) are known to increase the risk of pregnancy morbidities, including recurrent pregnancy loss. However, there is no consensus or guideline about the treatment for recurrent pregnancy loss in UCTD patients. Therefore, based on the tendency to thrombosis formation and placental inflammation in the pathogenesis of UCTD, this trial proposes to evaluate the effect of hydroxychloroquine with or without prednisone combined with anticoagulation on pregnancy outcomes in recurrent pregnancy loss patients with UCTD.
Read the detailed description
Objective: To evaluate the effect of anticoagulation with or without immunomodulatory therapy on pregnancy outcomes of recurrent pregnancy loss with undifferentiated connective tissue diseases Design: a multi-center, randomised, open-label, paralleled study. Patients: Pregnant patients with recurrent pregnancy loss and undifferentiated connective tissue diseases without any known etiology for pregnancy loss (detailed in section 10).
Methods: 420 selected patients are divided into 3 parallel groups (detailed in section 8).
Randomization: Patients who present to relevant clinics for management of recurrent spontaneous abortion (RSA) will be evaluated for inclusion criteria and exclusion criteria by a formed physician. Once patient is eligible for the study, the co-investigator will obtain written patient's consent. Participants will be randomized into one of the 3 groups. Randomized numbers will be generated by pharmacology research personnel in Renji Hospital. Given the different administrated medications, neither the patient nor the provider will be blinded.
Follow-up: Consultation will be scheduled every 4 weeks from confirmed pregnancy until delivery. The co-investigator will complete a follow-up survey including clinical, biological data.
Missing data: Patients are willing to drop the study, unavailable, incompliant, with severe complications or with severe adverse effects. The missing data will be recorded in detail and be analysed with last pregnancy outcome.
- Being tested
- Prednisone, Hydroxychloroquine, Aspirin, low molecular weight heparin
- Medical subject headings
- Undifferentiated Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
10mg once daily orally
100mg to 200mg twice daily orally
AspirinDrug
50mg once daily orally
low molecular weight heparinDrug
Also called Enoxaparin, Dalteparin, Nadroparin
Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Prednisone + hydroxychloroquine + anticoagulation | Experimental | Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Receives: Drug: Prednisone; Drug: Hydroxychloroquine; Drug: Aspirin; Drug: low molecular weight heparin |
| Hydroxychloroquine + anticoagulation | Experimental | Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Receives: Drug: Hydroxychloroquine; Drug: Aspirin; Drug: low molecular weight heparin |
| Anticoagulation | Active comparator | Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Receives: Drug: Aspirin; Drug: low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Percentage of all cycles that lead to live birth
Measured: After 28 weeks of gestation
Secondary outcomes (18)
Rate of miscarriage
Spontaneous pregnancy loss within 28 weeks of gestation, confirmed by pelvic ultrasound findings. This includes no yolk sac or embryo in a gestational sac and an embryo without cardiac activity.
Measured: Within 28 weeks of gestation
Premature birth
live birth between 28 and 37 weeks of gestations Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria > 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Measured: between 28 and 37 weeks of gestations
Intrauterine growth retardation
weight below the 10th percentile for the gestational age Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria > 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Measured: between 28 and 37 weeks of gestations
Gestational age and weight at birth
the children's gestational age and weight at birth
Measured: post-partum 6 weeks
Survival at 28 days
still alive at 28 days
Measured: post-partum 6 weeks
Number of newborns with treatment-related adverse events assessed by 3 parameters
assess the number of the newborns with abnormal vision, hearing and length at 6 weeks
Measured: post-partum 6 weeks
Congenital abnormality
congenital heart conduction block, neonatal lupus or malformation
Measured: post-partum 6 weeks
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
Number of participants with Infection
Infection of respiratory tract, digestive tract, urinary tract and skin
Measured: through study completion, an average of 1.5 years
Gestational diabetes mellitus
Clinical diagnosis of gestational diabetes mellitus
Measured: through study completion, an average of 1.5 years
Activity of UCTD
New onset or aggravation of symptoms like arthritis, rash, Reynolds phenomenon, proteinuria, etc.
Measured: through study completion, an average of 1.5 years
Number of participants who evolved to systemic lupus erythematosus(SLE) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of systemic lupus erythematosus
Measured: post-partum 6 weeks
Number of participants who evolved to Sjogren's syndrome(SS) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of Sjogren's syndrome
Measured: post-partum 6 weeks
Number of participants who evolved to systemic sclerosis(SSc) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of systemic sclerosis
Measured: post-partum 6 weeks
Number of participants who evolved to polymyositis(PM) or dermatomyositis(DM) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of polymyositis or dermatomyositis
Measured: post-partum 6 weeks
Number of participants who evolved to antiphospholipid syndrome (APS) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of antiphospholipid syndrome
Measured: post-partum 6 weeks
Number of participants who evolved to rheumatoid arthritis (RA) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of rheumatoid arthritis
Measured: post-partum 6 weeks
Number of participants who evolved to mixed connective tissue disease(MCTD) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of mixed connective tissue disease
Measured: post-partum 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start2 Aug 2019
- Primary completionSep 2021 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Undifferentiated Connective Tissue DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, China-Japan Union Hospital, Jilin University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Liangjing Lu, RenJi Hospital
- Investigators
- Liangjing Lu, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671174
- Sponsor's protocol ID
- ILIFE Study
- Status last verified
- Aug 2019
- First submitted
- 30 Aug 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mosca M, Neri R, Bombardieri S. Undifferentiated connective tissue diseases (UCTD): a review of the literature and a proposal for preliminary classification criteria. Clin Exp Rheumatol. 1999 Sep-Oct;17(5):615-20.
PubMed 10544849Andreoli L, Bertsias GK, Agmon-Levin N, Brown S, Cervera R, Costedoat-Chalumeau N, Doria A, Fischer-Betz R, Forger F, Moraes-Fontes MF, Khamashta M, King J, Lojacono A, Marchiori F, Meroni PL, Mosca M, Motta M, Ostensen M, Pamfil C, Raio L, Schneider M, Svenungsson E, Tektonidou M, Yavuz S, Boumpas D, Tincani A. EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 2017 Mar;76(3):476-485. doi: 10.1136/annrheumdis-2016-209770. Epub 2016 Jul 25.
PubMed 27457513Spinillo A, Beneventi F, Caporali R, Ramoni V, Montecucco C. Undifferentiated connective tissue diseases and adverse pregnancy outcomes. An undervalued association? Am J Reprod Immunol. 2017 Dec;78(6). doi: 10.1111/aji.12762. Epub 2017 Sep 16.
PubMed 28921728Alarcon GS, Williams GV, Singer JZ, Steen VD, Clegg DO, Paulus HE, Billingsley LM, Luggen ME, Polisson RP, Willkens RF, et al. Early undifferentiated connective tissue disease. I. Early clinical manifestation in a large cohort of patients with undifferentiated connective tissue diseases compared with cohorts of well established connective tissue disease. J Rheumatol. 1991 Sep;18(9):1332-9.
PubMed 1757934Laczik R, Soltesz P, Szodoray P, Szekanecz Z, Kerekes G, Paragh G, Rajnavolgyi E, Abel G, Szegedi G, Bodolay E. Impaired endothelial function in patients with undifferentiated connective tissue disease: a follow-up study. Rheumatology (Oxford). 2014 Nov;53(11):2035-43. doi: 10.1093/rheumatology/keu236. Epub 2014 Jun 10.
PubMed 24917564Spinillo A, Beneventi F, Locatelli E, Ramoni V, Caporali R, Alpini C, Albonico G, Cavagnoli C, Montecucco C. The impact of unrecognized autoimmune rheumatic diseases on the incidence of preeclampsia and fetal growth restriction: a longitudinal cohort study. BMC Pregnancy Childbirth. 2016 Oct 18;16(1):313. doi: 10.1186/s12884-016-1076-8.
PubMed 27756248Mosca M, Neri R, Strigini F, Carmignani A, Totti D, Tavoni A, Bombardieri S. Pregnancy outcome in patients with undifferentiated connective tissue disease: a preliminary study on 25 pregnancies. Lupus. 2002;11(5):304-7. doi: 10.1191/0961203302lu187oa.
PubMed 12090565Spinillo A, Beneventi F, Epis OM, Montanari L, Mammoliti D, Ramoni V, Di Silverio E, Alpini C, Caporali R, Montecucco C. The effect of newly diagnosed undifferentiated connective tissue disease on pregnancy outcome. Am J Obstet Gynecol. 2008 Dec;199(6):632.e1-6. doi: 10.1016/j.ajog.2008.05.008. Epub 2008 Jul 29.
PubMed 18667193Alijotas-Reig J, Ferrer-Oliveras R; EUROAPS Study Group. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): a preliminary first year report. Lupus. 2012 Jun;21(7):766-8. doi: 10.1177/0961203312440058.
PubMed 22635227Proietta M, Ferrero S, Ferri L, Cifani N, Bruno G, Del Porto F. Recurrent miscarriages in women not fulfilling classification criteria for antiphospholipid antibody syndrome. Int J Immunopathol Pharmacol. 2014 Jul-Sep;27(3):429-32. doi: 10.1177/039463201402700313.
PubMed 25280034Vaz CC, Couto M, Medeiros D, Miranda L, Costa J, Nero P, Barros R, Santos MJ, Sousa E, Barcelos A, Ines L. Undifferentiated connective tissue disease: a seven-center cross-sectional study of 184 patients. Clin Rheumatol. 2009 Aug;28(8):915-21. doi: 10.1007/s10067-009-1175-2. Epub 2009 Apr 24.
PubMed 19390908Bansal AS. Joining the immunological dots in recurrent miscarriage. Am J Reprod Immunol. 2010 Nov;64(5):307-15. doi: 10.1111/j.1600-0897.2010.00864.x.
PubMed 20528832Tempfer CB, Kurz C, Bentz EK, Unfried G, Walch K, Czizek U, Huber JC. A combination treatment of prednisone, aspirin, folate, and progesterone in women with idiopathic recurrent miscarriage: a matched-pair study. Fertil Steril. 2006 Jul;86(1):145-8. doi: 10.1016/j.fertnstert.2005.12.035. Epub 2006 May 23.
PubMed 16716321Gomaa MF, Elkholy AG, El-Said MM, Abdel-Salam NE. Combined oral prednisolone and heparin versus heparin: the effect on peripheral NK cells and clinical outcome in patients with unexplained recurrent miscarriage. A double-blind placebo randomized controlled trial. Arch Gynecol Obstet. 2014 Oct;290(4):757-62. doi: 10.1007/s00404-014-3262-0. Epub 2014 May 13.
PubMed 24818590Gonzalez-Lopez L, Gamez-Nava JI, Jhangri G, Russell AS, Suarez-Almazor ME. Decreased progression to rheumatoid arthritis or other connective tissue diseases in patients with palindromic rheumatism treated with antimalarials. J Rheumatol. 2000 Jan;27(1):41-6.
PubMed 10648016
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases: Protocol for the Immunosuppressant Regimens for Living FEtuses (ILIFE) Trial
- ClinicalTrials.gov ID
- NCT03671174
- Acronym / sponsor ID
- ILIFE Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, China-Japan Union Hospital, Jilin University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Xiangya Hospital of Central South University
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 14 Sep 2018 (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.
Undifferentiated connective tissue diseases (UCTD) are known to increase the risk of pregnancy morbidities, including recurrent pregnancy loss. However, there is no consensus or guideline about the treatment for recurrent pregnancy loss in UCTD patients. Therefore, based on the tendency to thrombosis formation and placental inflammation in the pathogenesis of UCTD, this trial proposes to evaluate the effect of hydroxychloroquine with or without prednisone combined with anticoagulation on pregnancy outcomes in recurrent pregnancy loss patients with UCTD.
Detailed description
Objective: To evaluate the effect of anticoagulation with or without immunomodulatory therapy on pregnancy outcomes of recurrent pregnancy loss with undifferentiated connective tissue diseases Design: a multi-center, randomised, open-label, paralleled study. Patients: Pregnant patients with recurrent pregnancy loss and undifferentiated connective tissue diseases without any known etiology for pregnancy loss (detailed in section 10).
Methods: 420 selected patients are divided into 3 parallel groups (detailed in section 8).
Randomization: Patients who present to relevant clinics for management of recurrent spontaneous abortion (RSA) will be evaluated for inclusion criteria and exclusion criteria by a formed physician. Once patient is eligible for the study, the co-investigator will obtain written patient's consent. Participants will be randomized into one of the 3 groups. Randomized numbers will be generated by pharmacology research personnel in Renji Hospital. Given the different administrated medications, neither the patient nor the provider will be blinded.
Follow-up: Consultation will be scheduled every 4 weeks from confirmed pregnancy until delivery. The co-investigator will complete a follow-up survey including clinical, biological data.
Missing data: Patients are willing to drop the study, unavailable, incompliant, with severe complications or with severe adverse effects. The missing data will be recorded in detail and be analysed with last pregnancy outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prednisone + hydroxychloroquine + anticoagulation | Experimental | Drug: Prednisone, Drug: Hydroxychloroquine, Drug: Aspirin, Drug: low molecular weight heparinOral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin |
| Hydroxychloroquine + anticoagulation | Experimental | Drug: Hydroxychloroquine, Drug: Aspirin, Drug: low molecular weight heparinOral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin |
| Anticoagulation | Active comparator | Drug: Aspirin, Drug: low molecular weight heparinOral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Women who meet the following inclusion criteria will be eligible to participate in the study:
- At reproductive age (20-40 years old).
- Trying to conceive.
- Diagnosed with UCTD[2]: at least one symptoms or signs suggesting connective tissue disease(CTD) and with at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-SSA antibody, while not fulfilling any classification criteria of a defined CTD.
- Diagnosed with RSA[39]: two or more failed pregnancies of unknown origin.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prednisone10mg once daily orally | Drug | Prednisone + hydroxychloroquine + anticoagulation |
| Hydroxychloroquine100mg to 200mg twice daily orally | Drug | Hydroxychloroquine + anticoagulation, Prednisone + hydroxychloroquine + anticoagulation |
| Aspirin50mg once daily orally | Drug | Anticoagulation, Hydroxychloroquine + anticoagulation, Prednisone + hydroxychloroquine + anticoagulation |
| low molecular weight heparinAlso: Enoxaparin, Dalteparin, NadroparinEnoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous | Drug | Anticoagulation, Hydroxychloroquine + anticoagulation, Prednisone + hydroxychloroquine + anticoagulation |
Primary outcome
Live birth rate
Time frame: After 28 weeks of gestation
Percentage of all cycles that lead to live birth
18 secondary outcomes
Rate of miscarriage
Time frame: Within 28 weeks of gestation
Premature birth
Time frame: between 28 and 37 weeks of gestations
Intrauterine growth retardation
Time frame: between 28 and 37 weeks of gestations
Gestational age and weight at birth
Time frame: post-partum 6 weeks
Survival at 28 days
Time frame: post-partum 6 weeks
Number of newborns with treatment-related adverse events assessed by 3 parameters
Time frame: post-partum 6 weeks
Congenital abnormality
Time frame: post-partum 6 weeks
Eclampsia
Time frame: After 20 weeks of gestation
Number of participants with Infection
Time frame: through study completion, an average of 1.5 years
Gestational diabetes mellitus
Time frame: through study completion, an average of 1.5 years
Activity of UCTD
Time frame: through study completion, an average of 1.5 years
Number of participants who evolved to systemic lupus erythematosus(SLE) from undifferentiated connective tissue diseases(UCTD)
Time frame: post-partum 6 weeks
Number of participants who evolved to Sjogren's syndrome(SS) from undifferentiated connective tissue diseases(UCTD)
Time frame: post-partum 6 weeks
Number of participants who evolved to systemic sclerosis(SSc) from undifferentiated connective tissue diseases(UCTD)
Time frame: post-partum 6 weeks
Number of participants who evolved to polymyositis(PM) or dermatomyositis(DM) from undifferentiated connective tissue diseases(UCTD)
Time frame: post-partum 6 weeks
Number of participants who evolved to antiphospholipid syndrome (APS) from undifferentiated connective tissue diseases(UCTD)
Time frame: post-partum 6 weeks
Number of participants who evolved to rheumatoid arthritis (RA) from undifferentiated connective tissue diseases(UCTD)
Time frame: post-partum 6 weeks
Number of participants who evolved to mixed connective tissue disease(MCTD) from undifferentiated connective tissue diseases(UCTD)
Time frame: post-partum 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Background: PubMed 10544849Mosca M, Neri R, Bombardieri S. Undifferentiated connective tissue diseases (UCTD): a review of the literature and a proposal for preliminary classification criteria. Clin Exp Rheumatol. 1999 Sep-Oct;17(5):615-20.
- Background: PubMed 27457513Andreoli L, Bertsias GK, Agmon-Levin N, Brown S, Cervera R, Costedoat-Chalumeau N, Doria A, Fischer-Betz R, Forger F, Moraes-Fontes MF, Khamashta M, King J, Lojacono A, Marchiori F, Meroni PL, Mosca M, Motta M, Ostensen M, Pamfil C, Raio L, Schneider M, Svenungsson E, Tektonidou M, Yavuz S, Boumpas D, Tincani A. EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 2017 Mar;76(3):476-485. doi: 10.1136/annrheumdis-2016-209770. Epub 2016 Jul 25.
- Background: PubMed 28921728Spinillo A, Beneventi F, Caporali R, Ramoni V, Montecucco C. Undifferentiated connective tissue diseases and adverse pregnancy outcomes. An undervalued association? Am J Reprod Immunol. 2017 Dec;78(6). doi: 10.1111/aji.12762. Epub 2017 Sep 16.
- Results publication: PubMed 1757934Alarcon GS, Williams GV, Singer JZ, Steen VD, Clegg DO, Paulus HE, Billingsley LM, Luggen ME, Polisson RP, Willkens RF, et al. Early undifferentiated connective tissue disease. I. Early clinical manifestation in a large cohort of patients with undifferentiated connective tissue diseases compared with cohorts of well established connective tissue disease. J Rheumatol. 1991 Sep;18(9):1332-9.
- Results publication: PubMed 24917564Laczik R, Soltesz P, Szodoray P, Szekanecz Z, Kerekes G, Paragh G, Rajnavolgyi E, Abel G, Szegedi G, Bodolay E. Impaired endothelial function in patients with undifferentiated connective tissue disease: a follow-up study. Rheumatology (Oxford). 2014 Nov;53(11):2035-43. doi: 10.1093/rheumatology/keu236. Epub 2014 Jun 10.
- Results publication: PubMed 27756248Spinillo A, Beneventi F, Locatelli E, Ramoni V, Caporali R, Alpini C, Albonico G, Cavagnoli C, Montecucco C. The impact of unrecognized autoimmune rheumatic diseases on the incidence of preeclampsia and fetal growth restriction: a longitudinal cohort study. BMC Pregnancy Childbirth. 2016 Oct 18;16(1):313. doi: 10.1186/s12884-016-1076-8.
- Results publication: PubMed 12090565Mosca M, Neri R, Strigini F, Carmignani A, Totti D, Tavoni A, Bombardieri S. Pregnancy outcome in patients with undifferentiated connective tissue disease: a preliminary study on 25 pregnancies. Lupus. 2002;11(5):304-7. doi: 10.1191/0961203302lu187oa.
- Results publication: PubMed 18667193Spinillo A, Beneventi F, Epis OM, Montanari L, Mammoliti D, Ramoni V, Di Silverio E, Alpini C, Caporali R, Montecucco C. The effect of newly diagnosed undifferentiated connective tissue disease on pregnancy outcome. Am J Obstet Gynecol. 2008 Dec;199(6):632.e1-6. doi: 10.1016/j.ajog.2008.05.008. Epub 2008 Jul 29.
- Results publication: PubMed 22635227Alijotas-Reig J, Ferrer-Oliveras R; EUROAPS Study Group. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): a preliminary first year report. Lupus. 2012 Jun;21(7):766-8. doi: 10.1177/0961203312440058.
- Results publication: PubMed 25280034Proietta M, Ferrero S, Ferri L, Cifani N, Bruno G, Del Porto F. Recurrent miscarriages in women not fulfilling classification criteria for antiphospholipid antibody syndrome. Int J Immunopathol Pharmacol. 2014 Jul-Sep;27(3):429-32. doi: 10.1177/039463201402700313.
- Results publication: PubMed 19390908Vaz CC, Couto M, Medeiros D, Miranda L, Costa J, Nero P, Barros R, Santos MJ, Sousa E, Barcelos A, Ines L. Undifferentiated connective tissue disease: a seven-center cross-sectional study of 184 patients. Clin Rheumatol. 2009 Aug;28(8):915-21. doi: 10.1007/s10067-009-1175-2. Epub 2009 Apr 24.
- Results publication: PubMed 20528832Bansal AS. Joining the immunological dots in recurrent miscarriage. Am J Reprod Immunol. 2010 Nov;64(5):307-15. doi: 10.1111/j.1600-0897.2010.00864.x.
- 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. This study is not recruiting at the moment.
Liangjing Lu study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone, Hydroxychloroquine and Aspirin in people with Undifferentiated Connective Tissue Disease and Recurrent Pregnancy Loss, run by RenJi Hospital 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 23 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangjing Lu (+86 13661472001, lu_liangjing@163.com), 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?
On the ClinicalTrials.gov record for NCT03671174, which also lists 21 linked publications.
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 12 Aug 2019.