The Clinical Features and Pregnancy Outcomes of CTD Patients

NCT04918524 | Recruiting

• 1 other identifier: CTD with Pregnancy QiluH
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Connective Tissue Diseases; Pregnancy Related

Keywords

Connective tissue disease; Pregnancy outcomes; Clinical features; Risk factors

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Percentage of all patients that lead to live birth after 28 weeks of gestation

  After 28 weeks of gestation

Secondary Outcomes (15)

• Early fetal loss

  within 10 weeks of gestation

• Late fetal loss

  after 10 weeks of gestation

• Stillbirth

  after 20 weeks of gestation

• Preterm delivery

  between 28 and 37 weeks of gestation

• Low-weight birth

  after 28 weeks of gestation

Study Arms (2)

The Antiphospholipid syndrome (APS)

The cohort includes that patients who meet the proposed Sydney criteria.

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.

Drug: Prednisone; Drug: Hydroxychloroquine; Drug: Aspirin; Drug: low molecular weight heparin Enoxaparin

Interventions

Prednisone DRUG

5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response

Also known as: Pred

The Antiphospholipid syndrome (APS); Undifferentiated connective tissue disease (UCTD)

Hydroxychloroquine DRUG

100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.

Also known as: HCQ

The Antiphospholipid syndrome (APS); Undifferentiated connective tissue disease (UCTD)

Aspirin DRUG

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.

Also known as: Asp

The Antiphospholipid syndrome (APS); Undifferentiated connective tissue disease (UCTD)

low molecular weight heparin Enoxaparin DRUG

40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.

Also known as: LMWH

The Antiphospholipid syndrome (APS); Undifferentiated connective tissue disease (UCTD)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

female with pregnance in accordance with the diagnostic criteria of connective tissue disease

You may qualify if:

• 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.

You may not qualify if:

• Women who meet any of the following criteria will be excluded from the study:
• 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.
• Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:
• \. Any active infection: Active infection including V aricella zostervirus(VZV), human immunodeficiency virus (HIV), Human papillomavirus (HPV),syphilis or tuberculosis.
• \. Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.
• Disease history as follows:
• Past history of digestive ulcers or upper gastrointestinal hemorrhage.
• Past history of malignancy.
• Past history of epilepsia or psychotic disorders.
• Women have been diagnosed with Systemic lupus erythematosus
• \. Women who disagree or cannot complete pregnancy and follow-up after delivery.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Connective Tissue Diseases

Interventions

Prednisone; prednylidene; Hydroxychloroquine; Aspirin; Agouti Signaling Protein; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Xiaoyun Yang, Dr.

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Qiang Shu, Dr.

CONTACT

0086-0531-82169654; shuqiang@sdu.edu.cn

Shuting Li

CONTACT

0086-0531-82169654; leeshuting1994@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 9, 2021
• Study Start: September 11, 2018
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)