The Clinical Features and Pregnancy Outcomes of CTD Patients

Pregnancy Related Clinical Trial

Official title:

The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918524
• Other study ID #: CTD with Pregnancy QiluH
• Status: Recruiting
• Start date: September 11, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Qilu Hospital of Shandong University
• Contact: Qiang Shu, Dr.
• Phone: 0086-0531-82169654
• Email: shuqiang[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Pregnancy Related

Intervention

Drug:
• Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
• Hydroxychloroquine
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
• 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.
• 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.

Locations

Country	Name	City	State
China	Qilu Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Percentage of all patients that lead to live birth after 28 weeks of gestation	After 28 weeks of gestation
Secondary	Early fetal loss	Spontaneous pregnancy loss within 10 weeks of gestation	within 10 weeks of gestation
Secondary	Late fetal loss	Spontaneous pregnancy loss after 10 weeks of gestation	after 10 weeks of gestation
Secondary	Stillbirth	Spontaneous pregnancy loss after 20 weeks of gestation	after 20 weeks of gestation
Secondary	Preterm delivery	Live birth before 37 weeks of gestation	between 28 and 37 weeks of gestation
Secondary	Low-weight birth	newborns with low weight (<2500g)	after 28 weeks of gestation
Secondary	Premature rupture of membranes	the number of participants complicated with premature rupture of membranes	after 28 weeks of gestation
Secondary	Placental abruption	the number of participants complicated with placental abruption	after 28 weeks of gestation
Secondary	Fetal growth retardation (FGR)	weight below the 10th percentile for the gestational age	after 12 weeks of gestation
Secondary	Number of participants with low amniotic fluid during pregnancy	the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy	after 12 weeks of gestation
Secondary	Number of participants with abnormal S / D values during pregnancy	the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy	after 12 weeks of gestation
Secondary	Number of participants with placental hematoma during pregnancy	the number of participants whose B-ultrasound indicates placental hematoma during pregnancy	during pregnancy, an average of 10 months
Secondary	Eclampsia	New-onset hypertension after 20 weeks of gestation, with or without proteinuria > 300mg/24h, with or without any organ damage with seizures	after 20 weeks of gestation
Secondary	Gestational diabetes	the number of participants who were diagnosed with gestational diabetes	through study completion, an average of 10 months
Secondary	Gestational hypertension	the number of participants who were diagnosed with gestational hypertension	through study completion, an average of 10 months
Secondary	Number of participants with placental infarction	the number of participants whose placenta with infarction.	at delivery