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.
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 Type
OBSERVATIONAL
Enrollment
126
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
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.
40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.
Qilu Hospital
Jinan, Shandong, China
RECRUITINGLive birth rate
Percentage of all patients that lead to live birth after 28 weeks of gestation
Time frame: After 28 weeks of gestation
Early fetal loss
Spontaneous pregnancy loss within 10 weeks of gestation
Time frame: within 10 weeks of gestation
Late fetal loss
Spontaneous pregnancy loss after 10 weeks of gestation
Time frame: after 10 weeks of gestation
Stillbirth
Spontaneous pregnancy loss after 20 weeks of gestation
Time frame: after 20 weeks of gestation
Preterm delivery
Live birth before 37 weeks of gestation
Time frame: between 28 and 37 weeks of gestation
Low-weight birth
newborns with low weight (\<2500g)
Time frame: after 28 weeks of gestation
Premature rupture of membranes
the number of participants complicated with premature rupture of membranes
Time frame: after 28 weeks of gestation
Placental abruption
the number of participants complicated with placental abruption
Time frame: after 28 weeks of gestation
Fetal growth retardation (FGR)
weight below the 10th percentile for the gestational age
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after 20 weeks of gestation
Gestational diabetes
the number of participants who were diagnosed with gestational diabetes
Time frame: through study completion, an average of 10 months
Gestational hypertension
the number of participants who were diagnosed with gestational hypertension
Time frame: through study completion, an average of 10 months
Number of participants with placental infarction
the number of participants whose placenta with infarction.
Time frame: at delivery
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