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A prospective observational study to evaluate the effectiveness of digital management model on the pregnancy outcome in women with diabetes during pregnancy

Not Applicable
Recruiting
Conditions
Pregnancy, childbirth and the puerperium
Registration Number
KCT0008483
Lead Sponsor
The Catholic University of Korea, Seoul St. Mary's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
500
Inclusion Criteria

(main study)
1. pregnancy women with gestational diabetes or preexisting type 2 diabetes
2. age of 19 ~ 45 years
3. gestational age within 35week 6 days
4. person with informed consent

(sub-study)
1. pregnant women with diabetes or within 1 year from delivery
- subcohort 1 (Current GDM): pregnant women with GDM or type 2 DM
- subcohort 2 (Historical GDM): women with GDM during pregnancy who did not diagnosed with diabetes and within 1 year after delivery
2. age of 19 ~ 45 years
3. person with informed consent

Exclusion Criteria

(main study)
1. the person who cannot use smartphone applications
2. patients with type 1 diabetes mellitus
3. the person who is not eligible for this study at the clinician's discretion

(sub-study)
1. the person who cannot use smartphone applications
2. patients with type 1 diabetes mellitus

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
composite of adverse neonatal outcomes (birth weight >= 4000g, LGA >=90%ile , SGA =<10%ile, NICU admission, neonatal abnormality, Apgar score <7 points at 5 min, fetal/neonatal death, emergency C section, preterm delivery)
Secondary Outcome Measures
NameTimeMethod
neonatal outcome : birth weight >= 4000g;neonatal outcome : LGA >=90%ile;neonatal outcome :SGA =<10%ile;neonatal outcome : NICU admission;neonatal outcome : neonatal abnormality;neonatal outcome : Apgar score <7 points at 5 min;neonatal outcome : fetal/neonatal death;neonatal outcome : emergency C section;neonatal outcome : preterm delivery
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