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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0008483
Enrollment
500
Registered
2023-06-01
Start date
2023-03-29
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactYOON HEE CHOI

The Catholic University of Korea, Seoul St. Mary's Hospital

choiyh@catholic.ac.kr+82-2-3147-9275

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026