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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05751746
Other study ID # B-2209-780-302
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2023
Est. completion date February 28, 2024

Study information

Verified date February 2023
Source Seoul National University Bundang Hospital
Contact Su Yeon Kim, Dr.
Phone +82-10-3325-2690
Email kittyrockz@nate.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is an observational study that will be conducted on pregnant women under vaginal delivery or cesarean section. The magnesium sulfate will be given to appropriate participants with a protocol that obstetrician are already using in our hospital. After delivery, participants are asked to answer sequential questionnaires to assess postpartum depression.


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date February 28, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant women who will do delivery. - Gestational week >= 30 week - Singleton Exclusion Criteria: - History of depression

Study Design


Intervention

Drug:
Magnesium sulfate
Magnesium sulfate will be administered following a protocol that obstetricians already use in our hospital.

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonguido

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary postpartum depression depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points. 6 week after discharge
Primary postpartum depression severity depression severity using K-EPDS; mild (7~13 points), moderate (14~19 points), severe (20~30 points) 6 week after discharge
Secondary postpartum depression depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points. 2week after discharge
Secondary postpartum depression severity depression severity using K-EPDS; mild (7~13 points), moderate (14~19 points), severe (20~30 points) 2 week after discharge
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