Postpartum DepressionNCT05751746
The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression
An observational study of Postpartum Depression, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Magnesium sulfate
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2023to 28 Feb 2024
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This is aimed adult singleton pregnant women with gestation age more than 30 weeks who are scheduled to give birth. Participants who get peripartum administration of magnesium sulfate are classified as magnesium group, and participants who do not get magnesium sulfate administration are classified as control group.
Who may be able to join
- Pregnant women who will do delivery.
- Gestational week >= 30 week
- Singleton
Who cannot join
- History of depression
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonguido, 13620
Su Yeon Kim, Dr., +82-10-3325-2690, kittyrockz@nate.com
About this study
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.
- Conditions
- Postpartum Depression
- Being tested
- Magnesium sulfate
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Magnesium sulfate will be administered following a protocol that obstetricians already use in our hospital.
| Study group | Role | What they receive |
|---|---|---|
| Control | Control group with participants who do not get magnesium sulfate administration. | |
| Magnesium group | Intervention group with participants who get magnesium sulfate administration. Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum depression
depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points.
Measured: 6 week after discharge
postpartum depression severity
depression severity using K-EPDS; mild (7~13 points), moderate (14~19 points), severe (20~30 points)
Measured: 6 week after discharge
Secondary outcomes (2)
postpartum depression
depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points.
Measured: 2week after discharge
postpartum depression severity
depression severity using K-EPDS; mild (7~13 points), moderate (14~19 points), severe (20~30 points)
Measured: 2 week after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start30 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751746
- Sponsor's protocol ID
- B-2209-780-302
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression
- ClinicalTrials.gov ID
- NCT05751746
- Acronym / sponsor ID
- B-2209-780-302
- Conditions
- Postpartum Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Control group with participants who do not get magnesium sulfate administration. |
| Magnesium group | – | Drug: Magnesium sulfateIntervention group with participants who get magnesium sulfate administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is aimed adult singleton pregnant women with gestation age more than 30 weeks who are scheduled to give birth. Participants who get peripartum administration of magnesium sulfate are classified as magnesium group, and participants who do not get magnesium sulfate administration are classified as control group.
Key inclusion criteria (3 listed)
- Pregnant women who will do delivery.
- Gestational week >= 30 week
- Singleton
Key exclusion criteria (1 listed)
- History of depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateMagnesium sulfate will be administered following a protocol that obstetricians already use in our hospital. | Drug | Magnesium group |
Primary outcome
postpartum depression
Time frame: 6 week after discharge
depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points.
postpartum depression severity
Time frame: 6 week after discharge
depression severity using K-EPDS; mild (7~13 points), moderate (14~19 points), severe (20~30 points)
2 secondary outcomes
postpartum depression
Time frame: 2week after discharge
postpartum depression severity
Time frame: 2 week after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Yeon Kim, Dr. (+82-10-3325-2690, kittyrockz@nate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postpartum depression (time frame: 6 week after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.