The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression

February 26, 2023 updated by: Seoul National University Bundang Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonguido
      • Seongnam-si, Gyeonguido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Pregnant women who will do delivery.
  • Gestational week >= 30 week
  • Singleton

Exclusion Criteria:

  • History of depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Control group with participants who do not get magnesium sulfate administration.
Magnesium group
Intervention group with participants who get magnesium sulfate administration.
Drug: Magnesium sulfate
Magnesium sulfate will be administered following a protocol that obstetricians already use in our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 week after discharge
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)
6 week after discharge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 26, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 26, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2209-780-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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