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

NCT05751746 | Unknown

• 1 other identifier: B-2209-780-302
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• postpartum depression

  2week after discharge

• postpartum depression severity

  2 week after discharge

Study Arms (2)

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

Interventions

Magnesium sulfate DRUG

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

Magnesium group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants are all pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• History of depression

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonguido, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Su Yeon Kim, Dr.

CONTACT

+82-10-3325-2690; kittyrockz@nate.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 2, 2023
• Study Start: January 30, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 28, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)