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

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05751746
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression	Drug: Magnesium sulfate

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 108 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression
• Actual Study Start Date: Jan 30, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Feb 28, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. postpartum depression [6 week after discharge]

   depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points.

2. postpartum depression severity [6 week after discharge]

   depression severity using K-EPDS; mild (7~13 points), moderate (14~19 points), severe (20~30 points)

Secondary Outcome Measures

1. postpartum depression [2week after discharge]

   depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points.

2. postpartum depression severity [2 week after discharge]

   depression severity using K-EPDS; mild (7~13 points), moderate (14~19 points), severe (20~30 points)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women who will do delivery.

• Gestational week >= 30 week

• Singleton

Exclusion Criteria:

• History of depression

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonguido	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05751746
• Other Study ID Numbers: B-2209-780-302
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression, Postpartum; Depression; Depressive Disorder; Magnesium Sulfate

Study Results

No Results Posted as of Mar 2, 2023