The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience

NCT02454322 | Completed

• 1 other identifier: IRB #200388
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. Other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

• Frequency of Postpartum Depression

  The frequency of postpartum depression at 2 weeks and 6 weeks postpartum

  Up to 6 weeks

Secondary Outcomes (2)

• Cognitive Function (measured using the Salthouse Digit Comparison and Size Judgment Span tests)

  4 days

• Pain (Self-reported)

  6 weeks

Study Arms (2)

Magnesium

Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Treated with Magnesium Sulfate

Drug: Magnesium Sulfate

No Magnesium

Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Not Treated with Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

Standard of care Magnesium Sulfate given to women with a diagnosis of a hypertensive disorder of pregnancy.

Magnesium

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This project will include 300 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 34 weeks gestation, have a singleton pregnancy, and have been diagnosis with a hypertensive disorder of pregnancy (either gestational hypertension or preeclampsia).

You may qualify if:

• Pregnant or immediately postpartum women
• Age 18 and over
• Singleton gestation
• Diagnosis of hypertensive disorder of pregnancy
• Gestational age of at least 34 weeks
• English-speaking

You may not qualify if:

• Women not meeting the above criteria
• Prior receipt of magnesium during pregnancy
• Intrauterine fetal demise or neonatal demise
• Chronic hypertension

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid and peripheral serum

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

Study Officials

• Emily S. Miller, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Obstetrics and Gynecology-Maternal Fetal Medicine and Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

US (1)