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

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.

Study Overview

• Status: Completed
• Conditions: Depression, Postpartum
• Intervention / Treatment: Drug: Magnesium Sulfate

Detailed Description

This prospective observational study of women with hypertensive disorders of pregnancy (gestational hypertension or preeclampsia) seeks to evaluate a number of markers of maternal postpartum well-being, including maternal mood, breastfeeding, cognitive function, maternal-infant attachment, maternal perception of control, and postpartum pain between women who did and did not receive magnesium prophylaxis in the peripartum period.

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 diagnosed with a hypertensive disorder of pregnancy (either gestational hypertension or preeclampsia). Women will be exposed to magnesium for the indication of preeclampsia at the discretion of their obstetric provider.

Intrapartum baseline magnesium serum levels will be drawn for all women. For women who are receiving a magnesium infusion, serum magnesium levels will be repeated during the magnesium infusion (after receipt of the bolus infusion). For women who elect to receive neuraxial analgesia, CSF will be obtained and central magnesium levels drawn at the time of epidural placement.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review. Surveys will be administered to assess potential confounders of depression. A baseline self-reported depression survey, the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) will be administered followed by a structured clinical interview for diagnosis (SCID), the gold standard for psychiatric research diagnosis. Women will be contacted at two weeks and again at six weeks postpartum and the QIDS-SR will be administered. For women with positive screens, a phone-based MINI will be performed.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

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 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).

Description

Inclusion Criteria:

1. Pregnant or immediately postpartum women
2. Age 18 and over
3. Singleton gestation
4. Diagnosis of hypertensive disorder of pregnancy
5. Gestational age of at least 34 weeks
6. English-speaking

Exclusion Criteria:

1. Women not meeting the above criteria
2. Prior receipt of magnesium during pregnancy
3. Intrauterine fetal demise or neonatal demise
4. Chronic hypertension

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Magnesium; Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Treated with Magnesium Sulfate	Drug: Magnesium Sulfate; Standard of care Magnesium Sulfate given to women with a diagnosis of a hypertensive disorder of pregnancy.
No Magnesium; Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Not Treated with Magnesium Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Postpartum Depression	The frequency of postpartum depression at 2 weeks and 6 weeks postpartum	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Function (measured using the Salthouse Digit Comparison and Size Judgment Span tests)	Immediate postpartum cognitive function	4 days
Pain (Self-reported)	Self-reported pain postpartum	6 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Emily S. Miller, MD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 15, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: IRB #200388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED