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

• ClinicalTrials.gov Identifier: NCT02454322
• Recruitment Status: Completed
• First Posted: May 27, 2015
• Last Update Posted: May 5, 2022
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Emily Miller, Northwestern University

Tracking Information

• First Submitted Date: May 15, 2015
• First Posted Date: May 27, 2015
• Last Update Posted Date: May 5, 2022
• Actual Study Start Date: May 2015
• Actual Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 22, 2015)

Frequency of Postpartum Depression [ Time Frame: Up to 6 weeks ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 22, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience
• Official Title: The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience
• 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.

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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Cerebrospinal fluid and peripheral serum

• 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).
• Condition: Depression, Postpartum

Intervention

Drug: Magnesium Sulfate

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

Study Groups/Cohorts

• Magnesium
  Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Treated with Magnesium Sulfate
  Intervention: Drug: Magnesium Sulfate
• No Magnesium
  Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Not Treated with Magnesium Sulfate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: May 22, 2015): 300
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2021
• Actual Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02454322
• Other Study ID Numbers: IRB #200388
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Emily Miller, Northwestern University
• Original Responsible Party: Same as current
• Current Study Sponsor: Northwestern University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Northwestern University
• Verification Date: May 2022