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

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ClinicalTrials.gov Identifier: NCT02454322
Recruitment Status : Active, not recruiting
First Posted : May 27, 2015
Last Update Posted : March 25, 2019
Sponsor:
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 March 25, 2019
Study Start Date May 2015
Estimated Primary Completion Date November 2019   (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
Change History Complete list of historical versions of study NCT02454322 on ClinicalTrials.gov Archive Site
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 22, 2015)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date November 2019   (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
Removed Location Countries  
 
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
Responsible Party Emily Miller, Northwestern University
Study Sponsor Northwestern University
Collaborators Not Provided
Investigators
Principal Investigator: Emily S. Miller, MD, MPH Northwestern University
PRS Account Northwestern University
Verification Date March 2019