We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02454322
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression, Postpartum 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 Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience
Study Start Date : May 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Frequency of Postpartum Depression [ Time Frame: Up to 6 weeks ]
    The frequency of postpartum depression at 2 weeks and 6 weeks postpartum


Secondary Outcome Measures :
  1. Cognitive Function (measured using the Salthouse Digit Comparison and Size Judgment Span tests) [ Time Frame: 4 days ]
    Immediate postpartum cognitive function

  2. Pain (Self-reported) [ Time Frame: 6 weeks ]
    Self-reported pain postpartum


Biospecimen Retention:   Samples Without DNA
Cerebrospinal fluid and peripheral serum

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454322


Contacts
Contact: Emily S. Miller, MD, MPH 312-472-4685 emily-miller-1@northwestern.edu
Contact: Allie Sakowicz, BA 312-503-9336 allison.sakowicz@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Allie Sakowicz    312-503-9336    allison.sakowicz@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Emily S. Miller, MD, MPH Northwestern University
More Information

Responsible Party: Emily Miller, Assistant Professor in Obstetrics and Gynecology-Maternal Fetal Medicine and Psychiatry and Behavioral Sciences, Northwestern University
ClinicalTrials.gov Identifier: NCT02454322     History of Changes
Other Study ID Numbers: IRB #200388
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Anticonvulsants
Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents