The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience
NCT ID: NCT02454322
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2015-05-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Magnesium
Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Treated with Magnesium Sulfate
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
No interventions assigned to this group
Interventions
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Magnesium Sulfate
Standard of care Magnesium Sulfate given to women with a diagnosis of a hypertensive disorder of pregnancy.
Eligibility Criteria
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Inclusion Criteria
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
2. Prior receipt of magnesium during pregnancy
3. Intrauterine fetal demise or neonatal demise
4. Chronic hypertension
18 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Emily Miller
Assistant Professor in Obstetrics and Gynecology-Maternal Fetal Medicine and Psychiatry and Behavioral Sciences
Principal Investigators
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Emily S. Miller, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB #200388
Identifier Type: -
Identifier Source: org_study_id
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