The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience
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|ClinicalTrials.gov Identifier: NCT02454322|
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment|
|Depression, Postpartum||Drug: Magnesium Sulfate|
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|
|Estimated Enrollment :||300 participants|
|Official Title:||The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||May 2019|
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.
Hypertensive Disorder of Pregnancy (gestational hypertension or preeclampsia) Not Treated with Magnesium Sulfate
- Frequency of Postpartum Depression [ Time Frame: Up to 6 weeks ]The frequency of postpartum depression at 2 weeks and 6 weeks postpartum
- 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
Biospecimen Retention: Samples Without DNA
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
|Contact: Emily S. Miller, MD, MPHfirstname.lastname@example.org|
|Contact: Allie Sakowicz, BAemail@example.com|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Allie Sakowicz 312-503-9336 firstname.lastname@example.org|
|Principal Investigator:||Emily S. Miller, MD, MPH||Northwestern University|