Clinical trial NCT02454322: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Postpartum
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Frequency of Postpartum Depression
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Cognitive Function (measured using the Salthouse Digit Comparison and Size Judgment Span tests)
timeFrame: 4 days
measure: Pain (Self-reported)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Emily S. Miller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: