Skip to main content
OpenTrials
Completed

NCT Number: NCT02454322

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant or immediately postpartum women
  • Age 18 and over
  • Singleton gestation
  • Diagnosis of hypertensive disorder of pregnancy
  • Gestational age of at least 34 weeks
  • English-speaking

Exclusion criteria

  • Women not meeting the above criteria
  • Prior receipt of magnesium during pregnancy
  • Intrauterine fetal demise or neonatal demise
  • Chronic hypertension

Treatment and study plan

Magnesium sulfate

Drug

Standard of care Magnesium Sulfate given to women with a diagnosis of a hypertensive disorder of pregnancy.

Primary outcomes

  1. Frequency of Postpartum Depression

    Time frame: Up to 6 weeks

    The frequency of postpartum depression at 2 weeks and 6 weeks postpartum

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
May 27, 2015
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.