Patient Satisfaction With Abbreviated Postpartum Magnesium Sulfate for Severe Preeclampsia

NCT05789381 | Withdrawn DMC

• 1 other identifier: IRB22-0450
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preeclampsia is a common and potentially devastating disease that affects only pregnant or postpartum patients. It is a leading cause of maternal mortality not only worldwide, but in the United States as well. As the medical field has advanced in many regards, including improved treatment for prevention of severe preeclampsia or even eclamptic seizures, the strain on pregnant and postpartum people has remained relatively unchanged. The most successful and widely used management of severe preeclampsia is magnesium sulfate, an intravenous infusion used to help prevent eclamptic seizures which can be additionally life threatening. While magnesium can be efficacious, it comes with some hindrances. Notably, magnesium itself can make patients feel ill-weak, confused, lethargic, "foggy", and even somnolent in cases of toxicity. Other adverse effects include pulmonary edema, and cardiac arrhythmias or even coma. These effects are common and concerning enough that it is regular practice to examine patients at the bedside with a full neurological exam every 2 hours while they are on magnesium, which is typically a course of at least 24 hours straight. Additionally, patients typically have a foley catheter in place to monitor urine output as magnesium can cause kidney injury, and they are bedbound because of the lethargy and concern for falls. In the postpartum period this has significant negative impacts on patients bonding with their newborn, initiating breast or chest feeding, walking, voiding, and aiding in faster postpartum recovery. While the implications of a life threatening medical diagnosis are devastating for many patients, the trauma that can be caused by being away from a patient's newborn or not feeling in control of the patients own body postpartum are issues that are finally starting to be recognized. While magnesium is necessary, there may be ways to treat patients while maintaining independence, mental health and sense of selves especially in the sensitive postpartum period. The investigators hypothesis is that, in a carefully selected group of patients with severe preeclampsia, 12 hours of magnesium sulfate leads to improved patient satisfaction, increased breastfeeding postpartum, as well as other markers of enhanced postpartum recovery, and lack of worsening symptoms or persistently elevated blood pressure in comparison to 24 hours of magnesium.

Conditions

Patient Satisfaction

Keywords

preeclampsia; pregnancy; postpartum; magnesium; satisfaction; breastfeeding

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Patient satisfaction will be measured using the WOMB postnatal satisfaction questionnaire (WOMBPNSQ) which is a standardized survey instrument for postpartum patient satisfaction. This survey instrument has multiple versions with the most recent version consisting of 39 questions, measured on a Likert scale with answers ranging from 1 (least) to 7 (most). The higher scores will mean a better outcome or better patient satisfaction.

  Up until hospital discharge (assessed up until day 7)

Secondary Outcomes (8)

• Breastfeeding initiation

  Up until 12 weeks postpartum

• Magnesium toxicity

  Up until 3 days postpartum

• Worsening preeclampsia

  Up until 7 days postpartum

• Persistently elevated blood pressure

  Up until 7 days postpartum

• Need for antihypertensive medication after discharge

  Up until 12 weeks postpartum

Study Arms (2)

24 hours postpartum magnesium sulfate

ACTIVE COMPARATOR

Procedure: Magnesium sulfate

12 hours postpartum magnesium sulfate

EXPERIMENTAL

Procedure: Magnesium sulfate

Interventions

Magnesium sulfate PROCEDURE

This drug is commonly used on labor and delivery and in the postpartum period and is easily ordered through the electronic medical record and provided. This drug requires no specific storage for research study purposes as the drug is already being administered per standard of care and national and international guidelines. The only change is in the duration of therapy. This is NOT considered an off label use of the drug and does not require any form of exemption determination. Magnesium for severe preeclampsia is often given for anywhere from 12 to 24 hours postpartum depending on the clinical scenario, provider preference, and patient symptoms/adverse reactions to the medication.

12 hours postpartum magnesium sulfate; 24 hours postpartum magnesium sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy \>20 weeks EGA
• Age 18 to 50
• English speaking
• Pre-eclampsia or superimposed pre-eclampsia with severe features diagnosed prior to delivery (antepartum), during labor and delivery (intrapartum)
• Diagnosis of preeclampsia with severe features diagnosed undergoing induction of labor, spontaneous labor, or cesarean delivery (scheduled or unscheduled) delivering at the University of Chicago Family Birth Center
• \*Pre-eclampsia: is defined as new onset hypertension in pregnancy after 20 weeks gestation with proteinuria.
• Pre-eclampsia with severe features may occur with or without proteinuria if ANY one of the following "severe features" are diagnosed: blood pressure \>160/\>110 sustained over 2 values 15 minutes apart, creatinine \>1.1 or double patient baseline, liver function tests/AST and ALT double the upper limit of normal, persistent headache despite medication, pulmonary edema, right upper quadrant pain, platelet count \<100,000.

You may not qualify if:

• AKI or h/o CKD ( Cr \>1.1)
• HELLP syndrome (LFT's twice the upper limit of normal or platelets \<100 not secondary to gestational or idiopathic thrombocytopenia with evidence of hemolysis by LDH levels or schistocytes on blood smear).
• Eclampsia
• Uncontrollable blood pressures requiring higher level of care such as in the intensive care unit
• Diuresis \< 30cc/kg /hr
• Patients with neurologic signs or symptoms such as headache that does not remit with medication, blurred vision
• Patients with ongoing right upper quadrant pain as a symptom of pre-eclampsia
• Patients with other contraindications to magnesium prophylaxis such as myasthenia gravis, pulmonary edema

Sponsors & Collaborators

• University of Chicago: lead

Related Publications (12)

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  PMID: 20919997 BACKGROUND

• Alexander JM, McIntire DD, Leveno KJ, Cunningham FG. Selective magnesium sulfate prophylaxis for the prevention of eclampsia in women with gestational hypertension. Obstet Gynecol. 2006 Oct;108(4):826-32. doi: 10.1097/01.AOG.0000235721.88349.80.

  PMID: 17012442 BACKGROUND

• Witlin AG, Sibai BM. Magnesium sulfate therapy in preeclampsia and eclampsia. Obstet Gynecol. 1998 Nov;92(5):883-9. doi: 10.1016/s0029-7844(98)00277-4.

  PMID: 9794688 BACKGROUND

• Sibai BM. Magnesium sulfate prophylaxis in preeclampsia: Lessons learned from recent trials. Am J Obstet Gynecol. 2004 Jun;190(6):1520-6. doi: 10.1016/j.ajog.2003.12.057.

  PMID: 15284724 BACKGROUND

• Fontenot MT, Lewis DF, Frederick JB, Wang Y, DeFranco EA, Groome LJ, Evans AT. A prospective randomized trial of magnesium sulfate in severe preeclampsia: use of diuresis as a clinical parameter to determine the duration of postpartum therapy. Am J Obstet Gynecol. 2005 Jun;192(6):1788-93; discussion 1793-4. doi: 10.1016/j.ajog.2004.12.056.

  PMID: 15970809 BACKGROUND

• Vigil-De Gracia P, Ramirez R, Duran Y, Quintero A. Magnesium sulfate for 6 vs 24 hours post delivery in patients who received magnesium sulfate for less than 8 hours before birth: a randomized clinical trial. BMC Pregnancy Childbirth. 2017 Jul 24;17(1):241. doi: 10.1186/s12884-017-1424-3.

  PMID: 28738788 BACKGROUND

• Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.

  PMID: 12057549 BACKGROUND

• Bergman L, Torres-Vergara P, Penny J, Wikstrom J, Nelander M, Leon J, Tolcher M, Roberts JM, Wikstrom AK, Escudero C. Investigating Maternal Brain Alterations in Preeclampsia: the Need for a Multidisciplinary Effort. Curr Hypertens Rep. 2019 Aug 2;21(9):72. doi: 10.1007/s11906-019-0977-0.

  PMID: 31375930 BACKGROUND

• Bain ES, Middleton PF, Crowther CA. Maternal adverse effects of different antenatal magnesium sulphate regimens for improving maternal and infant outcomes: a systematic review. BMC Pregnancy Childbirth. 2013 Oct 21;13:195. doi: 10.1186/1471-2393-13-195.

  PMID: 24139447 BACKGROUND

• Anjum S, Goel N, Sharma R, Mohsin Z, Garg N. Maternal outcomes after 12hours and 24hours of magnesium sulfate therapy for eclampsia. Int J Gynaecol Obstet. 2016 Jan;132(1):68-71. doi: 10.1016/j.ijgo.2015.06.056. Epub 2015 Oct 14.

  PMID: 26604159 BACKGROUND

• Beyuo T, Lawrence E, Langen ES, Oppong SA. Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol. BMJ Open. 2019 Oct 22;9(10):e032799. doi: 10.1136/bmjopen-2019-032799.

  PMID: 31641005 BACKGROUND

• Padda J, Khalid K, Colaco LB, Padda S, Boddeti NL, Khan AS, Cooper AC, Jean-Charles G. Efficacy of Magnesium Sulfate on Maternal Mortality in Eclampsia. Cureus. 2021 Aug 20;13(8):e17322. doi: 10.7759/cureus.17322. eCollection 2021 Aug.

  PMID: 34567870 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Pre-Eclampsia; Personal Satisfaction; Breast Feeding

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Joana Lopes Perdigao, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 29, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share