Clinical trial NCT05789381: Patient Satisfaction With Abbreviated Postpartum Magnesium Sulfate for Severe Preeclampsia
Official title: Patient Satisfaction and Abbreviated Postpartum Magnesium Sulfate for Preeclampsia With Severe Features: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Patient Satisfaction
Keywords: preeclampsia
pregnancy
postpartum
magnesium
satisfaction
breastfeeding
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 1. Visit 1: the screening, consent and randomization visit. This takes place in the Family Birth Center as described above. The patient is approached for consent, randomized, and receives the study intervention in the postpartum period. Randomization will be performed through REDCap using permuted block technique. A permuted block randomization procedure will be used to formulate assignment lists in order to assure close to equal numbers of subjects in each treatment group. A uniform block size of 4 will be used, and the allocation ratio within each unit will be 1. A list of random digits (0-9) will be generated by a computer based random number generator. The list will then be transformed into a randomization schedule. Using a block size of four subjects, with four potential treatment groups, a permutation block assignment list will be created. Because of the block size, an allocation ratio of 1 will be assured after each subsequent group of eight subjects is allocated. Randomization will be performed using a computer-generated sequence in two blocks. Sequentially numbered opaque envelopes displaying only the randomization number on the outside will then be used. These envelopes will be stored in a locked closet on the labor and delivery unit.

   Blinding: Given the nature of the study, neither patients nor the covering provider can be blinded.

   Prior to discharge, patients receive the WOMB postnatal satisfaction questionnaire (WOMBPNSQ) and this is all considered the same visit (the labor and delivery visit).
2. Visit 2: this refers to the Postpartum visit. At anywhere from 2 to 12 weeks postpartum, the patient will come to see their provider for follow up care. At this visit, it is standard of care to collect the EDPS depression survey. This score will be collected for study data from the electronic medical record.

Patients will be approached if they have a diagnosis of preeclampsia with severe features. Patients who consent to participate in the study and are eligible will be randomized into 24 hours of magnesium therapy or 12 hours of magnesium therapy in the postpartum period. Magnesium levels will be obtained if indicated by standard protocol by patient symptoms and will be defined as magnesium level greater than 8.4 mg/dL or symptoms such as hyporeflexia, pulmonary edema, altered mental status. Patients will be asked to complete two surveys in the postpartum period, one for depression scoring and one for patient satisfaction in the postpartum period. The patient satisfaction survey will be administered prior to discharge from the hospital postpartum. The depression score survey will be administered at the patient's postpartum visit, as is the standard of care at all postpartum visits regardless of medical diagnoses.

Progression of symptoms/presence of symptoms is something that is subjectively measured by the physician team when rounding on the patient, by the nurses when assessing the patient, and is clearly documented in progress notes throughout the day and the patient's inpatient admission. Blood pressures are documented in the chart at regular intervals when they are recorded on the floor, and are easily accessed in the Vitals section of the EMR. The investigators outcome measure is not "improved" breastfeeding, but breastfeeding as a binomial variable (yes/no) and this is also clearly documented in the chart in progress note from the physician team, nursing team, and lactation team. This measure is regularly recorded within the investigators department for data collection for the entire Family Birthing Center. I have previously deleted maternal-neonatal bonding as an outcome measure, this is no longer a measure in investigators study. Magnesium toxicity is first suspected clinically and would be documented in the progress note section of the EMR, and it is confirmed with serum measurement of magnesium level (\>8.4). This is documented in the Results Review/Laboratory section of the EMR and is easily accessible in the chart. Patient/maternal satisfaction with birth experience and postnatal experience will be evaluated by the WOMBPNSQ survey and postpartum depression will be evaluated by the Edinburgh survey.

Foley catheter removal is documented by nursing in the intake/output section of the medical record. Time to ambulation will be extrapolated by rounding notes from the care team.

Continuation/discontinuation rules: if the patient is randomized to the 12 hour magnesium arm and has worsening labs, uncontrollable blood pressures, or worsening headache/neurologic symptoms, they are deemed at a higher risk of eclamptic seizure and will therefore receive a full 24 hours of magnesium as is the standard of medical care. They will remain enrolled in the study, not be withdrawn, and be analyzed by intention to treat as they were randomized to the 12 hour arm. If the patient is randomized to the 24 hour arm, they will continue until 24 hours unless they have signs/symptoms of magnesium toxicity or if they self-withdraw from the study arm.

Length of study: For the individual patient, involvement in the study will last from enrollment until the postpartum appointment, which may be as far out as 10-12 weeks postpartum. Access to the patient's chart and information for the purposes of data extraction and analysis and completion of the study, manuscript preparation and submission, will last up to 3 years. The investigators will continue to store this information for 3 years before destroying all data collected.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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

Primary outcomes:
measure: Patient satisfaction
timeFrame: Up until hospital discharge (assessed up until day 7)
Secondary outcomes:
measure: Breastfeeding initiation
timeFrame: Up until 12 weeks postpartum
measure: Magnesium toxicity
timeFrame: Up until 3 days postpartum
measure: Worsening preeclampsia
timeFrame: Up until 7 days postpartum
measure: Persistently elevated blood pressure
timeFrame: Up until 7 days postpartum
measure: Need for antihypertensive medication after discharge
timeFrame: Up until 12 weeks postpartum
measure: Maternal complications
timeFrame: Up until 12 weeks postpartum
measure: Postpartum length of stay
timeFrame: Up until hospital discharge (assessed up until day 7)
measure: Postpartum depression
timeFrame: Up until 12 weeks postpartum
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Joana Lopes Perdigao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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