Patient SatisfactionNCT05789381
Patient Satisfaction With Abbreviated Postpartum Magnesium Sulfate for Severe Preeclampsia
A study testing Magnesium sulfate in people with Patient Satisfaction, run by University of Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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
About this study
Official title: Patient Satisfaction and Abbreviated Postpartum Magnesium Sulfate for Preeclampsia With Severe Features: a Randomized Controlled Trial
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.
Read the detailed description
- 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).
- 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.
- Conditions
- Patient Satisfaction
- Being tested
- Magnesium sulfate
- Keywords
- preeclampsia, pregnancy, postpartum, magnesium, satisfaction, breastfeeding
- Medical subject headings
- Patient Satisfaction, Pre-Eclampsia, Personal Satisfaction, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 24 hours postpartum magnesium sulfate | Active comparator | Not described Receives: Procedure: Magnesium sulfate |
| 12 hours postpartum magnesium sulfate | Experimental | Not described Receives: Procedure: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up until hospital discharge (assessed up until day 7)
Secondary outcomes (8)
Breastfeeding initiation
Measured by patients report of "yes" or "no".
Measured: Up until 12 weeks postpartum
Magnesium toxicity
Magnesium toxicity will be measured with the following possible criteria: lab values (magnesium >8.4 mg/dL) or symptoms (lethargy, altered mental status, hyporeflexia, pulmonary edema).
Measured: Up until 3 days postpartum
Worsening preeclampsia
Worsening preeclampsia will be measured as clinical findings such as persistent headache, vision changes and right upper quadrant pain by postpartum day #3 and postpartum day #7. Measured by number of participants with elevated blood pressures recorded through the remote monitoring system and/or at their postpartum visits.
Measured: Up until 7 days postpartum
Persistently elevated blood pressure
Persistently elevated blood pressure will be monitored by a home blood pressure cuff which is given to patients prior to hospital discharge when they have a diagnosis of preeclampsia. The home monitoring system is linked to a phone app which is already in use by the University of Chicago and triggers an alert when blood pressures are above 160 systolic or 110 diastolic. With a severe range blood pressure as described, an assessment by the physician on call is prompted. Persistently elevated blood pressures could also be mild range, meaning 140-159 systolic or 90-109 diastolic, and could prompt initiation of antihypertensive medication and would be included in outcomes measured for persistently elevated blood pressure.
Measured: Up until 7 days postpartum
Need for antihypertensive medication after discharge
The decision to begin antihypertensive medication after discharge is closely linked to persistently elevated blood pressures, which is up to the discretion of the managing physician, but would be given if there were persistently elevated blood pressures in the severe range, 160 systolic or 110 diastolic. Medication is often also initiated when blood pressures are persistently in the mild range (140-159 systolic or 90-109 diastolic), meaning that >50% of measured blood pressure are within these ranges.
Measured: Up until 12 weeks postpartum
Maternal complications
Pulmonary edema, seizure, ICU admission
Measured: Up until 12 weeks postpartum
Postpartum length of stay
Measured in days
Measured: Up until hospital discharge (assessed up until day 7)
Postpartum depression
The assessment of postpartum depression is a standard component of postpartum care. At the participant's postpartum visit they will be administered the Edinburgh Postnatal Depression Scale survey (EPDS). This consists of 10 questions, with a maximum score of 30. Possible depression is considered a score higher than 10. Questions 1, 2 and 4 are scored as 0, 1, 2, 3 and questions 3, 5, and 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. The final question asks about suicidal thoughts and always prompts further evaluation and assessment.
Measured: Up until 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Feasibility reassessed, study design reevaluated, project withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joana Lopes Perdigao, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789381
- Sponsor's protocol ID
- IRB22-0450
- Status last verified
- Oct 2024
- First submitted
- 1 Mar 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bell MJ. A historical overview of preeclampsia-eclampsia. J Obstet Gynecol Neonatal Nurs. 2010 Sep-Oct;39(5):510-8. doi: 10.1111/j.1552-6909.2010.01172.x.
PubMed 20919997Alexander 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.
PubMed 17012442Witlin 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.
PubMed 9794688Sibai 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.
PubMed 15284724Fontenot 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.
PubMed 15970809Vigil-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.
PubMed 28738788Altman 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.
PubMed 12057549Bergman 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.
PubMed 31375930Bain 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.
PubMed 24139447Anjum 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.
PubMed 26604159Beyuo 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.
PubMed 31641005Padda 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.
PubMed 34567870
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Abbreviated Postpartum Magnesium Sulfate for Preeclampsia With Severe Features: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05789381
- Acronym / sponsor ID
- IRB22-0450
- Conditions
- Patient Satisfaction
- Keywords
- preeclampsia, pregnancy, postpartum, magnesium, satisfaction, breastfeeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility reassessed, study design reevaluated, project withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hours postpartum magnesium sulfate | Active comparator | Procedure: Magnesium sulfate |
| 12 hours postpartum magnesium sulfate | Experimental | Procedure: Magnesium sulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Pregnancy >20 weeks EGA
Key exclusion criteria (8 listed)
- • AKI or h/o CKD ( Cr >1.1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateThis 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. | Procedure or surgery | 12 hours postpartum magnesium sulfate, 24 hours postpartum magnesium sulfate |
Primary outcome
Patient satisfaction
Time frame: Up until hospital discharge (assessed up until day 7)
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.
8 secondary outcomes
Breastfeeding initiation
Time frame: Up until 12 weeks postpartum
Magnesium toxicity
Time frame: Up until 3 days postpartum
Worsening preeclampsia
Time frame: Up until 7 days postpartum
Persistently elevated blood pressure
Time frame: Up until 7 days postpartum
Need for antihypertensive medication after discharge
Time frame: Up until 12 weeks postpartum
Maternal complications
Time frame: Up until 12 weeks postpartum
Postpartum length of stay
Time frame: Up until hospital discharge (assessed up until day 7)
Postpartum depression
Time frame: Up until 12 weeks postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 20919997Bell MJ. A historical overview of preeclampsia-eclampsia. J Obstet Gynecol Neonatal Nurs. 2010 Sep-Oct;39(5):510-8. doi: 10.1111/j.1552-6909.2010.01172.x.
- Background: PubMed 17012442Alexander 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.
- Background: PubMed 9794688Witlin 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.
- Background: PubMed 15284724Sibai 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.
- Background: PubMed 15970809Fontenot 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.
- Background: PubMed 28738788Vigil-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.
- Background: PubMed 12057549Altman 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.
- Background: PubMed 31375930Bergman 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.
- Background: PubMed 24139447Bain 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.
- Background: PubMed 26604159Anjum 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.
- Background: PubMed 31641005Beyuo 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.
- Background: PubMed 34567870Padda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joana Lopes Perdigao, MD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate in people with Patient Satisfaction, run by University of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Up until hospital discharge (assessed up until day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05789381, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.