A Phase 4 interventional study of Magnesium Sulfate and Magnesium Sulfate in Preeclampsia Severe and Preeclampsia Postpartum, sponsored by Alexander Harrison. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Alexander Harrison · Phase 4, Interventional, and Treatment
Participants are recruited for a research study about how lab values change following delivery in people with Preeclampsia with Severe Features. Preeclampsia with Severe Features means that the disease has impacted organs, causing high blood pressures, symptoms, or changes in lab values. Those with Preeclampsia with Severe Features receive magnesium sulfate after delivery.
The study is intended to learn how lab values change following delivery and to investigate how quickly participants get better from preeclampsia. Participation in this research will last while admitted to the hospital. Information will be collected from the post partum visit, but there is no need for blood draw at that time. The purpose of this research is to gather information on the safety and effectiveness of a shorter administration of magnesium which is approved by the Food and Drug Administration (FDA).
Participants will be randomized into two groups, which means that it will be decided by chance if 12 hours or 24 hours of magnesium will be given after the delivery of the baby.
Blood samples will be collected at time of delivery, 12 hours after delivery, 18 hours after delivery, 24 hours after delivery, and then daily. This is very similar to the number of labs to be collected even if participants decide not to participate in this study. This would likely add 2 or 3 blood draws. Both groups will have the same number of blood draws collected.
Other than possibly having 12 hours of magnesium, and a few more blood draws, the rest of the care received will not change. Each blood draw will consist of \~10mL, meaning a total of about 40mL of blood would be drawn for the purpose of this study.
Data would be collected, and deidentified. Information collected would include age, other medical conditions (like diabetes or high blood pressure out side of pregnancy), blood pressure, and symptoms during hospital stay and at the post partum visit.
The research procedures, including patient enrollment, will occur while admitted to the Labor and Delivery Unit at University of Kentucky Chandler Hospital prior to birth, and no additional visits for the purpose of this research are anticipated. The experimental group will include pregnant participants with preeclampsia with severe features who are randomized to 12 hours of magnesium post-partum. The control group will consist of participants with preeclampsia with severe features randomized to 24 hours of magnesium administration post-partum.
After their initial enrollment, care will not be impacted leading up to the delivery of the neonate. Following delivery, the magnesium sulfate administration will remain a continuous infusion at 2 grams per hour (diluted in lactated ringers for total infusion volume of 50mL per hour) as is standard practice. Care for both groups will remain as standard for nursing monitoring including exam and vital signs at least hourly while on magnesium sulfate continuous infusion.
Both groups at completion of magnesium sulfate, either 12 hours after delivery for the intervention group or 24 hours after delivery for control group, will continue with standard monitoring procedures per institutional protocol.
Both groups will have blood (serum) analysis collected at time of delivery, 12 hours later, then at 18 hours following delivery, and 24 hours. After 24 hours of collection, the lab evaluation will be spaced to daily until discharge. While laboratory evaluation, being collected and analyzed, every 6 hours is a standard practice for many clinical circumstances while admitted for pre-eclampsia with severe features, there is the potential to increased cost if not felt to be clinically indicated post-partum. This cost would not be passed along to patients and would instead be covered by funding acquired for this study. Additionally, some of the serum analytes collected, such as soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF) are not part of routine analysis, and costs will be covered by research funding rather than billed to patients.
Analysis will consist of typical preeclampsia markers such as liver transaminases, serum creatinine, platelet counts. Additional analytes will include sFlt-1, PlGF, intracellular adhesion molecule (ICAM), vascular cell adhesion molecule (VCAM), B-type natriuretic peptide (BNP). Clinical analysis will consist of chart analysis floor policy but will include vital signs (blood pressure, respiratory rate, oxygen saturation, pulse), standard review of systems to assess for magnesium side effects/toxicity, and other evaluation that was clinically indicated based on patient status such as imaging if necessary. No clinical interventions will be altered by study protocol other than the determination of 12-hour or 24-hour magnesium sulfate administration post-partum. Patients will receive standard postpartum outpatient follow-up. No additional clinical visits related to the study will be necessary, and chart review will be completed until 6 weeks post-partum as that is the duration in which preeclampsia is anticipated to resolve.
Per floor policy, the magnesium bolus of 4g will already have been received prior to randomization, and the standard administration rate of 2g/hr will be continued through delivery, and into the post-partum period where the study takes place. Clinicians often adjust magnesium dosing in the setting of pulmonary edema, renal dysfunction (creatinine >1.1), or if concern presents for magnesium toxicity. If these concerns present, clinician judgement to alter magnesium dosing, or length of administration, will not be influenced.
The patient will continue in the study, with necessary annotations in the data analysis to specify these findings. Similarly, hemolysis elevated liver enzymes low platelets (HELLP) syndrome, eclampsia, persistent (non-improving) neurologic symptoms like a headache or vision change, would all necessitate 24-hour administration of magnesium given the underlying severity of the disease. The patients would be analyzed in their original group with intent-to-treat analysis.
Medical records will be abstracted to collect demographic information, medical and prenatal history, treatment course, information related to delivery and neonate after birth (Birth weight, gender, APGARS and neonatal complications). The blood samples collected during the study will be stored in a locked freezer behind locked doors in the participating laboratory. All identifiable information will be removed from the samples. All information will be de-identified and assigned unique identification codes before storing the specimens. Only the bank staff will have access to the master list that links the code to participants. All coded information in a secured computer behind locked doors. All digital information will be protected with passwords/encryption. Encryption changes the information to another format to protect it from being accessed by anyone outside of the approved staff.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →This is the only study on the registry with Alexander Harrison as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm would receive the typical 24 hours of post partum magnesium sulfate administration
Drug: Magnesium Sulfate
This arm would receive 12 hours of post partum magnesium sulfate administration
Drug: Magnesium Sulfate
The experimental group will receive 12 hours of magnesium sulfate post partum, as compared to the control group which will receive 24 hour administration
The control arm will receive 24 hours of magnesium sulfate administration post partum
Change in creatinine
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in alanine aminotransferase (ALT)
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in aspartate aminotransferase (AST)
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in sFlt-1
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in platelets
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in PlGF
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in BNP
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in VCAM
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in ICAM
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in tumor necrosis factor-alpha (TNF-alpha)
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in Uric acid
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in lactate dehydrogenase (LDH)
At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels.
Time frame: Day of delivery through discharge (up to 4 days)
Change in systolic blood pressure
Measured as millimeter of mercury (mmHg).
Time frame: Time of delivery through post partum visit (up to 6 weeks)
Change in diastolic blood pressure
Measured as millimeter of mercury (mmHg).
Time frame: Time of delivery through post partum visit (up to 6 weeks)
Change in mean arterial pressure
Measured as millimeter of mercury (mmHg).
Time frame: Time of delivery through post partum visit (up to 6 weeks)
Change in pulse rate
Measured in beats per minute (beats/min).
Time frame: Time of delivery through post partum visit (up to 6 weeks)
Change in urine output
urine output (measured as mL/kg/hr)
Time frame: Time of delivery through post partum visit (up to 6 weeks)
Incidence of adverse outcomes
patient reported symptoms (headache (reported as Y/N), visual disturbances (reported as Y/N as well as comment on type), epigastric pain (reported as Y/N)), physical exam findings (lower extremity clonus (reported as Y/N), other concerning findings (with comments available to describe if pulmonary changes, mental status change, or changes to reflexes).
Time frame: Time of delivery through post partum visit (up to 6 weeks)
1 minute APGAR Scores
APGAR scores (1 being lowest, 9 being highest)
Time frame: 1 minute following delivery
5 minute APGAR Score
APGAR scores (1 being lowest, 9 being highest)
Time frame: 5 minutes following delivery
10 minute APGAR Score
APGAR scores (1 being lowest, 9 being highest)
Time frame: 10 minutes following delivery
Gestational Age At Delivery
Gestational Age At Delivery (measured in weeks and decimal point to represent days)
Time frame: At time of delivery
Birthweight At Delivery
Newborn birthweight at delivery (grams)
Time frame: At time of delivery
Need for Neonatal Intensive Care Unit (NICU) Admission
Need for NICU admission (measured as a yes/no)
Time frame: During hospital admission(up to 6 days)
NICU Length of Stay
NICU length of stay (days)
Time frame: During neonatal hospital admission (up until 6months)
Neonatal Complications
Measured as free response for complications while admitted to hospital/NICU (ex. need for intubation, intraventricular hemorrhage)
Time frame: During neonatal hospital admission (up until 6months)
Mode of Delivery
Mode of delivery (reported as vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery)
Time frame: At time of birth
Feeding Type
Feeding type (reported as breast feeding, pumping, formula feeding)
Time frame: Up until 6 weeks post partum
Time until ambulation
Recorded time from delivery until documented ambulation (measured in hours)
Time frame: During hospital admission (up to 6 days)
Antihypertensive medication at time of discharge
Record of antihypertensive medication (name and dose in mg) at time of discharge
Time frame: During hospital admission (up to 6 days)
Antihypertensive Medication Administration at Post Partum visit (1 week)
Antihypertensive medication administration at 1 week follow up visit (medication name and dose in mg)
Time frame: 1 week post partum
Antihypertensive medication at post partum visit (6 weeks)
Antihypertensive medication administration at 6 week follow up visit (medication name and dose in mg)
Time frame: 6 weeks post partum
Plan to share: Yes — All collected variables (including screening criteria, diagnostic criteria, intervention, outcomes) will be shared, while individual patient identifiers will be removed.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The available information will be accessible at start of study, and remain available through publication
Access criteria: Those who request from the study PI will be considered for access
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.
Of 35 phase 4 interventional studies under Pre-Eclampsia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 35. This study's planned 6 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate