Phase 4 N=66 Randomized Treatment

Magnesium Sulfate in Obese Preeclamptics

Preeclampsia

Bottom Line

View on ClinicalTrials.gov: NCT02835339 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Maternal Serum Magnesium Level at 4 Hours After Administration — 3.53; 4.41 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Magnesium sulfate 4g loading dose, 1g/hr infusion (Drug); Magnesium sulfate 6g loading dose, 2g/hr infusion (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Maternal Serum Magnesium Level at 4 Hours After Administration	3.53; 4.41	—
SECONDARY Maternal Serum Magnesium Level at Time of Delivery	3.73; 5.44	—
SECONDARY Maternal Side Effects	5.5; 10.5; 0; 5.2; 0; 0	—

Summary

The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

Eligibility Criteria

Inclusion Criteria

Pregnant women who are ages 18-45
32-42 weeks' pregnant
Prescribed magnesium sulfate for preeclampsia
BMI ≥35 kg/m2

Exclusion Criteria

Pregnant women < 32 weeks' pregnant
Women who are on dialysis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02835339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.