Preeclampsia
Conditions
Brief 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.
Detailed description
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. Magnesium sulfate is generally given to patients to protect the mother against seizures in the case of preeclampsia. Different hospitals in the United States use different doses of magnesium sulfate. Participants will receive one of two accepted doses of magnesium sulfate for preeclampsia. The dose is usually 4g - 6g at the start, with another dose of 2-3 g every hour until 24 hours after delivery. Participants will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete. Participants will receive magnesium sulfate in the course of their normal clinical care whether or not they participate in this study.
Interventions
DRUGMagnesium sulfate 4g loading dose, 1g/hr infusion
DRUGMagnesium sulfate 6g loading dose, 2g/hr infusion
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Serum Magnesium Level at 4 Hours After Administration | 4 hours | magnesium level in mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Serum Magnesium Level at Time of Delivery | Within 20 minutes of delivery | magnesium level in mg/dL |
| Maternal Side Effects | 4 hours | Presence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression |
Countries
United States
Participant flow
Pre-assignment details
66 Women were consented, enrolled and assigned a study arm for this study. However, this was prior to clinical need for intervention, therefore several women who were enrolled in the study did not show clinical need for intervention.
Participants by arm
| Arm | Count |
|---|---|
| MgSO4 4g Load, 1g/hr Infusion Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.
Magnesium sulfate 4g loading dose, 1g/hr infusion | 18 |
| MgSO4 6g Load, 2g/hr Infusion Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.
Magnesium sulfate 6g loading dose, 2g/hr infusion | 19 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive allocated intervention | 13 | 16 |
Baseline characteristics
| Characteristic | MgSO4 6g Load, 2g/hr Infusion | MgSO4 4g Load, 1g/hr Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 18 Participants | 37 Participants |
| Age, Continuous | 31.6 Years STANDARD_DEVIATION 7.1 | 30.9 Years STANDARD_DEVIATION 6.6 | 31.3 Years STANDARD_DEVIATION 6.8 |
| Baseline Creatinine | 0.67 mg/dL | 0.6 mg/dL | 0.6 mg/dL |
| BMI | 42 Kg/m^2 | 41 Kg/m^2 | 41 Kg/m^2 |
| Multiparity | 11 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 19 participants | 18 participants | 37 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time to delivery | 22.0 Hours | 14.7 Hours | 19.3 Hours |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 |
| other Total, other adverse events | 0 / 18 | 0 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
Maternal Serum Magnesium Level at 4 Hours After Administration
magnesium level in mg/dL
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MgSO4 4g Load, 1g/hr Infusion | Maternal Serum Magnesium Level at 4 Hours After Administration | 3.53 mg/dL | Standard Deviation 0.3 |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Serum Magnesium Level at 4 Hours After Administration | 4.41 mg/dL | Standard Deviation 0.5 |
Secondary
Maternal Serum Magnesium Level at Time of Delivery
magnesium level in mg/dL
Time frame: Within 20 minutes of delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MgSO4 4g Load, 1g/hr Infusion | Maternal Serum Magnesium Level at Time of Delivery | 3.73 mg/dL | Standard Deviation 0.7 |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Serum Magnesium Level at Time of Delivery | 5.44 mg/dL | Standard Deviation 1 |
Secondary
Maternal Side Effects
Presence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression
Time frame: 4 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MgSO4 4g Load, 1g/hr Infusion | Maternal Side Effects | Nausea | 5.5 percentage of participants |
| MgSO4 4g Load, 1g/hr Infusion | Maternal Side Effects | Flushing | 0 percentage of participants |
| MgSO4 4g Load, 1g/hr Infusion | Maternal Side Effects | Lethargy | 0 percentage of participants |
| MgSO4 4g Load, 1g/hr Infusion | Maternal Side Effects | Palpitations | 0 percentage of participants |
| MgSO4 4g Load, 1g/hr Infusion | Maternal Side Effects | Pain at IV site | 0 percentage of participants |
| MgSO4 4g Load, 1g/hr Infusion | Maternal Side Effects | Respiratory depression | 0 percentage of participants |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Side Effects | Pain at IV site | 0 percentage of participants |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Side Effects | Nausea | 10.5 percentage of participants |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Side Effects | Palpitations | 0 percentage of participants |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Side Effects | Flushing | 5.2 percentage of participants |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Side Effects | Respiratory depression | 0 percentage of participants |
| MgSO4 6g Load, 2g/hr Infusion | Maternal Side Effects | Lethargy | 0 percentage of participants |