Trial Outcomes & Findings for Magnesium Sulfate in Obese Preeclamptics (NCT NCT02835339)
NCT ID: NCT02835339
Last Updated: 2020-05-13
Results Overview
magnesium level in mg/dL
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
4 hours
Results posted on
2020-05-13
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
35
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Did not receive allocated intervention
|
13
|
16
|
Baseline Characteristics
Magnesium Sulfate in Obese Preeclamptics
Baseline characteristics by cohort
| Measure |
MgSO4 4g Load, 1g/hr Infusion
n=18 Participants
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
|
MgSO4 6g Load, 2g/hr Infusion
n=19 Participants
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
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.9 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
31.6 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
31.3 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
BMI
|
41 Kg/m^2
n=5 Participants
|
42 Kg/m^2
n=7 Participants
|
41 Kg/m^2
n=5 Participants
|
|
Multiparity
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Baseline Creatinine
|
0.6 mg/dL
n=5 Participants
|
0.67 mg/dL
n=7 Participants
|
0.6 mg/dL
n=5 Participants
|
|
Time to delivery
|
14.7 Hours
n=5 Participants
|
22.0 Hours
n=7 Participants
|
19.3 Hours
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursmagnesium level in mg/dL
Outcome measures
| Measure |
MgSO4 4g Load, 1g/hr Infusion
n=18 Participants
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
|
MgSO4 6g Load, 2g/hr Infusion
n=19 Participants
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
|
|---|---|---|
|
Maternal Serum Magnesium Level at 4 Hours After Administration
|
3.53 mg/dL
Standard Deviation .3
|
4.41 mg/dL
Standard Deviation .5
|
SECONDARY outcome
Timeframe: Within 20 minutes of deliverymagnesium level in mg/dL
Outcome measures
| Measure |
MgSO4 4g Load, 1g/hr Infusion
n=18 Participants
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
|
MgSO4 6g Load, 2g/hr Infusion
n=19 Participants
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
|
|---|---|---|
|
Maternal Serum Magnesium Level at Time of Delivery
|
3.73 mg/dL
Standard Deviation 0.7
|
5.44 mg/dL
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 4 hoursPresence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression
Outcome measures
| Measure |
MgSO4 4g Load, 1g/hr Infusion
n=18 Participants
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
|
MgSO4 6g Load, 2g/hr Infusion
n=19 Participants
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
|
|---|---|---|
|
Maternal Side Effects
Nausea
|
5.5 percentage of participants
|
10.5 percentage of participants
|
|
Maternal Side Effects
Flushing
|
0 percentage of participants
|
5.2 percentage of participants
|
|
Maternal Side Effects
Lethargy
|
0 percentage of participants
|
0 percentage of participants
|
|
Maternal Side Effects
Palpitations
|
0 percentage of participants
|
0 percentage of participants
|
|
Maternal Side Effects
Pain at IV site
|
0 percentage of participants
|
0 percentage of participants
|
|
Maternal Side Effects
Respiratory depression
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
MgSO4 4g Load, 1g/hr Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MgSO4 6g Load, 2g/hr Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kathleen Brookfield, MD, PhD, MPH
Oregon Health and Science University
Phone: 503-494-2101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place