Trial Outcomes & Findings for Assessment of a Syringe Pump to Pre-eclamptic Women in a Low-resource Hospital (NCT NCT02296931)

Results Overview

This is the error value for the volume dispensed by the AutoSyp device relative to the volume intended to be dispensed. Preeclamptic subjects received an initial loading dose followed by a maintenance dose. The loading dose had a flow rate of 60 mL/hr and delivered 20 mL in a single 20 mL syringe. The maintenance dose was 5 mL/hr and dispensed 120 mL total through two 60 mL syringes. The healthy subjects experienced variable flow rates and dispensed volumes, so they do not have the same variables as the pre-eclamptic pregnant women in the outcome data tables below. Because of these differences in dosing the two arms of the study, healthy women and preeclamptic women have different outcome measure data.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

1 day visit

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Adults Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. Saline: Standard IV Saline Fluids	Pre-eclamptic Pregnant Women In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)
Overall Study STARTED	10	24
Overall Study COMPLETED	10	22
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Adults Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. Saline: Standard IV Saline Fluids	Pre-eclamptic Pregnant Women In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)
Overall Study Protocol Violation	0	2

Baseline Characteristics

Assessment of a Syringe Pump to Pre-eclamptic Women in a Low-resource Hospital

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Adults n=10 Participants Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. Saline: Standard IV Saline Fluids	Pre-eclamptic Pregnant Women n=22 Participants In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)	Total n=32 Participants Total of all reporting groups
Age, Continuous	28 years n=5 Participants	26 years n=7 Participants	27 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Malawi	10 participants n=5 Participants	22 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day visit

This is the error value for the volume dispensed by the AutoSyp device relative to the volume intended to be dispensed. Preeclamptic subjects received an initial loading dose followed by a maintenance dose. The loading dose had a flow rate of 60 mL/hr and delivered 20 mL in a single 20 mL syringe. The maintenance dose was 5 mL/hr and dispensed 120 mL total through two 60 mL syringes. The healthy subjects experienced variable flow rates and dispensed volumes, so they do not have the same variables as the pre-eclamptic pregnant women in the outcome data tables below. Because of these differences in dosing the two arms of the study, healthy women and preeclamptic women have different outcome measure data.

Outcome measures

Outcome measures
Measure	Healthy Adults n=10 Participants Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. Saline: Standard IV Saline Fluids	Pre-eclamptic Pregnant Women n=22 Participants In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)
Error in the Total Volume Dispensed and Flow Rate Total Volume Dispensed-Loading Dose	NA percentage of error Healthy adults experienced variable dispensed volumes in contrast to the fixed volumes dispensed for the pre-eclamptic arm. This category is only for the error experienced by the pre-eclamptic arm regarding their fixed loading dose volume of 20mL	-1.48 percentage of error Interval -2.58 to -0.58
Error in the Total Volume Dispensed and Flow Rate Flow Rate-Loading Dose	NA percentage of error Healthy adults experienced variable flow rates in contrast to the fixed flow rates of the pre-eclamptic arm. This category is only for the error experienced by the pre-eclamptic arm regarding their loading dose flow rate of 60mL/hr.	-1.75 percentage of error Interval -2.53 to -1.47
Error in the Total Volume Dispensed and Flow Rate Total Volume Dispensed-Maintenance Dose	NA percentage of error Healthy adults had variable dispensed volumes in contrast to the fixed volumes dispensed for the pre-eclamptic arm. This category is for the error experienced by the pre-eclamptic arm regarding their maintenance dose dispensed volume of 120mL .	-1.13 percentage of error Interval -2.28 to -0.41
Error in the Total Volume Dispensed and Flow Rate Flow Rate-Maintenance Dose	NA percentage of error Healthy adults experienced variable flow rates in contrast to the fixed flow rates for the pre-eclamptic arm. This category is only for the error experienced by the pre-eclamptic arm regarding their maintenance dose flow rate of 5mL/hr.	-1.11 percentage of error Interval -2.09 to -0.76
Error in the Total Volume Dispensed and Flow Rate Flow Rate-Variable	-0.21 percentage of error Interval -2.9 to 4.95	NA percentage of error Healthy adult women experienced variable flow rates in contrast to the fixed flow rates for the pre-eclamptic arm. This category is only for the variable flow rate error experienced by the health adult arm.
Error in the Total Volume Dispensed and Flow Rate Total Volume Dispensed-Variable	-1.07 percentage of error Interval -3.65 to 2.6	NA percentage of error Healthy adult women experienced variable dispensed volumes in contrast to the fixed volumes dispensed for the pre-eclamptic arm. This category is only for the error in total volume dispensed experienced by the healthy adult arm.

Adverse Events

Healthy Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-eclamptic Pregnant Women

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

Dr. Rebecca Richards-Kortum

Rice 360: Institute for Global Health

Phone: 713-348-3823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place