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Trial record 23 of 110 for:    test | ( Map: Malawi )

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

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ClinicalTrials.gov Identifier: NCT02296931
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : October 5, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
University of Malawi
Information provided by (Responsible Party):
Rebecca Richards-Kortum, William Marsh Rice University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pre-eclampsia
Interventions Other: Saline
Drug: Magnesium Sulfate
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Adults Pre-eclamptic Pregnant Women
Hide Arm/Group Description

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

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)

Period Title: Overall Study
Started 10 24
Completed 10 22
Not Completed 0 2
Reason Not Completed
Protocol Violation             0             2
Arm/Group Title Healthy Adults Pre-eclamptic Pregnant Women Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 10 22 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 22 participants 32 participants
28
(23 to 50)
26
(19 to 37)
27
(19 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 22 participants 32 participants
Female
10
 100.0%
22
 100.0%
32
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malawi Number Analyzed 10 participants 22 participants 32 participants
10 22 32
1.Primary Outcome
Title Error in the Total Volume Dispensed and Flow Rate
Hide Description 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.
Time Frame 1 day visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Adults Pre-eclamptic Pregnant Women
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 10 22
Mean (Full Range)
Unit of Measure: percentage of error
Total Volume Dispensed-Loading Dose
NA [1] 
(NA to NA)
-1.48
(-2.58 to -0.58)
Flow Rate-Loading Dose
NA [2] 
(NA to NA)
-1.75
(-2.53 to -1.47)
Total Volume Dispensed-Maintenance Dose
NA [3] 
(NA to NA)
-1.13
(-2.28 to -0.41)
Flow Rate-Maintenance Dose
NA [4] 
(NA to NA)
-1.11
(-2.09 to -0.76)
Flow Rate-Variable
-0.21
(-2.90 to 4.95)
NA [5] 
(NA to NA)
Total Volume Dispensed-Variable
-1.07
(-3.65 to 2.60)
NA [6] 
(NA to NA)
[1]
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
[2]
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.
[3]
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 .
[4]
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.
[5]
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.
[6]
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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Adults Pre-eclamptic Pregnant Women
Hide Arm/Group Description

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

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)

All-Cause Mortality
Healthy Adults Pre-eclamptic Pregnant Women
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Adults Pre-eclamptic Pregnant Women
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Adults Pre-eclamptic Pregnant Women
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Rebecca Richards-Kortum
Organization: Rice 360: Institute for Global Health
Phone: 713-348-3823
Responsible Party: Rebecca Richards-Kortum, William Marsh Rice University
ClinicalTrials.gov Identifier: NCT02296931     History of Changes
Other Study ID Numbers: 14-081F
First Submitted: November 18, 2014
First Posted: November 21, 2014
Results First Submitted: June 24, 2016
Results First Posted: October 5, 2016
Last Update Posted: November 6, 2017