Pre-eclampsiaPhase 1/2NCT02296931
Assessment of a Syringe Pump to Pre-eclamptic Women in a Low-resource Hospital
A Phase 1/2 study testing Saline and Magnesium Sulfate in people with Pre-eclampsia, run by William Marsh Rice University at 1 site in Malawi.
Trial summary
Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted and relatively inexpensive treatment for these conditions, barriers to delivery via IV injection in low-resource settings pose a large obstacle to reductions in mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-eclampsia
- What is being tested?
- Saline and Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMalawi
- Study dates
- Mar 2015to 3 Oct 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Provide informed consent
- Agree to comply with study procedures
- Deemed medically stable by their healthcare provider, including normal range blood pressure.
- Have been clinically identified to be able to receive standard IV saline fluid
- 18 years of age or older
Show all 11Show fewer
- Provide informed consent
- Agree to comply with study procedures
- Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
- Be pregnant or are <24 hours postpartum.
- Diagnosed with pre-eclampsia and deemed to benefit from treatment with MGSO4 by healthcare providers
Who cannot join
- Women with a history of heart disease of cardiac complications.
- Women with a history of complications with an IV.
- Phase 2: Pre-eclamptic Women
- Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
- Be pregnant or are <24 hours postpartum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laboratory and Pilot Clinical Assessment of the Accuracy, Usability, and Function of a Low-cost, Low-power Syringe Pump in Administering Magnesium Sulfate to Pre-eclamptic Women in a Low-resource Hospital
Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted and relatively inexpensive treatment for these conditions, barriers to delivery via IV injection in low-resource settings pose a large obstacle to reductions in mortality. AutoSyP is a low-cost, low-powered automatic syringe pump that could overcome this barrier to the delivery of MgSO4. We propose to conduct a pilot clinical evaluation of its ability to deliver MgSO4 to women with pre-eclampsia or eclampsia in Malawi.
AutoSyP will be the subject of a 2 phase pilot clinical community trial in Malawi. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use to ensure proper procedures are followed. Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. The study will continue to Phase 2 where, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
Read more
- Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use.
- Eligible and willing participants will provide informed consent. Then, baseline demographic and relevant medical history information will be collected.
- In Phase 1, subjects will receive IV saline fluids by the Nurse. In Phase 2, the Nurse will provide loading dose of MgSO4 with the AutoSyP and research staff will monitor and record device performance and treatment specifications.
- Subsequent maintenance doses of saline or MgSO4 will be administered and observations monitored and recorded for up to 24 hours as clinically indicated.
Others may benefit from this study in the future as AutoSyP is a new delivery system is needed to break down the barriers to IV delivery of MgSO4 in low-resource settings. The results of this study will be made available to the Ministry of Health, NHSRC, COMREC, the College of Medicine Library, the Department of Paediatrics, and other partners working in neonatal and child health. Findings will be published in academic journals and conference proceedings in an effort to disseminate results to potential end-users. The research findings of this study will be critical in the evaluation of future interventions.
Read the detailed description
The study will recruit patients from two clinical sites (Kamuzu Central Hospital in Lilongwe, Malawi and Queen Elizabeth Central Hospital in Blantyre, Malawi) through their healthcare providers. Malawi represents an ideal location to conduct such a study as there are approximately 17,000 cases of pre-eclampsia annually. The study will include up to 40 women presenting with symptoms of pre-eclampsia.
The study will include pregnant women diagnosed with pre-eclampsia deemed to benefit from treatment with MgSO4 by healthcare providers at our participating clinical sites. Women who are eclamptic or seizing at the time of enrollment or have received MgSO4 therapy within the preceding 24 hours prior to study enrollment will be ineligible.
We will conduct an interventional study of the use of AutoSyP to deliver MgSO4 in two clinical setting in Malawi; Queen Elizabeth Central Hospital and Kamuzu Central Hospital. The study will be open and non-blinded due to ethical considerations that would arise from the denial of the experimental treatment to participants when there is no alternative form of IV MgSO4 delivery available.
All eligible and consenting women will be assigned to have treatment with AutoSyP if an AutoSyP device is available. If an AutoSyP device is not available, the participant will receive treatment for pre-eclampsia according to the standard of care at the hospital.
Pilot Clinical Evaluation Training
- Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use.
- All trained nurses will receive an identification number that will be used for recordkeeping throughout the study.
Selection of Participants
- Participants will be identified using the eligibility criteria stipulated above.
- Willing participants will provide informed consent to participate in the study.
- A participant identification number will be assigned. This number will be used for identification purposes throughout the study.
- Baseline demographic and relevant medical history information will be collected.
Treatment
- Nurse will provide loading dose with the AutoSyP. A trained Rice research assistant will observe all procedures and will correct any errors made by the nurse or answer any questions from the nurse.
- The Rice research assistant will monitor the performance of the AutoSyP, watching for any device malfunctions and notify the nurse if any are observed. The Rice research assistant will help the nurse to correct the device malfunction and treatment will continue; otherwise, an alternative AutoSyP device will be used to continue treatment. The research assistant will also use a timer to record the duration of the dose.
- The research assistant will record the following information:
- MgSO4 concentration used and syringe size
- Duration of administration
- Initial device set-up errors/questions by the nurse (e.g., user cannot operate device, user must ask for help)
- Observed malfunctions of AutoSyP
- Identification number of the nurse operating AutoSyP
- Identification number of the device
- Nurse provides maintenance doses with AutoSyP after the loading dose is complete.
- Rice research assistant repeats tasks 2-3 with reference to the maintenance dose.
- Nurse continues to provide maintenance doses for up to 24 hours as necessary.
- Rice research assistant repeats tasks 2-3 for each maintenance dose.
- Treatment will be discontinued when clinically indicted.
- Rice research assistant records the total number of doses provided and the clinical outcome of the patient.
- Conditions
- Pre-eclampsia
- Being tested
- Saline, Magnesium Sulfate
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
Standard IV Saline Fluids
Magnesium SulfateDrug
Also called MgSO4
The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Active comparator | Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. Receives: Other: Saline |
| Pre-eclamptic pregnant women | Experimental | In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error in the Total Volume Dispensed and Flow Rate
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.
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Principal investigator, Rebecca Richards-Kortum, William Marsh Rice University
- Investigators
- Rebecca R Kortum, PhD, Principal investigator, William Marsh Rice University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296931
- Sponsor's protocol ID
- 14-081F
- Status last verified
- Oct 2017
- First submitted
- 18 Nov 2014
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Duley L, Gulmezoglu AM, Henderson-Smart DJ, Chou D. Magnesium sulphate and other anticonvulsants for women with pre-eclampsia. Cochrane Database Syst Rev. 2010 Nov 10;2010(11):CD000025. doi: 10.1002/14651858.CD000025.pub2.
PubMed 21069663Connor SB, Quill TJ, Jacobs JR. Accuracy of drug infusion pumps under computer control. IEEE Trans Biomed Eng. 1992 Sep;39(9):980-2. doi: 10.1109/10.256432.
PubMed 1473827Skerrett E, Kommwa E, Maynard K, Juarez A, Mataya R, Richards-Kortum R, Oden ZM. Evaluation of a low-cost, low-power syringe pump to deliver magnesium sulfate intravenously to pre-eclamptic women in a Malawian referral hospital. BMC Pregnancy Childbirth. 2017 Jun 19;17(1):191. doi: 10.1186/s12884-017-1382-9.
PubMed 28629437
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory and Pilot Clinical Assessment of the Accuracy, Usability, and Function of a Low-cost, Low-power Syringe Pump in Administering Magnesium Sulfate to Pre-eclamptic Women in a Low-resource Hospital
- ClinicalTrials.gov ID
- NCT02296931
- Acronym / sponsor ID
- 14-081F
- Conditions
- Pre-eclampsia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted and relatively inexpensive treatment for these conditions, barriers to delivery via IV injection in low-resource settings pose a large obstacle to reductions in mortality. AutoSyP is a low-cost, low-powered automatic syringe pump that could overcome this barrier to the delivery of MgSO4. We propose to conduct a pilot clinical evaluation of its ability to deliver MgSO4 to women with pre-eclampsia or eclampsia in Malawi.
AutoSyP will be the subject of a 2 phase pilot clinical community trial in Malawi. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use to ensure proper procedures are followed. Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. The study will continue to Phase 2 where, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
- Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use.
- Eligible and willing participants will provide informed consent. Then, baseline demographic and relevant medical history information will be collected.
- In Phase 1, subjects will receive IV saline fluids by the Nurse. In Phase 2, the Nurse will provide loading dose of MgSO4 with the AutoSyP and research staff will monitor and record device performance and treatment specifications.
- Subsequent maintenance doses of saline or MgSO4 will be administered and observations monitored and recorded for up to 24 hours as clinically indicated.
Others may benefit from this study in the future as AutoSyP is a new delivery system is needed to break down the barriers to IV delivery of MgSO4 in low-resource settings. The results of this study will be made available to the Ministry of Health, NHSRC, COMREC, the College of Medicine Library, the Department of Paediatrics, and other partners working in neonatal and child health. Findings will be published in academic journals and conference proceedings in an effort to disseminate results to potential end-users. The research findings of this study will be critical in the evaluation of future interventions.
Detailed description
The study will recruit patients from two clinical sites (Kamuzu Central Hospital in Lilongwe, Malawi and Queen Elizabeth Central Hospital in Blantyre, Malawi) through their healthcare providers. Malawi represents an ideal location to conduct such a study as there are approximately 17,000 cases of pre-eclampsia annually. The study will include up to 40 women presenting with symptoms of pre-eclampsia.
The study will include pregnant women diagnosed with pre-eclampsia deemed to benefit from treatment with MgSO4 by healthcare providers at our participating clinical sites. Women who are eclamptic or seizing at the time of enrollment or have received MgSO4 therapy within the preceding 24 hours prior to study enrollment will be ineligible.
We will conduct an interventional study of the use of AutoSyP to deliver MgSO4 in two clinical setting in Malawi; Queen Elizabeth Central Hospital and Kamuzu Central Hospital. The study will be open and non-blinded due to ethical considerations that would arise from the denial of the experimental treatment to participants when there is no alternative form of IV MgSO4 delivery available.
All eligible and consenting women will be assigned to have treatment with AutoSyP if an AutoSyP device is available. If an AutoSyP device is not available, the participant will receive treatment for pre-eclampsia according to the standard of care at the hospital.
Pilot Clinical Evaluation Training
- Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use.
- All trained nurses will receive an identification number that will be used for recordkeeping throughout the study.
Selection of Participants
- Participants will be identified using the eligibility criteria stipulated above.
- Willing participants will provide informed consent to participate in the study.
- A participant identification number will be assigned. This number will be used for identification purposes throughout the study.
- Baseline demographic and relevant medical history information will be collected.
Treatment
- Nurse will provide loading dose with the AutoSyP. A trained Rice research assistant will observe all procedures and will correct any errors made by the nurse or answer any questions from the nurse.
- The Rice research assistant will monitor the performance of the AutoSyP, watching for any device malfunctions and notify the nurse if any are observed. The Rice research assistant will help the nurse to correct the device malfunction and treatment will continue; otherwise, an alternative AutoSyP device will be used to continue treatment. The research assistant will also use a timer to record the duration of the dose.
- The research assistant will record the following information:
- MgSO4 concentration used and syringe size
- Duration of administration
- Initial device set-up errors/questions by the nurse (e.g., user cannot operate device, user must ask for help)
- Observed malfunctions of AutoSyP
- Identification number of the nurse operating AutoSyP
- Identification number of the device
- Nurse provides maintenance doses with AutoSyP after the loading dose is complete.
- Rice research assistant repeats tasks 2-3 with reference to the maintenance dose.
- Nurse continues to provide maintenance doses for up to 24 hours as necessary.
- Rice research assistant repeats tasks 2-3 for each maintenance dose.
- Treatment will be discontinued when clinically indicted.
- Rice research assistant records the total number of doses provided and the clinical outcome of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Active comparator | Other: SalinePhase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. |
| Pre-eclamptic pregnant women | Experimental | Drug: Magnesium SulfateIn Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older
- Provide informed consent
- Agree to comply with study procedures
- Deemed medically stable by their healthcare provider, including normal range blood pressure.
- Have been clinically identified to be able to receive standard IV saline fluid
Key exclusion criteria (5 listed)
- Women with a history of heart disease of cardiac complications.
- Women with a history of complications with an IV.
- Phase 2: Pre-eclamptic Women
- Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
- Be pregnant or are <24 hours postpartum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineStandard IV Saline Fluids | Other | Healthy Adults |
| Magnesium SulfateAlso: MgSO4The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4) | Drug | Pre-eclamptic pregnant women |
Primary outcome
Error in the Total Volume Dispensed and Flow Rate
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21069663Duley L, Gulmezoglu AM, Henderson-Smart DJ, Chou D. Magnesium sulphate and other anticonvulsants for women with pre-eclampsia. Cochrane Database Syst Rev. 2010 Nov 10;2010(11):CD000025. doi: 10.1002/14651858.CD000025.pub2.
- Background: PubMed 1473827Connor SB, Quill TJ, Jacobs JR. Accuracy of drug infusion pumps under computer control. IEEE Trans Biomed Eng. 1992 Sep;39(9):980-2. doi: 10.1109/10.256432.
- Derived from this study: PubMed 28629437Skerrett E, Kommwa E, Maynard K, Juarez A, Mataya R, Richards-Kortum R, Oden ZM. Evaluation of a low-cost, low-power syringe pump to deliver magnesium sulfate intravenously to pre-eclamptic women in a Malawian referral hospital. BMC Pregnancy Childbirth. 2017 Jun 19;17(1):191. doi: 10.1186/s12884-017-1382-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca R Kortum, PhD principal investigator
William Marsh Rice University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Saline and Magnesium Sulfate in people with Pre-eclampsia, run by William Marsh Rice University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error in the Total Volume Dispensed and Flow Rate (time frame: 1 day visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296931, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.