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

NCT02296931 | Completed Phase 1 Results

• 1 other identifier: 14-081F
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

1. 1.Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use.
2. 2.Eligible and willing participants will provide informed consent. Then, baseline demographic and relevant medical history information will be collected.
3. 3.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.
4. 4.Subsequent maintenance doses of saline or MgSO4 will be administered and observations monitored and recorded for up to 24 hours as clinically indicated.

Conditions

Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day visit

Study Arms (2)

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.

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.

Drug: Magnesium Sulfate

Interventions

Saline OTHER

Standard IV Saline Fluids

Healthy Adults

Magnesium Sulfate DRUG

The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)

Also known as: MgSO4

Pre-eclamptic pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women with a history of heart disease of cardiac complications.
• Women with a history of complications with an IV.
• Phase 2: Pre-eclamptic Women
• years of age or older
• 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
• Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
• Be pregnant or are \<24 hours postpartum.

Sponsors & Collaborators

• William Marsh Rice University: lead
• University of Malawi: collaborator

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Related Publications (3)

• 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.

  PMID: 21069663 BACKGROUND

• Connor 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.

  PMID: 1473827 BACKGROUND

• Skerrett 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.

  PMID: 28629437 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Sodium Chloride; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Rebecca Richards-Kortum
• Organization: Rice 360: Institute for Global Health

rkortum@rice.edu

713-348-3823

Study Officials

• Rebecca R Kortum, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stanley C. Moore Professor, Bioengineering

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 21, 2014
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 3, 2017
• Last Updated: November 6, 2017
• Results First Posted: October 5, 2016

Record last verified: 2017-10

Locations

MA (1)