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Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia

NCT03549767 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2018-06-08

No results posted yet for this study

Summary

Magnesium Sulphate is the drug of choice for prevention and treatment of seizures in preeclampsia and eclampsia. It is administered parenterally by intravenous (IV) and or intramuscular (IM) routes. The IM regimen requires repeated painful injections which may be a barrier to optimal utilization whereby, there is frequent omission of some doses or increased interval between maintenance doses and low patient acceptability of magnesium. The study plans to assess the acceptability and safety of Springfusor device in the administration of magnesium sulphate in preeclampsia and eclampsia.

Conditions

  • Preeclampsia and Eclampsia

Interventions

DEVICE

Springfusor

Springfusor for administration of magnesium sulphate

PROCEDURE

Standard of care

Pritchard regimen. Magnesium sulphate is administered using hospital practice

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Sam Ononge, PhD · Makerere University College of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2019-04-30
Completion
2019-08-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549767 on ClinicalTrials.gov