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Treatment Approaches to Preeclampsia

NCT01030627 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2011-08-11

No results posted yet for this study

Summary

This pilot study will document the efficacy and acceptability of administration of magnesium sulfate with the Springfusor pump for patients and staff at two sites where treatment or preeclampsia with magnesium sulfate is limited or not available. Currently, both sites refer patients to tertiary care facilities for further treatment.

Conditions

Interventions

DEVICE

Springfusor infusion pump

Women will receive a loading dose and maintenance therapy using an IV infusion administered by the Springfusor® pump. Women will receive a 8 mL loading dose containing 4g magnesium sulfate heptahydrate (MgSO4\*7H2O) 50% solution, which is approximately 2 mmoL magnesium/mL. The loading dose of 8mL with 4 g MgSO4 will be administered using the Springfusor® pump. The administration of the loading dose will be immediately followed by a maintenance infusion. The maintenance dose of 4 g (8 cc, 50% MgSO4) will be administered with the Springfusor® pump continuously over four hours. The pump will be started immediately after the initial bolus and the 4g dose repeated (and syringe replaced) every four hours. Maintenance therapy will be administered for at least 24h. Treatment will be discontinued when clinically indicated. Drug administration will be initiated at the sites and, when necessary, the patient will be transferred, with the Springfusor pump in situ, to the local referral site.

Sponsors & Collaborators

  • Daga Memorial Women's Hospital, Nagpur, India

    collaborator OTHER

  • Matra Sewa Sangh, Nagpur, India

    collaborator UNKNOWN

  • University of Washington

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD · Gynuity Health Projects

  • Thomas Easterling, MD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • India

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 NCT01030627 on ClinicalTrials.gov