Treatment Approaches to Preeclampsia
1 other identifier
interventional
85
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 11, 2011
August 1, 2011
6 months
December 10, 2009
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completion of full course of treatment
24 hours
Interventions
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.
Eligibility Criteria
You may qualify if:
- Exhibit systolic blood pressure \> 140mm Hg OR a diastolic pressure \> 100 mm Hg
- Exhibit proteinuria \> 1+
- Have not given birth, or be 24h or less postpartum
- Exhibit urine output \>100 ml or more during the previous 4h or greater than 25 mL/h
- Agree to comply with study procedures
- Be \> 18 years of age
- Give informed consent for study participation
You may not qualify if:
- Eclamptic or seizing at the time of enrollment
- Received magnesium sulfate therapy 24h prior to study enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynuity Health Projectslead
- Daga Memorial Women's Hospital, Nagpur, Indiacollaborator
- Matra Sewa Sangh, Nagpur, Indiacollaborator
- University of Washingtoncollaborator
Study Sites (2)
Daga Memorial Women's Hospital
Nagpur, Maharashtra, India
Matra Sewa Sangh
Nagpur, India
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beverly Winikoff, MD
Gynuity Health Projects
- PRINCIPAL INVESTIGATOR
Thomas Easterling, MD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 11, 2009
Study Start
October 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 11, 2011
Record last verified: 2011-08