- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030627
Treatment Approaches to Preeclampsia
Study Overview
Detailed Description
Women diagnosed with preeclampsia that the clinic care team deem would benefit from treatment with magnesium sulfate will be given the option of participating in the study. Those who choose to take part in the study and meet study inclusion and exclusion criteria will receive full information about the study and be required to give their written or signed informed consent.
Women agreeing to participate in the study 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. Clinical monitoring will occur once every hour during the treatment period. Clinical monitoring will occur throughout the treatment, with reflexes, urine output and respiration to be checked at least every hour (or, if more frequent, as per standard practice at the study site). The pump will be checked at each monitoring visit. Prior to discharge from the study, patients will be asked to assess their opinions about the acceptability and ease of use of the mode of administration. All requests or inquiries about termination of treatment will be recorded.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Nagpur, India
- Matra Sewa Sangh
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Maharashtra
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Nagpur, Maharashtra, India
- Daga Memorial Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Eclamptic or seizing at the time of enrollment
- Received magnesium sulfate therapy 24h prior to study enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Completion of full course of treatment
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Beverly Winikoff, MD, Gynuity Health Projects
- Principal Investigator: Thomas Easterling, MD, University of Washington
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4.2.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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