Treatment Approaches to Preeclampsia

This study has been completed.
Sponsor:
Collaborators:
Daga Memorial Women's Hospital, Nagpur, India
Matra Sewa Sangh, Nagpur, India
University of Washington
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01030627
First received: December 10, 2009
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Preeclampsia
Device: Springfusor infusion pump
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Approaches to Preeclampsia

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Completion of full course of treatment [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030627

Locations
India
Daga Memorial Women's Hospital
Nagpur, Maharashtra, India
Matra Sewa Sangh
Nagpur, India
Sponsors and Collaborators
Gynuity Health Projects
Daga Memorial Women's Hospital, Nagpur, India
Matra Sewa Sangh, Nagpur, India
University of Washington
Investigators
Principal Investigator: Beverly Winikoff, MD Gynuity Health Projects
Principal Investigator: Thomas Easterling, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Beverly Winikoff, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01030627     History of Changes
Other Study ID Numbers: 4.2.2
Study First Received: December 10, 2009
Last Updated: August 10, 2011
Health Authority: India: Ministry of Health

Keywords provided by Gynuity Health Projects:
Eclampsia
Preeclampsia
Magnesium sulfate

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 23, 2014