Clinical trial NCT01030627: Treatment Approaches to Preeclampsia
Official title: Treatment Approaches to Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preeclampsia
Keywords: Eclampsia
Preeclampsia
Magnesium sulfate
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Daga Memorial Women's Hospital, Nagpur, India
name: Matra Sewa Sangh, Nagpur, India
name: University of Washington
First posted: 2009-12-11
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Completion of full course of treatment
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Daga Memorial Women's Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Matra Sewa Sangh
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Thomas Easterling, MD
role: PRINCIPAL_INVESTIGATOR
References: