title: Treatment approaches for preeclampsia in low-resource settings: A randomized trial of the Springfusor pump for delivery of magnesium sulfate.
abstract: OBJECTIVE
  To test the safety, efficacy, and acceptability of a simple, mechanically flow-controlled pump (Springfusor®) for the delivery of magnesium sulfate for the treatment of preeclampsia.
  
  
  METHODS
  Eligible women (n=300) had blood pressure ⩾140/100mmHg, and proteinuria ⩾1+ (30mgdL); the clinic team determined that they were likely to benefit from magnesium sulfate. Women were randomized to 24h of magnesium sulfate by either IV administered by the Springfusor® pump (n=147) or standard hospital practice - IV loading dose administered manually followed by maintenance therapy using an IM route of administration (n=153).
  
  
  METHODS
  Our primary outcome of interest was the safety and efficacy of the Springfusor pump including the side and adverse effects experienced during drug administration. Data on side effects, patient acceptability, delivery complications, and maternal and neonatal outcomes were collected.
  
  
  RESULTS
  Fewer women stopped treatment due to side effects, toxicity, oliguria or renal failure, or women's request in the Springfusor arm (4% or 6 of 147 women) compared to the Standard of Care arm (6.5% or 10 of 153 women). Women in the Springfusor arm reported significantly less nausea, headache, and pain than women in the Standard of Care arm. Almost all women (97%) in the Springfusor arm reported their pain level as 'acceptable' or 'very acceptable' compared to only 30% of women given the Standard of Care.
  
  
  CONCLUSIONS
  The Springfusor pump may offer an alternative to intramuscular administration of magnesium sulfate where electronic pumps are not available.
authors.affiliation: Government Medical College, Nagpur, India.
authors.forename: Shuchita
authors.initials: S
authors.lastname: Mundle
authors.affiliation: Christian Medical College, Vellore, India.
authors.forename: Annie
authors.initials: A
authors.lastname: Regi
authors.affiliation: University of Washington, Seattle, Washington, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Easterling
authors.affiliation: Christian Medical College, Vellore, India.
authors.forename: Bivas
authors.initials: B
authors.lastname: Biswas
authors.affiliation: Gynuity Health Projects, New York, NY, USA. Electronic address: hbracken@gynuity.org.
authors.forename: Hillary
authors.initials: H
authors.lastname: Bracken
authors.affiliation: Daga Memorial Women's Hospital, Nagpur, India.
authors.forename: Vaishali
authors.initials: V
authors.lastname: Khedekar
authors.affiliation: Matra Sewa Sangh, Nagpur, India.
authors.forename: D
authors.initials: D
authors.lastname: Ratna Shekhavat
authors.affiliation: Gynuity Health Projects, New York, NY, USA.
authors.forename: Jill
authors.initials: J
authors.lastname: Durocher
authors.affiliation: Gynuity Health Projects, New York, NY, USA.
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
keywords: Magnesium sulfate; Preeclampsia