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. DESIGN: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). MAIN OUTCOME MEASURES: 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. CONCLUSION: The Springfusor pump may offer an alternative to intramuscular administration of magnesium sulfate where electronic pumps are not available.
RCT Entities:
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. DESIGN: 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). MAIN OUTCOME MEASURES: 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. CONCLUSION: The Springfusor pump may offer an alternative to intramuscular administration of magnesium sulfate where electronic pumps are not available.
Authors: Emily Shepherd; Rehana A Salam; Deepak Manhas; Anne Synnes; Philippa Middleton; Maria Makrides; Caroline A Crowther Journal: PLoS Med Date: 2019-12-06 Impact factor: 11.069
Authors: Elizabeth Abu-Haydar; David Katuntu; James Bauer; Alec Wollen; Mike Eisenstein; Jill Sherman-Konkle; Anthony Roche; Michael Ruffo Journal: Med Devices (Auckl) Date: 2021-06-24
Authors: Jeffrey Michael Smith; Richard F Lowe; Judith Fullerton; Sheena M Currie; Laura Harris; Erica Felker-Kantor Journal: BMC Pregnancy Childbirth Date: 2013-02-05 Impact factor: 3.007