Randomized trial to compare acceptability of Magnesium Sulphate administration for preeclampsia and eclampsia: Springfusor pump versus standard of care

Abstract

AbstractIntroductionIn low-resource settings, magnesium sulphate (MgSO4)for preeclampsia is administered majorly through an injection into the gluteal muscles 4-hourly for 24 hours. The repeated injections are very painful and may lead to infection, abscess formation and reduced compliancy.ObjectiveTo determine the acceptability of Springfusor® pump for the administration of Magnesium Sulphate in preeclampsia and eclampsia.DesignRandomized Open Label Clinical TrialMethodStudy was conducted at Kawempe National Referral Hospital. Eligible women had systolic blood pressure of ≤40mmHg and or diastolic blood pressure >90mmHg, proteinuria ≤+1, and physician’s decision to start on MgSO4. Four-hundred-ninety-six participants were randomized to Springfusor® pump group or control (standard of care) administration of MgSO4. Intervention group had loading dose (4gm of 50% MgSO4intravenously over 20 minutes) and maintenance therapy (1gm of 50% MgSO4intravenously per hour for 24 hours) administered using the Springfusor®. The control group received a loading dose of 4gm of 20% MgSO4IV over 15-20 minutes, followed by 10gm of 50% MgSO4intramuscular (5gm in each buttock) and maintenance dose of 5gm of 50% MgSO4was administered IM every 4 hours for 24 hours. Both arms received the rest of the care for preeclampsia/eclampsia as per the hospital guidelines.Acceptability of method of administration was assessed using a Likert scale (1-5; 1 and 2: acceptable and 3-5: unacceptable). Pain at site of MgSO4administration was assessed using Visual Analogue Scale 1-7, (1 minimal pain and 7 worst pain). Comparisons were assessed with X-square and Students’ t-test.ResultsBaseline characteristics were similar in both arms. Intervention arm was; more acceptable than the standard of care arm, (94.9% vs70.3%; p<0.001), had lower pain score (2.2±1.3 vs. 4.1±1.6; p <0.001) and fewer side effects. Maternal mortality was comparable between groups (0.8% in intervention arm vs 1.2% in the IM arm).TRIAL REGISTRATIONTrial No PACTR201712002887266 (https://pactr.samrc.ac.za/)