PDF(Pubmed)
Abstract：
BACKGROUND: In 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 compliance.
OBJECTIVE: To determine the acceptability of Springfusor® pump for the administration of Magnesium Sulphate in preeclampsia and eclampsia.
METHODS: Randomized Open Label Clinical Trial.
METHODS: The study was conducted at Kawempe National Referral Hospital. Eligible women had a systolic blood pressure of ≥140mmHg and or diastolic blood pressure >90mmHg, proteinuria ≥+1, and the physician\'s decision to start on MgSO4. Four-hundred-ninety-six participants were randomized to a Springfusor® pump group (n = 248) or control (standard of care) (n = 248) administration of MgSO4. Intervention group had a loading dose (4gm of 50% MgSO4 intravenously over 20 minutes) and maintenance therapy (1gm of 50% MgSO4 intravenously per hour for 24 hours) administered using the Springfusor®. The standard of care (SOC) group received a loading dose of 4gm of 20% MgSO4 IV over 15-20 minutes, followed by 10gm of 50% MgSO4 intramuscular (5gm in each buttock) and a maintenance dose of 5gm of 50% MgSO4 was 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 the method of administration was assessed using a Likert scale (1-5; 1 and 2: acceptable and 3-5: unacceptable). Pain at the site of MgSO4 administration was assessed using a Visual Analogue Scale 1-7, (1 minimal pain and 7 worst pain). Comparisons were assessed with the Chi-square test, Mann Whitney-Wilcoxon test, and Students\' t-test.
RESULTS: Intervention arm; was more acceptable than the standard of care arm, (95.3% vs70.3%; p<0.001), had a lower median pain score, (2(CI: 2-2), vs 4(CI: 4-5) p<0.001), and fewer side effects. Maternal mortality was comparable between groups (0.8% in the intervention arm vs 1.2% in the IM arm).
BACKGROUND: Trial No PACTR201712002887266 (https://pactr.samrc.ac.za/).
OBJECTIVE: To determine the acceptability of Springfusor® pump for the administration of Magnesium Sulphate in preeclampsia and eclampsia.
METHODS: Randomized Open Label Clinical Trial.
METHODS: The study was conducted at Kawempe National Referral Hospital. Eligible women had a systolic blood pressure of ≥140mmHg and or diastolic blood pressure >90mmHg, proteinuria ≥+1, and the physician\'s decision to start on MgSO4. Four-hundred-ninety-six participants were randomized to a Springfusor® pump group (n = 248) or control (standard of care) (n = 248) administration of MgSO4. Intervention group had a loading dose (4gm of 50% MgSO4 intravenously over 20 minutes) and maintenance therapy (1gm of 50% MgSO4 intravenously per hour for 24 hours) administered using the Springfusor®. The standard of care (SOC) group received a loading dose of 4gm of 20% MgSO4 IV over 15-20 minutes, followed by 10gm of 50% MgSO4 intramuscular (5gm in each buttock) and a maintenance dose of 5gm of 50% MgSO4 was 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 the method of administration was assessed using a Likert scale (1-5; 1 and 2: acceptable and 3-5: unacceptable). Pain at the site of MgSO4 administration was assessed using a Visual Analogue Scale 1-7, (1 minimal pain and 7 worst pain). Comparisons were assessed with the Chi-square test, Mann Whitney-Wilcoxon test, and Students\' t-test.
RESULTS: Intervention arm; was more acceptable than the standard of care arm, (95.3% vs70.3%; p<0.001), had a lower median pain score, (2(CI: 2-2), vs 4(CI: 4-5) p<0.001), and fewer side effects. Maternal mortality was comparable between groups (0.8% in the intervention arm vs 1.2% in the IM arm).
BACKGROUND: Trial No PACTR201712002887266 (https://pactr.samrc.ac.za/).
摘要：
背景：在低资源设置中，用于先兆子痫的硫酸镁（MgSO4）主要通过注射入臀肌4小时，持续24小时。反复注射非常痛苦，可能导致感染，脓肿形成,降低合规性。
目的：确定Springfusor®泵在先兆子痫和子痫中施用硫酸镁的可接受性。
方法：随机开放标签临床试验。
方法：本研究在Kawempe国家转诊医院进行。符合条件的女性收缩压≥140mmHg和/或舒张压>90mmHg，蛋白尿≥+1，以及医生决定开始使用MgSO4。496名参与者被随机分配到Springfusor®泵组（n=248）或对照（标准护理）（n=248）使用MgSO4。干预组使用Springfusor®进行负荷剂量（在20分钟内静脉内4gm50％MgSO4）和维持治疗（每小时静脉内1gm50％MgSO4，持续24小时）。护理标准（SOC）组在15-20分钟内接受了4gm的20％MgSO4IV的负荷剂量，然后肌内注射10gm50％MgSO4（每个臀部5gm），每4小时IM给予5gm50％MgSO4的维持剂量，持续24小时。根据医院指南，两组均接受先兆子痫/子痫的其余护理。使用Likert量表评估给药方法的可接受性(1-5;1和2:可接受,3-5:不可接受)。使用视觉模拟量表1-7评估在MgSO4施用部位的疼痛(1个最小疼痛和7个最差疼痛)。比较采用卡方检验进行评估，MannWhitney-Wilcoxon检验,和学生t检验。
结果：干预臂；比标准护理臂更可接受，（95.3%vs70.3%；p<0.001），疼痛评分中位数较低，（2（CI：2-2），vs4（CI：4-5）p<0.001），副作用少。两组产妇死亡率相当（干预组0.8%，IM组1.2%）。
背景：试用编号PACTR201712002887266（https://pactr.Samrc.AC.za/)。
目的：确定Springfusor®泵在先兆子痫和子痫中施用硫酸镁的可接受性。
方法：随机开放标签临床试验。
方法：本研究在Kawempe国家转诊医院进行。符合条件的女性收缩压≥140mmHg和/或舒张压>90mmHg，蛋白尿≥+1，以及医生决定开始使用MgSO4。496名参与者被随机分配到Springfusor®泵组（n=248）或对照（标准护理）（n=248）使用MgSO4。干预组使用Springfusor®进行负荷剂量（在20分钟内静脉内4gm50％MgSO4）和维持治疗（每小时静脉内1gm50％MgSO4，持续24小时）。护理标准（SOC）组在15-20分钟内接受了4gm的20％MgSO4IV的负荷剂量，然后肌内注射10gm50％MgSO4（每个臀部5gm），每4小时IM给予5gm50％MgSO4的维持剂量，持续24小时。根据医院指南，两组均接受先兆子痫/子痫的其余护理。使用Likert量表评估给药方法的可接受性(1-5;1和2:可接受,3-5:不可接受)。使用视觉模拟量表1-7评估在MgSO4施用部位的疼痛(1个最小疼痛和7个最差疼痛)。比较采用卡方检验进行评估，MannWhitney-Wilcoxon检验,和学生t检验。
结果：干预臂；比标准护理臂更可接受，（95.3%vs70.3%；p<0.001），疼痛评分中位数较低，（2（CI：2-2），vs4（CI：4-5）p<0.001），副作用少。两组产妇死亡率相当（干预组0.8%，IM组1.2%）。
背景：试用编号PACTR201712002887266（https://pactr.Samrc.AC.za/)。
