Role of prophylactic intravenous calcium in prevention of post-spinal hypotension among women with preeclampsia undergoing caesarean delivery: a placebo controlled randomized clinical trial: Randomized clinical trial of calcium vs placebo for prevention of post-spinal hypotension.

IF 3.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY American Journal of Obstetrics & Gynecology Mfm Pub Date : 2024-11-11 DOI:10.1016/j.ajogmf.2024.101541
Navin Kumar Yadav, Suman Lata, Nivedita Jha, Deepak Chakravarthy, Ajay Kumar Jha
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Abstract

Background: Preeclamptic women, in addition to traditional anti-hypertensive medications, often receive magnesium supplementation and are at increased risk of post-spinal hypotension Post-spinal hypotension increases the risk of fetomaternal morbidity. Calcium is a physiological antagonist of magnesium in vascular smooth muscle. Therefore, the study hypothesized that calcium is better suited for preserving systemic vascular resistance and preventing post-spinal hypotension during cesarean delivery.

Objectives: The study aimed to evaluate the effect of prophylactic calcium administration on post-spinal hypotension in preeclamptic women receiving magnesium supplementation.

Methods: This prospective, randomized, placebo-controlled, double-blinded, two-arm parallel trial was conducted in preeclamptic women receiving magnesium sulfate supplementation undergoing cesarean delivery. The women were randomized to receive intravenous calcium or a placebo (normal saline) before spinal anesthesia. The study drug (calcium gluconate 500 mg or normal saline) was administered over 15 minutes and ended immediately before spinal anesthesia. The primary outcome measure was the incidence of post-spinal hypotension, and secondary outcome measures were postpartum blood loss and maternal and neonatal outcomes.

Results: 100 women (50 each calcium and placebo arm) completed the study. The baseline demographic variables, mean blood pressure and heart rate were comparable. The incidence of post-spinal hypotension was significantly lower in the calcium arm compared to the placebo arm {(32% vs 60%; Relative risk (95% CI); 1.87 (1.18-2.97); p=0.007)}. The mean phenylephrine requirement (5.60±14.59 vs 14.80 ±22.42 mcg; p=0.01) and mephentermine requirement (3.30 ±5.11 mg vs 5.82 ±4.97 mg; p=0.008) was significantly lower in the calcium group. Furthermore, the calcium group's mean postpartum blood loss was significantly lower (406.90 ±94.34 vs 472.20±122.49 ml, p= 0.004). However, the Neonatal Intensive Care Unit admission rate, Apgar score, umbilical artery PH, and maternal serum calcium were comparable.

Conclusion: Prophylactic calcium infusion significantly reduces the incidence of post-spinal hypotension during cesarean delivery in preeclamptic women receiving magnesium supplementation. Furthermore, the effect of prophylactic calcium in decreasing postpartum blood loss is encouraging. However, large trials are required to validate the findings of this study.

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预防性静脉注射钙剂在预防剖腹产子痫前期妇女椎管后低血压中的作用:安慰剂对照随机临床试验:预防椎管后低血压的钙剂与安慰剂随机临床试验。
背景:先兆子痫妇女除了服用传统的抗高血压药物外,通常还需要补充镁,这增加了椎管后低血压的风险。钙在血管平滑肌中是镁的生理性拮抗剂。因此,研究假设钙更适合在剖宫产过程中保护全身血管阻力和预防椎管后低血压:该研究旨在评估预防性服用钙剂对接受镁补充剂的先兆子痫产妇椎管后低血压的影响:这项前瞻性、随机、安慰剂对照、双盲、双臂平行试验在接受硫酸镁补充剂的子痫前期产妇中进行。产妇在脊髓麻醉前随机接受静脉注射钙剂或安慰剂(生理盐水)。研究药物(葡萄糖酸钙 500 毫克或生理盐水)的给药时间为 15 分钟,并在脊髓麻醉前立即结束。主要结果指标是脊柱麻醉后低血压的发生率,次要结果指标是产后失血量以及产妇和新生儿的预后:100名产妇(钙剂组和安慰剂组各50名)完成了研究。基线人口统计学变量、平均血压和心率具有可比性。与安慰剂组相比,钙剂组椎管后低血压的发生率明显降低{(32% vs 60%;相对风险(95% CI);1.87 (1.18-2.97); p=0.007)}。钙剂组的平均苯肾上腺素需求量(5.60±14.59 vs 14.80±22.42 mcg;p=0.01)和甲芬吗啉需求量(3.30±5.11 mg vs 5.82±4.97 mg;p=0.008)显著低于安慰剂组。此外,钙剂组的产后平均失血量也明显较低(406.90 ±94.34 vs 472.20 ±122.49 ml,p= 0.004)。然而,新生儿重症监护室入院率、Apgar评分、脐动脉PH值和产妇血清钙却相当:结论:预防性输注钙剂可显著降低接受镁补充剂的先兆子痫产妇在剖宫产过程中椎管后低血压的发生率。此外,预防性钙剂在减少产后失血方面的效果也令人鼓舞。然而,要验证这项研究的结果,还需要进行大规模的试验。
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来源期刊
CiteScore
7.40
自引率
3.20%
发文量
254
审稿时长
40 days
期刊介绍: The American Journal of Obstetrics and Gynecology (AJOG) is a highly esteemed publication with two companion titles. One of these is the American Journal of Obstetrics and Gynecology Maternal-Fetal Medicine (AJOG MFM), which is dedicated to the latest research in the field of maternal-fetal medicine, specifically concerning high-risk pregnancies. The journal encompasses a wide range of topics, including: Maternal Complications: It addresses significant studies that have the potential to change clinical practice regarding complications faced by pregnant women. Fetal Complications: The journal covers prenatal diagnosis, ultrasound, and genetic issues related to the fetus, providing insights into the management and care of fetal health. Prenatal Care: It discusses the best practices in prenatal care to ensure the health and well-being of both the mother and the unborn child. Intrapartum Care: It provides guidance on the care provided during the childbirth process, which is critical for the safety of both mother and baby. Postpartum Issues: The journal also tackles issues that arise after childbirth, focusing on the postpartum period and its implications for maternal health. AJOG MFM serves as a reliable forum for peer-reviewed research, with a preference for randomized trials and meta-analyses. The goal is to equip researchers and clinicians with the most current information and evidence-based strategies to effectively manage high-risk pregnancies and to provide the best possible care for mothers and their unborn children.
期刊最新文献
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