Incidence and Clinical Significance of Maternal Hypotension After Labor Epidural Analgesia and Its Effects on Fetal Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 主要终点
- Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg
研究概览
简要总结
The goal of this study is to learn how often blood pressure drops after an epidural for labor and how these drops may affect the parent and the baby. The study focuses on adults who give birth at term and choose to receive an epidural for pain relief.
The main questions the study aims to answer are:
How often does maternal blood pressure fall within 30 minutes after the epidural? When blood pressure falls, how often do participants need treatments such as fluids or medicines that raise blood pressure? Do changes in the baby's heart rate happen during this time, and do they need treatment? Are certain parent or labor factors linked to a higher chance of blood pressure drops? How often does an urgent cesarean delivery happen because of maternal low blood pressure or concerning fetal heart rate changes soon after the epidural?
Participants will not be asked to do anything different from usual care. Researchers will:
Review routine vital signs recorded before and after the epidural Review treatments given, such as IV fluids or blood-pressure-raising medicines Review the baby's heart-rate monitoring Record delivery information, including whether an urgent cesarean was needed This study does not change clinical care in any way. It uses information already collected during standard labor and delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •37 weeks pregnant or more (term pregnancy)
- •in labor and choose to receive an epidural for pain relief
- •giving birth at Sheba Medical Center
排除标准
- •patients with a heart condition that requires special blood pressure management
- •medical conditions that prevent safe monitoring of blood pressure
- •missing or incomplete medical record data needed for the study
- •patient who do not receive an epidural during labor
结局指标
主要结局
Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg
时间窗: First 30 minutes after epidural placement
Hypotension after epidural placement
次要结局
- Incidence of postepidural hypotension defined as ≥20% MAP (mean arterial pressure) drop(First 30 minutes after epidural placement)
- Absolute and relative number of patients with ≥20% SBP (systolic blood pressure) drop(First 30 minutes after epidural placement)
- Absolute and relative number of patients with any MAP (mean arterial pressure) < 60, 55 mmHg(First 30 minutes after epidural placement)
- Absolute and relative number of patients with any SBP (systolic blood pressure) < 90, 85, 80 mmHg(First 30 minutes after epidural placement)
- Time-to-treatment of Hypotension (minutes)(First 30 minutes after epidural placement)
- Area under a MAP of 65, 60, 55 mmHg [mmHg x min](First 30 minutes after epidural placement)
- Absolute and relative number of patients with symptoms due to hypotension(First 30 minutes after epidural placement)
- Absolute and relative number of patients with NRFHR (Non-reassuring fetal heart rate)(First 30 minutes after epidural placement)
- Absolute and relative number of patients who received fluid bolus(First 30 minutes after epidural placement)
- Absolute and relative number of patients who received vasopressor(First 30 minutes after epidural placement)
- Absolute and relative numbers of patients who underwent urgent Cesarean section (Category 1 or 2 urgency) due to hypotension or NRFHR (non-reassuring fetal heart rate)(First 30 minutes after epidural placement)
研究者
Maxim Glebov
Staff Anesthesiologist in the Department of Anesthesiology
The Chaim Sheba Medical Center