An observational study in Maternal Hypotension, Labor Epidural Analgesia and Fetal Heart Rate Abnormalities, sponsored by The Chaim Sheba Medical Center. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by The Chaim Sheba Medical Center · Observational
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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 480 is above the median of 90 across 265 observational studies indexed under Hypotension.
Browse Hypotension studies →The Chaim Sheba Medical Center is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Laboring adults who receive epidural analgesia for pain relief at the labor and delivery unit of Sheba Medical Center, a large tertiary hospital in Israel. Participants represent people giving birth at term who choose epidural analgesia as part of their routine clinical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This cohort includes adults in labor at Sheba Medical Center who choose to receive epidural analgesia for pain relief. All participants receive standard clinical care. Researchers will observe maternal blood pressure and fetal heart rate changes during the first 30 minutes after the epidural.
Other: Epidural Analgesia (Standard Clinical Care)
Participants receive epidural analgesia for labor pain relief as part of routine clinical care at Sheba Medical Center. The epidural involves placement of an epidural catheter, a test dose, and a loading dose of local anesthetic according to hospital protocol. The study does not change how the epidural is performed. Researchers only observe maternal blood pressure and fetal heart rate after epidural placement.
Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg
Hypotension after epidural placement
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with any MAP (mean arterial pressure) < 60, 55 mmHg
Hypotension after epidural placement
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with any SBP (systolic blood pressure) < 90, 85, 80 mmHg
Hypotension after epidural placement
Time frame: First 30 minutes after epidural placement
Incidence of postepidural hypotension defined as ≥20% MAP (mean arterial pressure) drop
Hypotension after epidural placement
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with ≥20% SBP (systolic blood pressure) drop
Hypotension after epidural placement
Time frame: First 30 minutes after epidural placement
Time-to-treatment of Hypotension (minutes)
The time interval between epidural placement and the treatment of hypotension by clinical staff
Time frame: First 30 minutes after epidural placement
Area under a MAP of 65, 60, 55 mmHg [mmHg x min]
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with symptoms due to hypotension
Weakness, lightheadedness, fainting, dizziness, nausea, vomiting
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with NRFHR (Non-reassuring fetal heart rate)
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients who received fluid bolus
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients who received vasopressor
Phenylephrine, ephedrine
Time frame: 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)
Time frame: First 30 minutes after epidural placement
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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The Chaim Sheba Medical Center