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NCT02565485 · ClinicalTrials.gov registry record · NA
Pulse Pressure and Post-epidural Fetal Heart Rate Changes
A NA study of Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 276
- Enrollment target
- 1
- Study location
NCT02565485 is a NA study of Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery that has completed, run by MetroHealth Medical Center. The registered enrollment target is 276 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02565485, a NA study of Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 276 participants
- Enrollment target
- 1
- Study location
Study Summary
Epidural anesthesia, the most common method of pain control in labor, can contribute to alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the administration of an IV fluid bolus ("preload") is standard prior to epidural placement. However, the optimal volume of preload is unknown and no clinical trials have evaluated a risk-factor based approach to dosing. Studies in the critical care, trauma, and obstetric literature have suggested that a narrow pulse pressure (difference between systolic and diastolic blood pressures) is a marker of reduced intravascular volume status and may identify women at a higher risk for new onset fetal heart rate changes after epidural placement. Therefore, the purpose of this study is to assess if an increased IV fluid preload bolus among women with a narrow pulse pressure reduces the risk of new onset fetal heart rate changes after epidural placement.
Conditions Studied
Interventions
- DRUG Lactated Ringer's
Study Locations (1)
Ohio
- MetroHealth Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2015-09-01 |
| Est. Completion | 2016-11-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02565485
The ClinicalTrials.gov registry entry for NCT02565485 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery appearing as the primary indexed condition, and to 1 intervention - of which Lactated Ringer's is the first listed.
NCT02565485 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02565485 about?
NCT02565485 is a clinical study titled "Pulse Pressure and Post-epidural Fetal Heart Rate Changes". Epidural anesthesia, the most common method of pain control in labor, can contribute to alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the administration of an IV fluid bolus ("preload") is standard prior to epidural placement. However, the optimal volume of pre...
What is the current status of trial NCT02565485?
This trial is currently completed. It is a NA study. The enrollment target is 276 participants. The study started on 2015-09-01. Estimated completion is 2016-11-01.
What conditions does trial NCT02565485 study?
This clinical trial studies the following conditions: Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery.
What interventions are being tested in trial NCT02565485?
The interventions under investigation include: Lactated Ringer's (DRUG).
Who is sponsoring clinical trial NCT02565485?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02565485 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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