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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: Completed NA study of Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery, sponsored by MetroHealth Medical Center.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Each fetal heart rate tracing was evaluated in 15 min increments from the completion of epidural placement and initial dose administration. ACOG Category I, II, and III was assigned to each 15 min increment.
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 |
What the finished NCT02565485 record still lists
NCT02565485 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02565485's enrollment target sits among peer trials
276 383rd of 2000 higher than 1,618 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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