Pulse Pressure and Post-epidural Fetal Heart Rate Changes
Completed · Not applicable
Conditions studied: Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery
In brief
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.
Key facts
- Study ID
- NCT02565485
- Run by
- MetroHealth Medical Center
- People needed
- 276
- Starts
- 2015-09-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2018-07-09
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Singleton pregnancy with gestational age ≥ 35 weeks
- Admission for delivery
- Age 18 or older
- Desires neuraxial analgesia in labor
- No exclusion criteria
- Maternal pulse pressure < 45 mmHg on admission (verified by repeat blood pressure)
- Category 1 FHT on admission/prior to epidural placement
- Epidural placement within 6 hours of admission to Labor and Delivery
You may not qualify if…
- Multiple gestation
- Intrauterine growth restriction
- Hypertensive disorders (gestational hypertension, chronic hypertension, and preeclampsia/eclampsia)
- Gestational or pregestational diabetes mellitus
- Substance abuse
- Intrauterine fetal demise
- Congenital or chromosomal fetal abnormalities
- Category II or III FHR tracing on admission to L\&D (pre-epidural)
- Contraindication to neuraxial aesthesia (e.g. thrombocytopenia)
- Maternal cardiomyopathy, congenital heart disease, active pulmonary edema or any other underlying maternal cardiopulmonary condition that increases the risk of pulmonary edema
- Maternal renal insufficiency (serum creatinine > 1.0)
- Maternal hypotension (as defined in secondary outcomes below) prior to epidural placement
Where it is running
- MetroHealth Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.