Detroit Medical Center
Detroit, Michigan, 48201, United States
NCT Number: NCT04750486
The goal of this study is to determine whether the use of sequential compression devices (lower limb compression) can reduce the rate of maternal hypotension after epidural, and therefore reduce the incidence of fetal heart tracing complications during labor.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Detroit, Michigan, 48201, United States
Maternal hypotension during epidural anesthesia in laboring patients can cause a number of problems for both mother and fetus. Despite standard anesthesia protocols designed to minimize the occurrence of hypotension during epidural placement, approximately 30% of laboring patients will still experience clinically significant hypotension. Maternal hypotension can affect placental blood flow causing fetal bradycardia and academia, as well as maternal symptoms such as dizziness, nausea, and vomiting. Therefore, there is a need for improved management of women in labor at time of epidural placement to avoid negative consequences for mother and fetus. We plan to investigate whether the use of lower limb compression devices at the time of epidural would decrease maternal hypotension.
Pregnant women who request epidural anesthesia during labor will be recruited and enrolled in this single site, randomized controlled trial. Patients will be randomized into either control or sequential compression device (SCD) groups. Following epidural, blood pressures will be measured at 1, 5, 15, 30, 45, and 60 minutes and rates of hypotension with subsequent fetal heart tracing abnormalities will be recorded.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.
Other names: Lower extremity intermittent compression devices
Time frame: Blood pressures measured at 1 minute following epidural placement.
Determined by maternal blood pressure measurements.
Time frame: Blood pressures measured at 5 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Time frame: Blood pressures measured at 15 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Time frame: Blood pressures measured at 30 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Time frame: Blood pressures measured at 45 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Time frame: Blood pressures measured at 60 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Time frame: Two hours following epidural placement.
Determination of category I, II or III fetal heart rate tracing.
Time frame: length of labor.
Vaginal or cesarean delivery ( report)
Wayne State University
Other
Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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