Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Labor Pain
  • Maternal Hypotension
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomization of patients to either control or study groups.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Description

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 experie...

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.

Tracking Information

NCT #
NCT04750486
Collaborators
Not Provided
Investigators
Study Director: Jeffrey Johnson, MD Detroit Medical Center/Wayne State University