Labor Pain, Maternal Hypotension
Conditions
Keywords
Epidural anesthesia, Lower extremity compression
Brief summary
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.
Detailed 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 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.
Interventions
Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.
Sponsors
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomization of patients to either control or study groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with pregnancy at term (greater than or equal to 37 weeks 0 days gestation) * Singleton gestation * In labor (spontaneous or induced) * Requested epidural for pain management
Exclusion criteria
* Any diagnosis of hypertension or cardiovascular disease * Any contraindications to lower extremity compression including deep venous thrombosis in past 6 months, infected leg wound, or deformity of lower extremity * Any contraindications to epidural placement including severe thrombocytopenia and spinal deformity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal hypotension | Blood pressures measured at 1 minute following epidural placement. | Determined by maternal blood pressure measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal heart rate tracing category | Two hours following epidural placement. | Determination of category I, II or III fetal heart rate tracing. |
| Delivery method | length of labor. | Vaginal or cesarean delivery ( report) |
Countries
United States
Outcome results
None listed