Clinical trial NCT04750486: Lower Limb Compression Prevents Hypotension After Epidural in Labor
Official title: Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Maternal Hypotension
Keywords: Epidural anesthesia
Lower extremity compression
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of patients to either control or study groups.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal hypotension
timeFrame: Blood pressures measured at 1 minute following epidural placement.
measure: Maternal hypotension
timeFrame: Blood pressures measured at 5 minutes following epidural placement.
measure: Maternal hypotension
timeFrame: Blood pressures measured at 15 minutes following epidural placement.
measure: Maternal hypotension
timeFrame: Blood pressures measured at 30 minutes following epidural placement.
measure: Maternal hypotension
timeFrame: Blood pressures measured at 45 minutes following epidural placement.
measure: Maternal hypotension
timeFrame: Blood pressures measured at 60 minutes following epidural placement.
Secondary outcomes:
measure: Fetal heart rate tracing category
timeFrame: Two hours following epidural placement.
measure: Delivery method
timeFrame: length of labor.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
Study officials:
affiliation: Detroit Medical Center/Wayne State University
name: Jeffrey Johnson, MD
role: STUDY_DIRECTOR
References:
citation: Brizgys RV, Dailey PA, Shnider SM, Kotelko DM, Levinson G. The incidence and neonatal effects of maternal hypotension during epidural anesthesia for cesarean section. Anesthesiology. 1987 Nov;67(5):782-6. doi: 10.1097/00000542-198711000-00025. No abstract available.
citation: Goetzl LM; ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists Number 36, July 2002. Obstetric analgesia and anesthesia. Obstet Gynecol. 2002 Jul;100(1):177-91. doi: 10.1016/s0029-7844(02)02156-7.
citation: Corke BC, Datta S, Ostheimer GW, Weiss JB, Alper MH. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anaesthesia. 1982 Jun;37(6):658-62. doi: 10.1111/j.1365-2044.1982.tb01278.x.
citation: American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.