Lower Limb Compression Prevents Hypotension After Epidural in Labor

Labor Pain Clinical Trial

Official title:

Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750486
• Other study ID #: IRB# 20-07-2555
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: August 2023
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Labor Pain
• Maternal Hypotension

Intervention

Device:
• Sequential compression devices
Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.

Locations

Country	Name	City	State
United States	Detroit Medical Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal hypotension	Determined by maternal blood pressure measurements.	Blood pressures measured at 1 minute following epidural placement.
Primary	Maternal hypotension	Determined by maternal blood pressure measurements.	Blood pressures measured at 5 minutes following epidural placement.
Primary	Maternal hypotension	Determined by maternal blood pressure measurements.	Blood pressures measured at 15 minutes following epidural placement.
Primary	Maternal hypotension	Determined by maternal blood pressure measurements.	Blood pressures measured at 30 minutes following epidural placement.
Primary	Maternal hypotension	Determined by maternal blood pressure measurements.	Blood pressures measured at 45 minutes following epidural placement.
Primary	Maternal hypotension	Determined by maternal blood pressure measurements.	Blood pressures measured at 60 minutes following epidural placement.
Secondary	Fetal heart rate tracing category	Determination of category I, II or III fetal heart rate tracing.	Two hours following epidural placement.
Secondary	Delivery method	Vaginal or cesarean delivery ( report)	length of labor.