Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04750486
Other study ID # IRB# 20-07-2555
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Completed NCT03539562 - Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Withdrawn NCT04662450 - Evaluation and Management of Parturients' Pain Intensity N/A
Completed NCT02885350 - Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour Phase 4
Completed NCT02550262 - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor N/A
Completed NCT01598506 - Intrathecal Hydromorphone for Labor Analgesia Phase 2
Withdrawn NCT01636999 - Comparing Sedara to Butorphanol in Early Labor N/A
Completed NCT00987441 - Epidural Labor Analgesia and Infant Neurobehavior N/A
Completed NCT00755092 - Effect of Doula in Nulliparas and Multiparas N/A
Terminated NCT00787176 - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes N/A
Recruiting NCT06036797 - Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia Phase 2
Completed NCT05512065 - Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women N/A
Completed NCT05327088 - Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia Phase 2
Completed NCT03103100 - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation Phase 3
Recruiting NCT03623256 - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia Phase 4
Active, not recruiting NCT02271100 - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique N/A
Completed NCT02926469 - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study N/A
Completed NCT03712735 - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women Phase 4
Not yet recruiting NCT05565274 - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients N/A
Recruiting NCT01708668 - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia N/A
Recruiting NCT02575677 - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety