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Completed

NCT Number: NCT04750486

Lower Limb Compression Prevents Hypotension After Epidural in Labor

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Detroit Medical Center

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sequential compression devices

Device

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

Other names: Lower extremity intermittent compression devices

Primary outcomes

  1. Maternal hypotension

    Time frame: Blood pressures measured at 1 minute following epidural placement.

    Determined by maternal blood pressure measurements.

  2. Maternal hypotension

    Time frame: Blood pressures measured at 5 minutes following epidural placement.

    Determined by maternal blood pressure measurements.

  3. Maternal hypotension

    Time frame: Blood pressures measured at 15 minutes following epidural placement.

    Determined by maternal blood pressure measurements.

  4. Maternal hypotension

    Time frame: Blood pressures measured at 30 minutes following epidural placement.

    Determined by maternal blood pressure measurements.

  5. Maternal hypotension

    Time frame: Blood pressures measured at 45 minutes following epidural placement.

    Determined by maternal blood pressure measurements.

  6. Maternal hypotension

    Time frame: Blood pressures measured at 60 minutes following epidural placement.

    Determined by maternal blood pressure measurements.

Secondary outcomes

  1. Fetal heart rate tracing category

    Time frame: Two hours following epidural placement.

    Determination of category I, II or III fetal heart rate tracing.

  2. Delivery method

    Time frame: length of labor.

    Vaginal or cesarean delivery ( report)

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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