Labor PainNCT04750486
Lower Limb Compression Prevents Hypotension After Epidural in Labor
A study testing Sequential compression devices in people with Labor Pain and Maternal Hypotension, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Maternal Hypotension
- What is being tested?
- Sequential compression devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Labor Pain, Maternal Hypotension
- Being tested
- Sequential compression devices
- Keywords
- Epidural anesthesia, Lower extremity compression
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential compression devicesDevice
Also called Lower extremity intermittent compression devices
Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention, the patient will be provided routine care at time of epidural placement without use of sequential compression devices. |
| Lower Extremity Compression | Experimental | Patients will have sequential compression devices prior to epidural placement, and maintained for at least one hour following procedure. Receives: Device: Sequential compression devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal hypotension
Determined by maternal blood pressure measurements.
Measured: Blood pressures measured at 1 minute following epidural placement.
Maternal hypotension
Determined by maternal blood pressure measurements.
Measured: Blood pressures measured at 5 minutes following epidural placement.
Maternal hypotension
Determined by maternal blood pressure measurements.
Measured: Blood pressures measured at 15 minutes following epidural placement.
Maternal hypotension
Determined by maternal blood pressure measurements.
Measured: Blood pressures measured at 30 minutes following epidural placement.
Maternal hypotension
Determined by maternal blood pressure measurements.
Measured: Blood pressures measured at 45 minutes following epidural placement.
Maternal hypotension
Determined by maternal blood pressure measurements.
Measured: Blood pressures measured at 60 minutes following epidural placement.
Secondary outcomes (2)
Fetal heart rate tracing category
Determination of category I, II or III fetal heart rate tracing.
Measured: Two hours following epidural placement.
Delivery method
Vaginal or cesarean delivery ( report)
Measured: length of labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start5 Feb 2021
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of patients to either control or study groups.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Mroue, MD, Wayne State University
- Investigators
- Jeffrey Johnson, MD, Study director, Detroit Medical Center/Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750486
- Sponsor's protocol ID
- IRB# 20-07-2555
- Status last verified
- Aug 2023
- First submitted
- 29 Jan 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 3674479Goetzl 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.
PubMed 12100826Corke 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.
PubMed 7091625American 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.
PubMed 17413923
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04750486
- Acronym / sponsor ID
- IRB# 20-07-2555
- Conditions
- Labor Pain, Maternal Hypotension
- Keywords
- Epidural anesthesia, Lower extremity compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization of patients to either control or study groups.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention, the patient will be provided routine care at time of epidural placement without use of sequential compression devices. |
| Lower Extremity Compression | Experimental | Device: Sequential compression devicesPatients will have sequential compression devices prior to epidural placement, and maintained for at least one hour following procedure. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential compression devicesAlso: Lower extremity intermittent compression devicesTwo lower limb intermittent compression devices to be placed on the mid-calf of each leg. | Device | Lower Extremity Compression |
Primary outcome
Maternal hypotension
Time frame: Blood pressures measured at 1 minute following epidural placement.
Determined by maternal blood pressure measurements.
Maternal hypotension
Time frame: Blood pressures measured at 5 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Maternal hypotension
Time frame: Blood pressures measured at 15 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Maternal hypotension
Time frame: Blood pressures measured at 30 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Maternal hypotension
Time frame: Blood pressures measured at 45 minutes following epidural placement.
Determined by maternal blood pressure measurements.
Maternal hypotension
Time frame: Blood pressures measured at 60 minutes following epidural placement.
Determined by maternal blood pressure measurements.
2 secondary outcomes
Fetal heart rate tracing category
Time frame: Two hours following epidural placement.
Delivery method
Time frame: length of labor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 3674479Brizgys 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.
- Background: PubMed 12100826Goetzl 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.
- Background: PubMed 7091625Corke 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.
- Background: PubMed 17413923American 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Johnson, MD study director
Detroit Medical Center/Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential compression devices in people with Labor Pain and Maternal Hypotension, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal hypotension (time frame: Blood pressures measured at 1 minute following epidural placement.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750486, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.