HypotensionNCT05250960
Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor
A study testing SCD in people with Hypotension and Labor Complication, run by TriHealth Inc. at 1 site in United States.
Trial summary
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Labor Complication
- What is being tested?
- SCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 27 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laboring at Bethesda North Hospital Labor \& Delivery Unit
- Will receive epidural analgesia
- 37+ weeks gestation
- Singleton pregnancy
- Category 1 tracings only before epidural placement
Who cannot join
- Under 18 years old
- Does not speak English
- Unable to consent to involvement in the research study
- Diagnosed with fetal demise
- Diagnosis of pre-existing hypertension
- Diagnosis of gestational hypertension
Show all 13Show fewer
- Diagnosis of pre-eclampsia
- Diagnosis of diabetes
- Breech presentation
- Contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.)
- Contraindications to receiving 1L of LR
- Blood pressure on admission systolic blood pressure (SBP)>160 or diastolic blood pressure (DBP)>110
- Fetal heart rate abnormalities before epidural
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of Pre-epidural Placement of Sequential Compression Devices (SCD) to Prevent Hypotension
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:
- Arm 1: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
- Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Read the detailed description
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:
- Arm 1: Patient will receive 1liter (L) of lactated ringers (LR) and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
- Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs Outcome variables include occurrence of maternal hypotension or Category II fetal tracings in the first hour after epidural placement.
- Conditions
- Hypotension, Labor Complication
- Being tested
- SCD
- Medical subject headings
- Hypotension, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCDDevice
Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
| Study group | Role | What they receive |
|---|---|---|
| Intervention - SCD arm | Experimental | Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement Receives: Device: SCD |
| Control - no SCD arm | No intervention | Patient will receive 1L of LR during and after epidural placement with no use of SCDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)
Measured: 1 hour
Category II Tracings
Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not
Category II tracings - The classification of Category II tracings includes the following:
bradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders'
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start16 Sep 2021
- Primary completion30 Jan 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypotensionStudies 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
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250960
- Sponsor's protocol ID
- 21-020
- Status last verified
- Apr 2025
- First submitted
- 18 Feb 2022
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Pre-epidural Placement of Sequential Compression Devices (SCD) to Prevent Hypotension
- ClinicalTrials.gov ID
- NCT05250960
- Acronym / sponsor ID
- 21-020
- Conditions
- Hypotension, Labor Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:
- Arm 1: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
- Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Detailed description
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:
- Arm 1: Patient will receive 1liter (L) of lactated ringers (LR) and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
- Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs Outcome variables include occurrence of maternal hypotension or Category II fetal tracings in the first hour after epidural placement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - SCD arm | Experimental | Device: SCDPatient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement |
| Control - no SCD arm | No intervention | –Patient will receive 1L of LR during and after epidural placement with no use of SCDs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Laboring at Bethesda North Hospital Labor \& Delivery Unit
- Will receive epidural analgesia
- 37+ weeks gestation
- Singleton pregnancy
- Category 1 tracings only before epidural placement
Key exclusion criteria (13 listed)
- Under 18 years old
- Does not speak English
- Unable to consent to involvement in the research study
- Diagnosed with fetal demise
- Diagnosis of pre-existing hypertension
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 |
|---|---|---|
| SCDPatient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement | Device | Intervention - SCD arm |
Primary outcome
Hypotension
Time frame: 1 hour
SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)
Category II Tracings
Time frame: 1 hour
Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not Category II tracings - The classification of Category II tracings includes the following: bradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders'
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCD in people with Hypotension and Labor Complication, run by TriHealth Inc. 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 5 inclusion and 13 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 25 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hypotension (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2025.