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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control - no SCD arm | No Intervention | Patient will receive 1L of LR during and after epidural placement with no use of SCDs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCD | Device | Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer) | 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' | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
Laboring women only
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention - Sequential Compression Devices (SCD) Arm | 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 SCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement |
| FG001 | Control - no Sequential Compression Devices (SCD) Arm | Patient will receive 1L of LR during and after epidural placement with no use of SCDs |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention - SCD Arm | Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement SCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hypotension | SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer) | Posted | Number | participants | 1 hour |
|
During delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - SCD Arm | Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement SCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Baker | TriHealth | 513-569-6191 | Rachel_Baker2@trihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2022 | Feb 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Control - no SCD Arm |
Patient will receive 1L of LR during and after epidural placement with no use of SCDs |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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' | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Control - no SCD Arm | Patient will receive 1L of LR during and after epidural placement with no use of SCDs | 0 | 56 | 0 | 56 | 0 | 56 |
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| D000091642 | Urogenital Diseases |