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During interim analysis, it appeared there were no difference in groups
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Labor patients who meet inclusion and exclusion criteria will be consented to be participate in this study to determine if the use of a peanut shaped birthing ball reduces the length of labor and reduces the incidence of cesarean section. Subjects will be randomized at the time of consent to either use the birthing ball or not use the birthing ball from the time of labor analgesia until complete cervical dilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peanut ball | Active Comparator | the peanut shaped birthing ball after labor analgesia will be utilized |
|
| no peanut ball | No Intervention | the peanut shaped birthing ball will not be utilized during labor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peanut shaped birthing ball | Other | peanut ball will be utilized |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Labor | time in minutes will be calculated from epidural catheter insertion until delivery | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Satisfaction | 11-point scale of 0=not satisfied up to 10=most satisfied of all | length of labor, up to 24 hours |
| Participant Cesarean Delivery Incidence-Mode of Deliveries | the number of subjects who had to had a cesarean delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D'Angelo, MD | WakeForest School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novant Health-Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16129992 | Background | Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available. | |
| 9875879 | Background | Halpern SH, Leighton BL, Ohlsson A, Barrett JF, Rice A. Effect of epidural vs parenteral opioid analgesia on the progress of labor: a meta-analysis. JAMA. 1998 Dec 23-30;280(24):2105-10. doi: 10.1001/jama.280.24.2105. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peanut Ball | the peanut shaped birthing ball after labor analgesia will be utilized peanut shaped birthing ball: peanut ball will be utilized |
| FG001 | no Peanut Ball | the peanut shaped birthing ball will not be utilized during labor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peanut Ball | the peanut shaped birthing ball after labor analgesia will be utilized peanut shaped birthing ball: peanut ball will be utilized |
| BG001 | no Peanut Ball | the peanut shaped birthing ball will not be utilized during labor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Length of Labor | time in minutes will be calculated from epidural catheter insertion until delivery | Posted | Mean | Standard Deviation | minutes | up to 24 hours |
|
|
thoughout the length of labor
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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 | Peanut Ball | the peanut shaped birthing ball after labor analgesia will be utilized peanut shaped birthing ball: peanut ball will be utilized |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynnette Harris, BSN | Wake Forest School of Medicine | 336-716-6049 | lcharris@wakehealth.edu |
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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 | Jun 1, 2015 | Aug 16, 2018 | Prot_SAP_000.pdf |
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| up to 24 hours |
| Number of Participants With Post-delivery Complications | Number of participants that had post-delivery complications was reported | up to 24 hours |
| Background | Martin JA, et al. Births: Final Report 2013. National Vital Statistics Report, 2015; Vol 64: Number 1. Also accessed at: http://www.cdc.gov/nchs/fastats/delivery.htm. |
| 24565430 | Background | American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026. |
| 26937158 | Background | Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing Length of Labor and Cesarean Surgery Rate Using a Peanut Ball for Women Laboring With an Epidural. J Perinat Educ. 2015;24(1):16-24. doi: 10.1891/1058-1243.24.1.16. |
| 10519493 | Background | Tsen LC, Thue B, Datta S, Segal S. Is combined spinal-epidural analgesia associated with more rapid cervical dilation in nulliparous patients when compared with conventional epidural analgesia? Anesthesiology. 1999 Oct;91(4):920-5. doi: 10.1097/00000542-199910000-00010. |
| 14199536 | Background | BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | analysis performed on those completing study only | Mean | Standard Deviation | centimeters |
|
| Weight | analysis performed on those completing study only | Mean | Standard Deviation | kilograms |
|
| Gestational Age | Mean | Standard Deviation | weeks |
|
| Oxytocin Augmentation | those receiving oxytocin in order for labor to be augmented | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Maternal Satisfaction | 11-point scale of 0=not satisfied up to 10=most satisfied of all | Posted | Mean | Standard Deviation | units on a scale | length of labor, up to 24 hours |
|
|
|
| Secondary | Participant Cesarean Delivery Incidence-Mode of Deliveries | the number of subjects who had to had a cesarean delivery | Posted | Number | number of cesarean deliveries | up to 24 hours |
|
|
|
| Secondary | Number of Participants With Post-delivery Complications | Number of participants that had post-delivery complications was reported | Posted | Count of Participants | Participants | up to 24 hours |
|
|
|
| Post-Hoc | Cervical Dilation | rate in centimeters per hour of dilation | rate of cervical dilation in centimeters per hour that subjects dilated in each group | Posted | Mean | Standard Deviation | centimeters per hour | length of labor, up to 24 hours |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | no Peanut Ball | the peanut shaped birthing ball will not be utilized during labor | 0 | 42 | 0 | 42 | 0 | 42 |
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