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The purpose of this study is to learn how the investigators can better educate pregnant patients about the options open to them for pain relief during labor. Patients will receive educational pamphlet during prenatal clinic visit and again on admission to labor and delivery. The options for analgesia will be discussed by anesthesia care provider. Patient will be asked to complete a survey on the post partum unit.
Many analgesic options exist for laboring parturients, but labor may not be the best time to start informing patients of their options. Many patients begin the labor process with a plan in place for their analgesia. Unfortunately, internet resources regarding labor analgesia that are available to the lay parturient are poor and often lead to misconceptions about the options and their risks. A significant number of patients refuse neuraxial analgesia based on misunderstandings, concerns about the procedure, or a lack of faith in the provider. Some women want a "natural childbirth" and/or control over their labor experience. Our study aimed at providing information and alternatives for labor analgesia in a simple written format.
The investigators will provide information of available labor analgesia options (epidural, combined spinal/epidural, spinal, remifentanil patient-controlled analgesia, and intravenous opioids) to expecting mothers. Using a pamphlet written in English or Spanish disseminated to pregnant women in clinic and upon arrival in the labor and delivery unit, the procedures and their risks and benefits will be explained in simple terms. In the Labor and Delivery Unit the patients will have an opportunity to ask questions of the anesthesia care giver regarding the options for analgesia. After delivery while on F Green, patients will be asked to complete a questionnaire addressing their thoughts about the pamphlets and their overall satisfaction with their labor analgesia. The analysis will focus on the utility and effect of education materials on maternal informed consent for labor analgesia, on maternal choice of analgesia modality, and on maternal anxiety regarding their labor analgesia plan.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational information | Other | patients will receive pamphlet on labor analgesia options. |
| Measure | Description | Time Frame |
|---|---|---|
| Survey to Determine Utility and Effect of Educational Materials | In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education. There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions. For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>? | expected average of no later than 48 hours following delivery |
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Inclusion Criteria:
Exclusion Criteria:
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pregnant females in prenatal clinic and labor suite
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gonzalez-Fiol, MD | Rutgers, NJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Labor Pain Control Pamphlet | All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil patient controlled analgesia, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Labor Pain Control Pamphlet | All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Patients age 18-45 admitted to labor and delivery |
| 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 | Survey to Determine Utility and Effect of Educational Materials | In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education. There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions. For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>? | The answers from 100 female patients, ages 18-45 admitted to the L&D who answered our survey were analyzed to gage the educational value of our labor analgesia informational pamphlet. | Posted | Number | percentage of patients responding | expected average of no later than 48 hours following delivery |
|
1 year
Given that the patients were asked to fill up a 24 question survey, no patient was exposed to any risk. That is, there was no interventional or placebo/drug arm in this study.
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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 | Labor Pain Control Pamphlet | All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor | Rutgers New Jersey Medical School | 4133869415 | ajantoni@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2015 | Jul 21, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 30, 2015 | Jul 21, 2017 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2018 | Oct 31, 2018 | SAP_002.pdf |
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| Count of Participants |
| Participants |
|
| 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 |
|
| Patients completing survey | Count of Participants | Participants |
|
Percentage of patients responding Yes to one of the key questions of the study regarding education value of the pamphlet and anxiety level.
| OG001 | No % | Percentage of patients responding no to the key questions regarding the provided pamphlet educational value or anxiety |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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