Labor AnalgesiaNCT02557555
Patient Education on Labor Analgesia Options
An observational study of Labor Analgesia, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- educational information
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2017
- Phase
- Observational
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant females in prenatal clinic and labor suite
Who may be able to join
- Postpartum women ages 18 and older
- Patients who speak and read English or Spanish
- Patients who received our informational pamphlet while pregnant or in labor
- Patients who are able to consent and make medical decisions
- Patients undergoing labor or trial of labor after cesarean delivery
- Patients who undergo cesarean delivery after trial of labor
Who cannot join
- Patients unable or unwilling to complete questionnaire
- Patients unable to consent or make medical decisions
- Patients less than 18 years of age
- Patients unable to read and speak English or Spanish
- Patients in whom any of the analgesic options were contraindicated
- Patients with a history of an anxiety disorder
Show all 9Show fewer
- Patients with precipitous labor or late presentation that precluded an analgesic intervention
- Patients with fetal distress that precluded an analgesic intervention
- Patients planned for elective cesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Antenatal and Perinatal Education of Labor Analgesia Options on Maternal Anxiety, Labor Analgesia and Maternal Satisfaction With Labor Analgesia
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.
Read the detailed description
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.
- Conditions
- Labor Analgesia
- Being tested
- educational information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational informationOther
patients will receive pamphlet on labor analgesia options.
What is being measured
The primary outcome is the main question the study is designed to answer.
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>?
Measured: expected average of no later than 48 hours following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionMar 2017
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 Labor AnalgesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Gonzalez Fiol, Anesthesiology Department, Rutgers, The State University of New Jersey
- Investigators
- Antonio Gonzalez-Fiol, MD, Principal investigator, Rutgers, NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557555
- Sponsor's protocol ID
- 20150001531
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2015
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antenatal and Perinatal Education of Labor Analgesia Options on Maternal Anxiety, Labor Analgesia and Maternal Satisfaction With Labor Analgesia
- ClinicalTrials.gov ID
- NCT02557555
- Acronym / sponsor ID
- 20150001531
- Conditions
- Labor Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant females in prenatal clinic and labor suite
Key inclusion criteria (6 listed)
- Postpartum women ages 18 and older
- Patients who speak and read English or Spanish
- Patients who received our informational pamphlet while pregnant or in labor
- Patients who are able to consent and make medical decisions
- Patients undergoing labor or trial of labor after cesarean delivery
Key exclusion criteria (9 listed)
- Patients unable or unwilling to complete questionnaire
- Patients unable to consent or make medical decisions
- Patients less than 18 years of age
- Patients unable to read and speak English or Spanish
- Patients in whom any of the analgesic options were contraindicated
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 |
|---|---|---|
| educational informationpatients will receive pamphlet on labor analgesia options. | Other | – |
Primary outcome
Survey to Determine Utility and Effect of Educational Materials
Time frame: expected average of no later than 48 hours following delivery
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>?
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Antonio Gonzalez-Fiol, MD principal investigator
Rutgers, NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Analgesia, run by Rutgers, The State University of New Jersey 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 6 inclusion and 9 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 7 Oct 2019. 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 2 Jul 2017). 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?
Survey to Determine Utility and Effect of Educational Materials (time frame: expected average of no later than 48 hours following delivery). 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 7 Oct 2019.