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Patient Education on Labor Analgesia Options

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ClinicalTrials.gov Identifier: NCT02557555
Recruitment Status : Completed
First Posted : September 23, 2015
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Antonio Gonzalez Fiol, Anesthesiology Department, Rutgers, The State University of New Jersey

Brief 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. The options for analgesia will be discussed by anesthesia care provider. Patient will be asked to complete a survey on the post partum unit.

Condition or disease Intervention/treatment
Labor Analgesia Other: educational information

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. Forty-seven percent of minority women feel inadequately educated about anesthesia, are less likely to trust physicians, and are less likely to receive epidurals. However, greater than 10% of obese women changed their preference toward epidural analgesia following antenatal consultation. Also, 50% of patients planning for analgesia-free labor request neuraxial analgesia after experiencing labor pain.3 Additionally, the question exists as to the quality of informed consent from a patient undergoing contraction pain and possible sedation from analgesic medications. The consensus is that parturients can provide informed consent. However, the process of informed consent for labor analgesia is not standardized; the options and risks presented to patients are dependent upon the individual practitioner obtaining the consent. Regarding epidurals, patients want to be informed of all risks and complications associated with the procedure. The patient's recall of the risks and benefits of the epidural procedure improved by 50% with written material in addition to verbal discussion, and recall improved by more than a factor of five when consent during labor was preceded by antenatal education. Parturients want a "pre-operative" visit with an anesthesiologist and have a strong desire for pre-labor education of anesthesia/analgesia options. Early antenatal education allows for time to teach, relieves anxiety, develops rapport, and provides opportunities for additional testing, if needed. Finally, the timing of epidural placement has not been shown to change outcomes, but when initiated late in the labor process, often other analgesia modalities were used that confounded the analysis of outcomes. Therefore, earlier request, which may come with prior knowledge and avoidance of misconceptions, and earlier placement of epidurals may lead to fewer analgesic interventions in the parturient and possibly less morbidity for the patient and fetus. 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 Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Antenatal and Perinatal Education of Labor Analgesia Options on Maternal Anxiety, Labor Analgesia and Maternal Satisfaction With Labor Analgesia
Actual Study Start Date : September 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: educational information
    patients will receive pamphlet on labor analgesia options.


Primary Outcome Measures :
  1. 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>?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant females in prenatal clinic and labor suite
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557555


Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Antonio Gonzalez-Fiol, MD Rutgers, NJMS

Responsible Party: Antonio Gonzalez Fiol, Anesthesiology Department, Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02557555     History of Changes
Other Study ID Numbers: 20150001531
First Posted: September 23, 2015    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017