NCT02557555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

September 18, 2015

Results QC Date

April 6, 2017

Last Update Submit

October 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

patients will receive pamphlet on labor analgesia options.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant females in prenatal clinic and labor suite

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

Results Point of Contact

Title
Assistant Professor
Organization
Rutgers New Jersey Medical School

Study Officials

  • Antonio Gonzalez-Fiol, MD

    Rutgers, NJMS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 23, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 7, 2019

Results First Posted

July 2, 2017

Record last verified: 2019-10

Locations