Trial Outcomes & Findings for Patient Education on Labor Analgesia Options (NCT NCT02557555)

Results Overview

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\>?

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

expected average of no later than 48 hours following delivery

Results posted on

2019-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Labor Pain Control Pamphlet n=100 Participants 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.
Age, Customized 18-45 years	100 Participants n=100 Participants
Sex: Female, Male Female	100 Participants n=100 Participants
Sex: Female, Male Male	0 Participants n=100 Participants
Region of Enrollment United States	100 participants n=100 Participants
Patients completing survey	100 Participants n=100 Participants

PRIMARY outcome

Timeframe: expected average of no later than 48 hours following delivery

Population: 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.

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\>?

Outcome measures

Outcome measures
Measure	Yes % n=100 Participants Percentage of patients responding Yes to one of the key questions of the study regarding education value of the pamphlet and anxiety level.	No % n=100 Participants Percentage of patients responding no to the key questions regarding the provided pamphlet educational value or anxiety
Survey to Determine Utility and Effect of Educational Materials Researched options for labor pain	79 percentage of patients responding	21 percentage of patients responding
Survey to Determine Utility and Effect of Educational Materials Pamphlet better explained options for pain	93 percentage of patients responding	7 percentage of patients responding
Survey to Determine Utility and Effect of Educational Materials Pamphlet should be given before onset labor pain	97 percentage of patients responding	3 percentage of patients responding
Survey to Determine Utility and Effect of Educational Materials Pamphlet information helped to reduce anxiety	90 percentage of patients responding	10 percentage of patients responding
Survey to Determine Utility and Effect of Educational Materials Information corrected any misconception	71 percentage of patients responding	29 percentage of patients responding
Survey to Determine Utility and Effect of Educational Materials Written information should always be available	100 percentage of patients responding	0 percentage of patients responding

Adverse Events

Labor Pain Control Pamphlet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Professor

Rutgers New Jersey Medical School

Phone: 4133869415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place