Trial Outcomes & Findings for Presence of a Companion During Performance of Neuraxial Labor Analgesia (NCT NCT02982213)

Last Updated: 2021-11-12

Results Overview

The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

Average 12 hours, up to 24 hours after epidural placement

Results posted on

2021-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	No Companion Present No companion is present during the placement of the epidural catheter.	Companion Present A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Overall Study STARTED	75	75
Overall Study COMPLETED	70	74
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	No Companion Present No companion is present during the placement of the epidural catheter.	Companion Present A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Overall Study Did not complete follow up questionnaire	5	1

Baseline Characteristics

In the companion not in the room group, 73 completed demographic data, 73 subjects received the intervention and 70 completed follow up.In the companion in the room group, 75 completed demographic data, 75 subjects received intervention and 74 completed follow up.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Average 12 hours, up to 24 hours after epidural placement

Outcome measures

Outcome measures
Measure	No Companion Present n=70 Participants No companion is present during the placement of the epidural catheter.	Companion Present n=74 Participants A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. Highly Dissatisfied	2 Participants	2 Participants
Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. Dissatisfied	3 Participants	0 Participants
Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. Neutral	11 Participants	1 Participants
Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. Satisfied	15 Participants	10 Participants
Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. Highly Satisfied	39 Participants	61 Participants

SECONDARY outcome

Timeframe: 24 hours after epidural placement

Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.

Outcome measures

Outcome measures
Measure	No Companion Present n=70 Participants No companion is present during the placement of the epidural catheter.	Companion Present n=74 Participants A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.	-7 score on scale Interval -13.0 to -1.0	-11 score on scale Interval -17.0 to -3.0

SECONDARY outcome

Timeframe: After epidural placement

Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).

Outcome measures

Outcome measures
Measure	No Companion Present n=70 Participants No companion is present during the placement of the epidural catheter.	Companion Present n=74 Participants A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.	8 score on scale Interval 6.5 to 9.0	8 score on scale Interval 7.0 to 9.0

SECONDARY outcome

Timeframe: 24 hours after epidural placement

What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.

Outcome measures

Outcome measures
Measure	No Companion Present n=73 Participants No companion is present during the placement of the epidural catheter.	Companion Present n=74 Participants A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
What is the Preference of Subjects to Have a Companion Present for Future Procedures. Likely	14 Participants	15 Participants
What is the Preference of Subjects to Have a Companion Present for Future Procedures. Neutral	22 Participants	14 Participants
What is the Preference of Subjects to Have a Companion Present for Future Procedures. Unlikely	7 Participants	5 Participants
What is the Preference of Subjects to Have a Companion Present for Future Procedures. Highly unlikely	10 Participants	10 Participants
What is the Preference of Subjects to Have a Companion Present for Future Procedures. Did not respond	3 Participants	0 Participants
What is the Preference of Subjects to Have a Companion Present for Future Procedures. Highly likely	17 Participants	30 Participants

SECONDARY outcome

Timeframe: 24 hours after epidural

Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.

Outcome measures

Outcome measures
Measure	No Companion Present n=73 Participants No companion is present during the placement of the epidural catheter.	Companion Present n=74 Participants A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. Highly likely	32 Participants	59 Participants
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. LIkely	10 Participants	11 Participants
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. Neutral	22 Participants	2 Participants
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. Unlikely	3 Participants	0 Participants
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. Highly unlikely	3 Participants	2 Participants
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. Did not respond	3 Participants	0 Participants

Adverse Events

No Companion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Companion Present

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

Feyce Peralta, MD

Northwestern University

Phone: 312-472-3585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Baseline characteristics by cohort
Measure	No Companion Present n=75 Participants No companion is present during the placement of the epidural catheter.	Companion Present n=75 Participants A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.	Total n=150 Participants Total of all reporting groups
Age, Continuous	32.2 years STANDARD_DEVIATION 3.8 • n=73 Participants • In the companion not in the room group, 73 completed demographic data, 73 subjects received the intervention and 70 completed follow up.In the companion in the room group, 75 completed demographic data, 75 subjects received intervention and 74 completed follow up.	31.8 years STANDARD_DEVIATION 3.6 • n=75 Participants • In the companion not in the room group, 73 completed demographic data, 73 subjects received the intervention and 70 completed follow up.In the companion in the room group, 75 completed demographic data, 75 subjects received intervention and 74 completed follow up.	32 years STANDARD_DEVIATION 3.7 • n=148 Participants • In the companion not in the room group, 73 completed demographic data, 73 subjects received the intervention and 70 completed follow up.In the companion in the room group, 75 completed demographic data, 75 subjects received intervention and 74 completed follow up.
Sex: Female, Male Female	75 Participants n=75 Participants	75 Participants n=75 Participants	150 Participants n=150 Participants
Sex: Female, Male Male	0 Participants n=75 Participants	0 Participants n=75 Participants	0 Participants n=150 Participants
Race/Ethnicity, Customized Caucasian	52 Participants n=75 Participants	48 Participants n=75 Participants	100 Participants n=150 Participants
Race/Ethnicity, Customized African American	4 Participants n=75 Participants	5 Participants n=75 Participants	9 Participants n=150 Participants
Race/Ethnicity, Customized Asian	11 Participants n=75 Participants	11 Participants n=75 Participants	22 Participants n=150 Participants
Race/Ethnicity, Customized Latino/Hispanic	6 Participants n=75 Participants	10 Participants n=75 Participants	16 Participants n=150 Participants
Race/Ethnicity, Customized Question not answered	2 Participants n=75 Participants	1 Participants n=75 Participants	3 Participants n=150 Participants
Region of Enrollment United States	75 participants n=75 Participants	75 participants n=75 Participants	147 participants n=150 Participants
Body Mass Index	29.2 kg/m2 STANDARD_DEVIATION 4.7 • n=75 Participants	29.6 kg/m2 STANDARD_DEVIATION 7.3 • n=75 Participants	29.4 kg/m2 STANDARD_DEVIATION 6.1 • n=150 Participants
Gestational Age	40 Weeks n=72 Participants • In the companion not in the room group 72 completed gestational data and in the companion group 73 completed the gestational data. .	40 Weeks n=73 Participants • In the companion not in the room group 72 completed gestational data and in the companion group 73 completed the gestational data. .	40 Weeks n=145 Participants • In the companion not in the room group 72 completed gestational data and in the companion group 73 completed the gestational data. .
NRS pain score	7 units on a scale n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery	7 units on a scale n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery	7 units on a scale n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery
Cervical Dilation	3 centimeters n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed .	3.5 centimeters n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed .	3 centimeters n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed .
Labor Type Induction	44 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	38 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	82 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Labor Type Spontaneous labor	29 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	36 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	65 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Labor epidural procedural expectations None	4 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	4 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	8 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Labor epidural procedural expectations Short procedure minimal pain	49 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	53 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	102 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Labor epidural procedural expectations Long procedure pain not mentioned	3 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	0 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	3 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Labor epidural procedural expectations Painful procedure	13 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	13 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	26 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Labor epidural procedural expectations Other than pain or duration	4 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	4 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	8 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Greatest concern regarding epidural procedure Pain during procedure	23 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	20 Participants n=75 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	43 Participants n=148 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).
Greatest concern regarding epidural procedure Unable to tolerate procedure	4 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	4 Participants n=75 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	8 Participants n=148 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).
Greatest concern regarding epidural procedure Ineffective analgesia	17 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	14 Participants n=75 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	31 Participants n=148 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).
Greatest concern regarding epidural procedure Complications	23 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	28 Participants n=75 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	51 Participants n=148 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).
Greatest concern regarding epidural procedure Other	6 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	9 Participants n=75 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).	15 Participants n=148 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).
Have you spoken to friends or family about labor epidurals? Yes-positive comments	53 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	49 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	102 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Have you spoken to friends or family about labor epidurals? Yes-mixed comments	13 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	13 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	26 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Have you spoken to friends or family about labor epidurals? Yes-mostly negative comments	1 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	3 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	4 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Have you spoken to friends or family about labor epidurals? Did not respond	6 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	9 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	15 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Researched epidurals through social media? Yes	37 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	43 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	80 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Researched epidurals through social media? No	36 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	31 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	67 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Relationship of primary companion Male partner	62 Participants n=75 Participants	65 Participants n=75 Participants	127 Participants n=150 Participants
Relationship of primary companion Female partner	10 Participants n=75 Participants	6 Participants n=75 Participants	16 Participants n=150 Participants
Relationship of primary companion Brother	1 Participants n=75 Participants	0 Participants n=75 Participants	1 Participants n=150 Participants
Relationship of primary companion Aunt	0 Participants n=75 Participants	1 Participants n=75 Participants	1 Participants n=150 Participants
Relationship of primary companion Friend	2 Participants n=75 Participants	3 Participants n=75 Participants	5 Participants n=150 Participants
How long have you known your companion (years)?	7.5 Years n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	7 Years n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	7 Years n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Work in medical field? Yes	12 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	12 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	24 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Work in medical field? No	61 Participants n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	62 Participants n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	123 Participants n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)
Preprocedure pain catastrophizing scale Median (quartile)	12 units on a scale n=73 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	17 units on a scale n=74 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)	14 units on a scale n=147 Participants • 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)