Trial Outcomes & Findings for Visual Aids for Induction of Labor RCT (NCT NCT05671224)
NCT ID: NCT05671224
Last Updated: 2026-07-27
Results Overview
Percentage of correct answers on survey measure of IOL knowledge adapted from Rahman et al (2022)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
After receiving intervention
Results posted on
2026-07-27
Participant Flow
Enrolled participant not randomized due to randomization goal being reached, n=1
Participant milestones
| Measure |
Standard Counseling
Standard induction of labor counseling
|
Visual Aid Counseling
Counseling on induction of labor with either a video or a handout
Visual aid: Handout and video describing different types of induction of labor
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
42
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Refused, n=2
Baseline characteristics by cohort
| Measure |
Standard Counseling
n=42 Participants
Standard induction of labor counseling
|
Visual Aid Counseling
n=42 Participants
Counseling on induction of labor with either a video or a handout
Visual aid: Handout and video describing different types of induction of labor
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 4.9 • n=42 Participants
|
32.1 years
STANDARD_DEVIATION 5.1 • n=42 Participants
|
31.4 years
STANDARD_DEVIATION 5.0 • n=84 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
84 Participants
n=84 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=84 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=84 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
80 Participants
n=84 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=84 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
26 Participants
n=84 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
54 Participants
n=84 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=84 Participants
|
|
Insurance Type
Commercial
|
30 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
60 Participants
n=84 Participants
|
|
Insurance Type
Public
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
24 Participants
n=84 Participants
|
|
Level of Education
Less than or equal to High School/GED
|
12 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
18 Participants
n=84 Participants
|
|
Level of Education
Some college/Associate's degree
|
6 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
17 Participants
n=84 Participants
|
|
Level of Education
4+ Year Degree
|
24 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
49 Participants
n=84 Participants
|
|
Marital Status
Single
|
12 Participants
n=42 Participants • Refused, n=2
|
12 Participants
n=40 Participants • Refused, n=2
|
24 Participants
n=82 Participants • Refused, n=2
|
|
Marital Status
Married/Partnered
|
30 Participants
n=42 Participants • Refused, n=2
|
28 Participants
n=40 Participants • Refused, n=2
|
58 Participants
n=82 Participants • Refused, n=2
|
|
Currently Employed
Yes
|
29 Participants
n=42 Participants • Refused, n=1
|
30 Participants
n=41 Participants • Refused, n=1
|
59 Participants
n=83 Participants • Refused, n=1
|
|
Currently Employed
No
|
13 Participants
n=42 Participants • Refused, n=1
|
11 Participants
n=41 Participants • Refused, n=1
|
24 Participants
n=83 Participants • Refused, n=1
|
|
Nulliparous
|
16 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
41 Participants
n=84 Participants
|
|
Gestational age at induction
|
39.1 weeks
n=42 Participants
|
39.1 weeks
n=42 Participants
|
39.1 weeks
n=84 Participants
|
|
Maternal BMI
|
28.3 kg/m^2
n=41 Participants • Missing data, n=2
|
28.1 kg/m^2
n=41 Participants • Missing data, n=2
|
28.3 kg/m^2
n=82 Participants • Missing data, n=2
|
|
Medical Comorbidities
Gestational Diabetes
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=84 Participants
|
|
Medical Comorbidities
Hypertensive disorders of pregnancy
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
13 Participants
n=84 Participants
|
|
Medical Comorbidities
Chronic Hypertension
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
11 Participants
n=84 Participants
|
|
Substance Use
Tobacco
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=84 Participants
|
|
Substance Use
Alcohol
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=84 Participants
|
|
Substance Use
Other Substance
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=84 Participants
|
|
Indication for Induction
Risk reducing
|
24 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
53 Participants
n=84 Participants
|
|
Indication for Induction
Chronic hypertension
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=84 Participants
|
|
Indication for Induction
Gestational hypertension
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=84 Participants
|
|
Indication for Induction
Pre-eclampsia
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=84 Participants
|
|
Indication for Induction
Fetal growth restriction
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=84 Participants
|
|
Indication for Induction
Type I or Type II Diabetes
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=84 Participants
|
|
Indication for Induction
Fetal decelerations
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=84 Participants
|
|
Indication for Induction
Other
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=84 Participants
|
PRIMARY outcome
Timeframe: After receiving interventionPercentage of correct answers on survey measure of IOL knowledge adapted from Rahman et al (2022)
Outcome measures
| Measure |
Visual Aid Counseling
n=42 Participants
Counseling on induction of labor with either a video or a handout
Visual aid: Handout and video describing different types of induction of labor
|
Standard Counseling
n=42 Participants
Standard induction of labor counseling
|
|---|---|---|
|
Induction of Labor Knowledge
|
80 percentage of correct answers
Interval 60.0 to 90.0
|
70 percentage of correct answers
Interval 60.0 to 90.0
|
SECONDARY outcome
Timeframe: After receiving intervention0-10 scale; higher scores indicate higher satisfaction
Outcome measures
| Measure |
Visual Aid Counseling
n=42 Participants
Counseling on induction of labor with either a video or a handout
Visual aid: Handout and video describing different types of induction of labor
|
Standard Counseling
n=42 Participants
Standard induction of labor counseling
|
|---|---|---|
|
Patient Satisfaction With IOL Counseling
|
10 units on a scale
Interval 9.0 to 10.0
|
9 units on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: 10 minutes (during completion of survey)Population: Missing data are due to participants skipping questions
Patients' self-reported trust in providers using a 10-item survey
Outcome measures
| Measure |
Visual Aid Counseling
n=42 Participants
Counseling on induction of labor with either a video or a handout
Visual aid: Handout and video describing different types of induction of labor
|
Standard Counseling
n=42 Participants
Standard induction of labor counseling
|
|---|---|---|
|
Patient Trust in Providers Survey
The information I received from the physician helped me to choose an induction method today · Unsure
|
1 Participants
|
1 Participants
|
|
Patient Trust in Providers Survey
I understood why the physician recommended certain induction methods · Yes
|
41 Participants
|
40 Participants
|
|
Patient Trust in Providers Survey
The physician answered my questions about labor induction · Unsure
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
It was easy to share personal information about myself with the physician · Yes
|
42 Participants
|
41 Participants
|
|
Patient Trust in Providers Survey
It was easy to share personal information about myself with the physician · No
|
0 Participants
|
1 Participants
|
|
Patient Trust in Providers Survey
It was easy to share personal information about myself with the physician · Unsure
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
I trust the physician will keep the information we discuss private · Yes
|
42 Participants
|
42 Participants
|
|
Patient Trust in Providers Survey
I trust the physician will keep the information we discuss private · No
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
I trust the physician will keep the information we discuss private · Unsure
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
I feel that the physician respected me · Yes
|
40 Participants
|
42 Participants
|
|
Patient Trust in Providers Survey
I feel that the physician respected me · No
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
I feel that the physician respected me · Unsure
|
1 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
I understood why the physician recommended certain induction methods · No
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
I understood why the physician recommended certain induction methods · Unsure
|
0 Participants
|
2 Participants
|
|
Patient Trust in Providers Survey
I feel like the physician was judging me today · Yes
|
40 Participants
|
40 Participants
|
|
Patient Trust in Providers Survey
I feel like the physician was judging me today · No
|
1 Participants
|
1 Participants
|
|
Patient Trust in Providers Survey
I feel like the physician was judging me today · Unsure
|
1 Participants
|
1 Participants
|
|
Patient Trust in Providers Survey
The information I received from the physician helped me to choose an induction method today · Yes
|
39 Participants
|
37 Participants
|
|
Patient Trust in Providers Survey
The information I received from the physician helped me to choose an induction method today · No
|
2 Participants
|
4 Participants
|
|
Patient Trust in Providers Survey
The physician gave me enough information to choose an induction method today · Yes
|
40 Participants
|
41 Participants
|
|
Patient Trust in Providers Survey
The physician gave me enough information to choose an induction method today · No
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
The physician gave me enough information to choose an induction method today · Unsure
|
2 Participants
|
1 Participants
|
|
Patient Trust in Providers Survey
I trust the information the physician gave me about labor induction · Yes
|
41 Participants
|
42 Participants
|
|
Patient Trust in Providers Survey
I trust the information the physician gave me about labor induction · No
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
I trust the information the physician gave me about labor induction · Unsure
|
1 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
The information the physician gave me about labor induction was easy to understand · Yes
|
40 Participants
|
41 Participants
|
|
Patient Trust in Providers Survey
The information the physician gave me about labor induction was easy to understand · No
|
0 Participants
|
0 Participants
|
|
Patient Trust in Providers Survey
The information the physician gave me about labor induction was easy to understand · Unsure
|
2 Participants
|
1 Participants
|
|
Patient Trust in Providers Survey
The physician answered my questions about labor induction · Yes
|
42 Participants
|
40 Participants
|
|
Patient Trust in Providers Survey
The physician answered my questions about labor induction · No
|
0 Participants
|
1 Participants
|
Adverse Events
Standard Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Visual Aid Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Counseling
n=42 participants at risk
Standard induction of labor counseling
|
Visual Aid Counseling
n=42 participants at risk
Counseling on induction of labor with either a video or a handout
Visual aid: Handout and video describing different types of induction of labor
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Life-threatening maternal admission
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Maternal admission to the intensive care unit
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Unplanned hysterectomy
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Life-threatening neonatal event
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Serious neonatal birth injury
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
Other adverse events
| Measure |
Standard Counseling
n=42 participants at risk
Standard induction of labor counseling
|
Visual Aid Counseling
n=42 participants at risk
Counseling on induction of labor with either a video or a handout
Visual aid: Handout and video describing different types of induction of labor
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Acidemia
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Chorioamnionitis in the second stage of labor
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Severe postpartum hemorhage
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal intensive care unit (NICU) admission
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
0.00%
0/42 • Delivery admission, from randomization until hospital discharge of mother and infant, up to one week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place