Trial Outcomes & Findings for Should I Have an Elective Induction? (NCT NCT05838313)

Results Overview

Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

32-38 weeks gestation

Results posted on

2025-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Decision Support Tool Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Overall Study STARTED	66
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Should I Have an Elective Induction?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Support Tool n=66 Participants Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Age, Continuous	29.2 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 32-38 weeks gestation

Population: Recruitment rate will be calculated based on the number of people approached who were eligible and agreed to participate in the study

Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study

Outcome measures

Outcome measures
Measure	Decision Support Tool n=176 Participants Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Recruitment Rate	66 Participants

PRIMARY outcome

Timeframe: 36-38 weeks gestation

Population: All participants interacting with the decision support tool

The proportion of participants who view all of the pages of the decision support tool will be calculated

Outcome measures

Outcome measures
Measure	Decision Support Tool n=66 Participants Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Proportion of People Completely Viewing the Decision Support Tool	52 Participants

SECONDARY outcome

Timeframe: 36-38 weeks gestation

Population: Participants completing questionnaire after interacting with the decision support tool

4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	Decision Support Tool n=66 Participants Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Satisfaction With the Decision Support Tool	17.4 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 38-39 weeks gestation, prior to delivery

Population: Participants completing follow up questionnaire at 38-39 weeks gestation, prior to delivery

4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	Decision Support Tool n=49 Participants Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Satisfaction With the Decision Support Tool	17.0 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 2-4 weeks Postpartum

Population: Participants completing follow up questionnaire at 2-4 weeks postpartum

5 point scale (Strongly disagree to Strongly agree, 5=Strongly agree) "Viewing the App affected my decision making"

Outcome measures

Outcome measures
Measure	Decision Support Tool n=52 Participants Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Impact of App on Decision Making	2.8 units on a scale Standard Deviation 1.1

Adverse Events

Decision Support Tool

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

Anjali Kaimal, MD, MAS

University of South Florida Morsani College of Medicine, Department of Obstetrics and Gynecology

Phone: (813) 259-8680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place