NCT04537260

Brief Summary

The investigators have created a brief, 3-minute video that discusses the induction of labor process. The aim of this study is to evaluate, via a randomized method, how this educational video impact's patients' knowledge and satisfaction with the induction of labor process. Purpose: Evaluate how an educational video impacts patients' knowledge and satisfaction with the induction of labor process Research questions:

  1. 1.Does a brief educational video improve patients' baseline knowledge of the induction of labor process when compared to patients' who receive traditional care?
  2. 2.Does a brief educational video improve patients' overall satisfaction with their delivery course when compared to patients' who received the standard care? Hypothesis: Those patients' shown a brief educational video will have a higher baseline knowledge about the induction process and higher satisfaction with their delivery course compared to patients who received the standard in-office counseling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

August 25, 2020

Last Update Submit

August 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knowledge of Induction of Labor

    Evaluating if a 3-minute educational video changes patients' baseline knowledge of the induction of labor process when compared to patients' who receive traditional care via a questionnaire.

    3 minute knowledge based questionnaire given to both arms prior to meeting with a provider (midwife or obstetrician).

Secondary Outcomes (1)

  • Satisfaction with Induction of Labor Process

    3 minute satisfaction questionnaire given to both arms 24 to 48 hours after delivery at a time convenient for them.

Study Arms (2)

Control Arm (Standard of Care)

NO INTERVENTION

The control group took the knowledge-based survey about induction of labor prior to meeting their provider (midwife or obstetrician) on the day of scheduled induction. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction with the labor and delivery process.

Intervention Arm (Educational video)

EXPERIMENTAL

The intervention group had the opportunity to watch the 3-minute educational video. The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8. After watching the video, the participant was asked to take the knowledge-based survey. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction.

Behavioral: Educational Video

Interventions

Those in the intervention arm were asked to watch the 3-minute educational video prior to the knowledge questionnaire and meeting their provider (midwife or obstetrician). The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8.

Intervention Arm (Educational video)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • English speaking
  • Scheduled for induction of labor at the George Washington University Hospital

You may not qualify if:

  • \< 18 years of age
  • Does not speak English
  • Not scheduled for an induction of labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

  • Rahman S, Kripalani S, Keegan E, Sparks A, Amdur R, Moawad G, Sheth S, Klebanoff J. An educational video's impact on the induction of labor experience: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100495. doi: 10.1016/j.ajogmf.2021.100495. Epub 2021 Sep 24.

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sara H Rahman, MD

    Dr.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The research member enrolling the patient in the study, the participant, and the person collecting the questionnaires were all blind to what arm of the study the participant would be placed into (control vs intervention with video group). A computer-generated allocation sequence to determine randomization. Randomization assignments were placed in sealed, opaque envelopes that were opened sequentially after verbal and signed consent was obtained for the study. The research team members who collected the outcome data (example, parity, delivery method, etc) was also blind to which arm the participant was assigned too.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were either enrolled in the control arm (no intervention) or the intervention group (3-minute educational video intervention)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 3, 2020

Study Start

October 1, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations