VAIL: Visual Aids for Induction of Labor RCT
Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05671224
Collaborator
(none)
84
2
3
Study Details
Study Description
Brief Summary
This study aims to develop a visual aid tool for induction education informed by the experiences and needs of historically marginalized pregnant women, as well as determine the impact of the patient-informed visual aid on patient knowledge, satisfaction, and trust in physicians regarding induction methods.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a multi-phased study of patients undergoing IOL. Only the second phase of the study will be detailed in this protocol, as this will be the RCT portion of the study's design. We will test the efficacy of the visual aid by conducting a randomized trial of routine counseling versus counseling with the use of a visual aid (informed by patient interviews in the first phase) at the time of admission for IOL and studying the effect of the visual aid on patient knowledge, trust in providers, and satisfaction.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
84 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Using a web-based randomization sequence on REDCap, patients will be randomized in 1:1 ratio to standard counseling or counseling with a visual aid immediately prior to initiation of their IOL.Using a web-based randomization sequence on REDCap, patients will be randomized in 1:1 ratio to standard counseling or counseling with a visual aid immediately prior to initiation of their IOL.
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Visual Aids for Induction of Labor (IOL): A Randomized Controlled Trial for Assessment of Patient IOL Knowledge
Anticipated Study Start Date
:
Jan 20, 2023
Anticipated Primary Completion Date
:
Mar 20, 2023
Anticipated Study Completion Date
:
Apr 20, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard counseling Standard induction of labor counseling |
|
| Experimental: Visual aid counseling Counseling on induction of labor with either a video or a handout |
Other: Visual aid
Handout and video describing different types of induction of labor
|
Outcome Measures
Primary Outcome Measures
- Induction of labor knowledge [10 minutes (during completion of survey)]
Multiple choice questions
Secondary Outcome Measures
- Patient satisfaction [10 minutes (during completion of survey)]
Likert scale (1-10)
- Patient trust in providers survey [10 minutes (during completion of survey)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Patients scheduled for or admitted for induction of labor and who can speak, read, and write in the English language.
Exclusion Criteria:
- Patients undergoing induction termination or with a history of prior cesarean section, major fetal anomaly, known chromosomal anomaly, or fetal growth restriction with doppler abnormalities. Patients whose induction has already commenced will also be excluded.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Washington University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091.
- Bailey JM, Crane P, Nugent CE. Childbirth education and birth plans. Obstet Gynecol Clin North Am. 2008 Sep;35(3):497-509, ix. doi: 10.1016/j.ogc.2008.04.005.
- Beckmann M, Cooper C, Pocock D. INFORMed choices: facilitating shared decision-making in health care. Aust N Z J Obstet Gynaecol. 2015 Jun;55(3):294-7. doi: 10.1111/ajo.12343. Epub 2015 Jun 5.
- Berger B, Schwarz C, Heusser P. Watchful waiting or induction of labour--a matter of informed choice: identification, analysis and critical appraisal of decision aids and patient information regarding care options for women with uncomplicated singleton late and post term pregnancies: a review. BMC Complement Altern Med. 2015 May 7;15:143. doi: 10.1186/s12906-015-0663-y.
- Cahill AG, Tuuli MG, Stout MJ, Lopez JD, Macones GA. A prospective cohort study of fetal heart rate monitoring: deceleration area is predictive of fetal acidemia. Am J Obstet Gynecol. 2018 May;218(5):523.e1-523.e12. doi: 10.1016/j.ajog.2018.01.026. Epub 2018 Feb 1.
- Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
- Hamm RF, Srinivas SK, Levine LD. Risk factors and racial disparities related to low maternal birth satisfaction with labor induction: a prospective, cohort study. BMC Pregnancy Childbirth. 2019 Dec 30;19(1):530. doi: 10.1186/s12884-019-2658-z.
- Irani RA, Foster S. Overview of the mechanisms of induction of labor. Semin Perinatol. 2015 Oct;39(6):426-9. doi: 10.1053/j.semperi.2015.07.001. Epub 2015 Sep 11.
- 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.
- Rosenthal L, Lobel M. Gendered racism and the sexual and reproductive health of Black and Latina Women. Ethn Health. 2020 Apr;25(3):367-392. doi: 10.1080/13557858.2018.1439896. Epub 2018 Feb 15.
- Sperlich M, Gabriel C, St Vil NM. Preference, knowledge and utilization of midwives, childbirth education classes and doulas among U.S. black and white women: implications for pregnancy and childbirth outcomes. Soc Work Health Care. 2019 Nov-Dec;58(10):988-1001. doi: 10.1080/00981389.2019.1686679. Epub 2019 Nov 4.
Responsible Party:
Halley Staples,
Resident Physician,
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05671224
Other Study ID Numbers:
- 202301001
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No