Clinical trial NCT05671224: Visual Aids for Induction of Labor RCT
Official title: Visual Aids for Induction of Labor (IOL): A Randomized Controlled Trial for Assessment of Patient IOL Knowledge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Birth
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Induction of labor knowledge
timeFrame: 10 minutes (during completion of survey)
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 10 minutes (during completion of survey)
measure: Patient trust in providers survey
timeFrame: 10 minutes (during completion of survey)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Nandini Raghuraman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.