Visual Aids for Induction of Labor RCT

NCT05671224 | Completed DMC

• 1 other identifier: 202301001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced; Birth

Outcome Measures

Primary Outcomes (1)

• Induction of labor knowledge

  Multiple choice questions

  10 minutes (during completion of survey)

Secondary Outcomes (2)

• Patient satisfaction

  10 minutes (during completion of survey)

• Patient trust in providers survey

  10 minutes (during completion of survey)

Study Arms (2)

Standard counseling

NO INTERVENTION

Standard induction of labor counseling

Visual aid counseling

EXPERIMENTAL

Counseling on induction of labor with either a video or a handout

Other: Visual aid

Interventions

Visual aid OTHER

Handout and video describing different types of induction of labor

Visual aid counseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for or admitted for induction of labor and who can speak, read, and write in the English language.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (11)

• 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.

  PMID: 30089070 BACKGROUND

• 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.

  PMID: 26053591 BACKGROUND

• 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.

  PMID: 25947100 BACKGROUND

• 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.

  PMID: 29408586 BACKGROUND

• 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.

  PMID: 26372360 BACKGROUND

• 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.

  PMID: 31888529 BACKGROUND

• 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.

  PMID: 18760232 BACKGROUND

• 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.

  PMID: 31682786 BACKGROUND

• 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.

  PMID: 29447448 BACKGROUND

• 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.

  PMID: 34571210 BACKGROUND

• 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.

  PMID: 2084735 BACKGROUND

MeSH Terms

Interventions

Audiovisual Aids

Intervention Hierarchy (Ancestors)

Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Nandini Raghuraman, MD, MS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: January 4, 2023
• Study Start: March 20, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 1, 2023
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)