Visual Aids for Induction of Labor RCT

NCT ID: NCT05671224

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Induced; Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard counseling

Standard induction of labor counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Visual aid counseling

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

Group Type EXPERIMENTAL

Visual aid

Intervention Type OTHER

Handout and video describing different types of induction of labor

Interventions

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Visual aid

Handout and video describing different types of induction of labor

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nandini Raghuraman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30089070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26053591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25947100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29408586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26372360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31888529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18760232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31682786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29447448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34571210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2084735 (View on PubMed)

Other Identifiers

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202301001

Identifier Type: -

Identifier Source: org_study_id

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