Counseling for Prematurity Using a Multimedia Education Tool

NCT03225885 | Completed

• 1 other identifier: PRO00028712
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of prenatal counseling when verbal counseling is supplemented with a multi-media mobile application versus a written gestational age handout.

Conditions

Premature Birth; Counseling; Decision Making; Prenatal Care; Infant, Premature; Resuscitation

Keywords

gestational age; multi-media; mobile application; anxiety; clinical trial; random allocation

Outcome Measures

Primary Outcomes (1)

• Overall knowledge of prematurity

  Average of overall knowledge score

  within 24 hours of verbal counseling session

Secondary Outcomes (3)

• Gestational age sub-group knowledge scores

  within 24 hours of verbal counseling session

• Sub-domain knowledge scores

  within 24 hours of verbal counseling session

• Anxiety

  within 24 hours of verbal counseling

Study Arms (2)

Printed Handout

ACTIVE COMPARATOR

Participants in this arm will receive verbal prematurity counseling from a Neonatologist or Neonatal fellow as well as a printed gestational age specific handout about prematurity.

Other: Printed Handout

Multimedia Information

EXPERIMENTAL

Participants in this arm will receive verbal prematurity counseling from a Neonatologist or Neonatal fellow as well as have bedside access to iPad multimedia information regarding prematurity.

Other: Multimedia Information

Interventions

Multimedia Information OTHER

Is a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization.

Multimedia Information

Printed Handout OTHER

Printed Handout is a gestational age specific handout that addresses resuscitation and prematurity information.

Printed Handout

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Admitted to Labor and Delivery unit due to concerns for premature delivery, gestational age of fetus between 22 weeks 0 days and 33 weeks 6 days

You may not qualify if:

• known significant genetic abnormality or congenital anomaly that would effect survival or counseling that parents receive
• participants will be excluded from analysis if delivery occurs prior to completion of questionnaires as other sources of information become available after birth

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Marquette University: collaborator
• Children's National Research Institute: collaborator
• AMAG Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (5)

• Cummings J; COMMITTEE ON FETUS AND NEWBORN. Antenatal Counseling Regarding Resuscitation and Intensive Care Before 25 Weeks of Gestation. Pediatrics. 2015 Sep;136(3):588-95. doi: 10.1542/peds.2015-2336.

  PMID: 26324869 BACKGROUND

• Raju TNK, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014 May;123(5):1083-1096. doi: 10.1097/AOG.0000000000000243.

  PMID: 24785861 BACKGROUND

• Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.

  PMID: 22492766 BACKGROUND

• Paivio A. Dual coding theory: Retrospect and current status. Can J Psychol. 45(3):255-87, 1991

  BACKGROUND

• Rau NM, Mcintosh JJ, Flynn KE, Szabo A, Ahamed SI, Asan O, Hasan MK, Basir MA. Multimedia tablet or paper handout to supplement counseling during preterm birth hospitalization: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100875. doi: 10.1016/j.ajogmf.2023.100875. Epub 2023 Jan 26.

  PMID: 36708966 DERIVED

MeSH Terms

Conditions

Premature Birth; Anxiety Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Study Officials

• Mir A Basir, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial where participants are assigned to 1 of 2 groups for the duration of the study. One group will receive verbal counseling and a printed gestational age handout. The other group will receive verbal counseling and a bedside iPad with the multimedia information about prematurity.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: December 1, 2017
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)