NCT03200925

Brief Summary

The main purpose of this study is to determine the effect of prenatal video education on pregnant women's intention to practice and actual practice of skin to skin contact (SSC) after birth. This study hypothesizes that education in video format will increase patients knowledge about skin to skin in a way that will make them consider participating in skin to skin immediately after birth. Therefore the end point for this study is intention to participate in SCC measured by a single questionnaire item "Do you plan on participating in skin to skin (or kangaroo care) immediately after birth?" Our secondary end-point will measure whether or not the patient was able to participate in skin to skin within five minutes of delivery. All study participants will complete a short survey about their intention of practicing skin to skin after birth upon admission for delivery. Half of the study participants will only complete the brief survey. The other half of study participants will then watch a short video about skin to skin and complete one follow up question regarding their intention to practice skin to skin at the time of delivery. All patients will be followed until after delivery to determine if they were able to participate in skin to skin after delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 22, 2019

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

June 25, 2017

Results QC Date

January 18, 2019

Last Update Submit

July 20, 2019

Conditions

Keywords

videoskin-to-skinkangaroo careprenatal education

Outcome Measures

Primary Outcomes (2)

  • Intention to Practice Skin-to-skin Contact After Birth

    Both groups will be asked a short survey at the time of admission: * their intention to practice skin to skin at the time of delivery * if they participated in skin to skin in a previous pregnancy * if they had any formal education about skin to skin * if they did have formal education was it either * a.) Provided at a prenatal appointment * b.) A formal class led by either a nurse or a lactation consultant Group B will watch a short video about skin-to-skin contact and will be then reasked a question regarding their intention to practice skin-to-skin contact after birth. This information will allow us to determine if video education impacts the intention to practice skin-to-skin contact after birth.

    1 day

  • Actual Practice of Skin-to-skin Contact After Birth

    For both video and non-video groups, skin to skin duration (minutes) after delivery will be calculated. The time in minutes from delivery to initiation of skin to skin contact is also collected. This information will allow us to determine if video education impacts the actual practice of skin-to-skin contact after birth.

    1 week

Study Arms (2)

Group A - no video group

NO INTERVENTION

Group A will be asked a short survey: * their intention to practice skin to skin at the time of delivery * if they participated in skin to skin in a previous pregnancy * if they had any formal education about skin to skin * if they did have formal education was it either * a.) Provided at a prenatal appointment, * b.) A formal class led by either a nurse or a lactation consultant. We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).

Group B - video group

EXPERIMENTAL

Group B will be asked the same short survey as group A. The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery. We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).

Other: "Jumping into Kangaroo Care" - a video created by the Ohio Department of Health

Interventions

The video is 8 minutes and 52 seconds in length. The video discusses the benefits and logistics of Kangaroo Care from professional's perspectives and from new mother's perspectives.

Group B - video group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women at Southview Medical Center
  • Over the age of 18
  • Anticipating a vaginal delivery within one week of admission to labor and delivery
  • English speaking
  • Greater than 37 weeks gestation

You may not qualify if:

  • Not female
  • Not pregnant
  • Less than 37 weeks gestation
  • A scheduled cesarean section
  • Unstable medical status
  • Expecting an unstable baby requiring medical resuscitation
  • Under the age of 18
  • Non-English speaking requiring translation services
  • If a patient has a baby with a 5 minute APGAR less than 7 at the time of delivery or needs to proceed to the operating room for cesarean delivery, the patient would not be included in data collection regarding skin to skin at the time of delivery. For this group, only intention would be measured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southview Medical Center

Centerville, Ohio, 45459, United States

Location

Related Publications (13)

  • Rosen IM, Krueger MV, Carney LM, Graham JA. Prenatal breastfeeding education and breastfeeding outcomes. MCN Am J Matern Child Nurs. 2008 Sep-Oct;33(5):315-9. doi: 10.1097/01.NMC.0000334900.22215.ec.

    PMID: 18758336BACKGROUND
  • Burgio MA, Lagana AS, Sicilia A, Prosperi Porta R, Porpora MG, Ban Frangez H, DI Venti G, Triolo O. Breastfeeding Education: Where Are We Going? A Systematic Review Article. Iran J Public Health. 2016 Aug;45(8):970-977.

    PMID: 27928522BACKGROUND
  • Guise JM, Palda V, Westhoff C, Chan BK, Helfand M, Lieu TA; U.S. Preventive Services Task Force. The effectiveness of primary care-based interventions to promote breastfeeding: systematic evidence review and meta-analysis for the US Preventive Services Task Force. Ann Fam Med. 2003 Jul-Aug;1(2):70-8. doi: 10.1370/afm.56.

    PMID: 15040435BACKGROUND
  • Baby-Friendly USA. "Guidelines and Evaluation Criteria for Facilities Seeking Baby-Friendly Designation." Albany, NY: Baby-Friendly USA. 2016

    BACKGROUND
  • Charpak N, Ruiz JG. Latin American Clinical Epidemiology Network Series - Paper 9: The Kangaroo Mother Care Method: from scientific evidence generated in Colombia to worldwide practice. J Clin Epidemiol. 2017 Jun;86:125-128. doi: 10.1016/j.jclinepi.2016.05.019. Epub 2016 Oct 17.

    PMID: 27765653BACKGROUND
  • Vila-Candel R, Duke K, Soriano-Vidal FJ, Castro-Sanchez E. Affect of Early Skin-to-Skin Mother-Infant Contact in the Maintenance of Exclusive Breastfeeding: Experience in a Health Department in Spain. J Hum Lact. 2018 May;34(2):304-312. doi: 10.1177/0890334416676469. Epub 2017 Jan 18.

    PMID: 28099044BACKGROUND
  • Chung M, Raman G, Trikalinos T, Lau J, Ip S. Interventions in primary care to promote breastfeeding: an evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Oct 21;149(8):565-82. doi: 10.7326/0003-4819-149-8-200810210-00009.

    PMID: 18936504BACKGROUND
  • Moore ER, Anderson GC, Bergman N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003519. doi: 10.1002/14651858.CD003519.pub2.

    PMID: 17636727BACKGROUND
  • Martinez-Galiano JM, Delgado-Rodriguez M. Influence of an education program of pregnant women on delivery. J Matern Fetal Neonatal Med. 2014 May;27(7):719-23. doi: 10.3109/14767058.2013.836486. Epub 2013 Sep 25.

    PMID: 23962180BACKGROUND
  • Krouse HJ. Video modelling to educate patients. J Adv Nurs. 2001 Mar;33(6):748-57. doi: 10.1046/j.1365-2648.2001.01716.x.

    PMID: 11298212BACKGROUND
  • Abu Abed M, Himmel W, Vormfelde S, Koschack J. Video-assisted patient education to modify behavior: a systematic review. Patient Educ Couns. 2014 Oct;97(1):16-22. doi: 10.1016/j.pec.2014.06.015. Epub 2014 Jul 5.

    PMID: 25043785BACKGROUND
  • Shealy KR, Li R, Benton-Davis S, Grummer-Strawn LM. The CDC Guide to Breastfeeding Interventions. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2005

    BACKGROUND
  • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.

    PMID: 497341BACKGROUND

Results Point of Contact

Title
Catherine Caponero, DO
Organization
Kettering Health Network

Study Officials

  • Catherine M Caponero, DO

    Kettering Health Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will not know which arm of the trial they will be apart of until after they have consented to participate
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2017

First Posted

June 27, 2017

Study Start

June 23, 2017

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

August 2, 2019

Results First Posted

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations