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Completed

NCT Number: NCT03225885

Counseling for Prematurity Using a Multimedia Education Tool

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

About this study

Approximately 500,000 infants are born prematurely in the United States every year. Premature birth prior to 27 weeks gestation currently accounts for approximately 40% of infant mortality within the United States. When compared to full term infants, premature infants have a higher risk of physical or cognitive impairment and prematurity care accounts for over 26 billion dollars annually. Parents of premature infants are placed under significant emotional, financial, and personal stress. However, parental education about prematurity is often not evidenced based, varies significantly between OB and Neonatology providers, and lacks educational aids to help parents comprehend the information provided.

Several medical societies (American Academy of Pediatrics (AAP), American Congress of Obstetrics and Gynecology (ACOG), National Institute of Child Health and Human Development (NICHD)) and parental advocates have voiced concern that the current practice is sub-optimal. Several studies have looked at this challenging situation from the family's perspective and have shown that parents find this counseling to be helpful but rarely reassuring and often stressful. Cognitive science research has recommended the use of multimedia information to simultaneously use both text and visual cognitive channels to improve information uptake and retention. Policy statements from the AAP, ACOG, and NICHD have all emphasized the importance of improving the prenatal counseling process to give our parents the most information possible so that they can make the best choices possible for their vulnerable infant.

Potential study participants will be identified after hospitalization at Froedtert Hospital for premature labor. As per current clinical practice all mothers and their support person will have a neonatology consult requested by the obstetrician. These potential participants will be screened for eligibility in the study. Mothers and their support person will then be consented for participation and will be randomized to receive either verbal counseling with printed gestational age handout or verbal counseling with the multimedia information regarding prematurity. Participation of the pregnant woman's support person will be allowed by not required. If both mother and support person consent to participate, the support person will be will be assigned the same group as the mother. Participants will take a baseline STAI (State-Trait Anxiety Inventory) at time of randomization. After prenatal counseling has been completed by a neonatal provider (neonatology attending or fellow) the participants will be provided the validated questionnaire (previously developed) to assess their knowledge of prematurity based on the AAP recommended information for parents anticipating a premature birth. Participants will also retake the STAI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Multimedia Information

Other

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

Printed handout

Other

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

Primary outcomes

  1. Overall knowledge of prematurity

    Time frame: within 24 hours of verbal counseling session

    Average of overall knowledge score

Secondary outcomes

  1. Gestational age sub-group knowledge scores

    Time frame: within 24 hours of verbal counseling session

    Comparison of average overall knowledge scores within gestational age groups 22-24 weeks and 25-29 weeks and 30-33 weeks gestation.

  2. Sub-domain knowledge scores

    Time frame: within 24 hours of verbal counseling session

    Comparison of knowledge scores between groups for sub-domains of short-term outcomes, long-term outcomes, numerical information, and treatments

  3. Anxiety

    Time frame: within 24 hours of verbal counseling

    Comparison of change in participant anxiety as assessed by STAI

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • AMAG Pharmaceuticals, Inc.
  • Children's National Research Institute
  • Marquette University

Registry information

Official study title

Effectiveness of Prenatal Counseling for Prematurity Using a Supplementary Multimedia Parent Education Tool

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2017
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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