Premature Birth Clinical Trial
Official title:
Effectiveness of Prenatal Counseling for Prematurity Using a Supplementary Multimedia Parent 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.
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.
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