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| Name | Class |
|---|---|
| Marquette University | OTHER |
| Children's National Research Institute | OTHER |
| AMAG Pharmaceuticals, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimedia Information | Other | Is a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall knowledge of prematurity | Average of overall knowledge score | within 24 hours of verbal counseling session |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age sub-group knowledge scores | Comparison of average overall knowledge scores within gestational age groups 22-24 weeks and 25-29 weeks and 30-33 weeks gestation. | within 24 hours of verbal counseling session |
| Sub-domain knowledge scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mir A Basir, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26324869 | Background | 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. | |
| 24785861 | 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. |
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There is no plan to share IPD.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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| Printed Handout | Other | Printed Handout is a gestational age specific handout that addresses resuscitation and prematurity information. |
|
Comparison of knowledge scores between groups for sub-domains of short-term outcomes, long-term outcomes, numerical information, and treatments
| within 24 hours of verbal counseling session |
| Anxiety | Comparison of change in participant anxiety as assessed by STAI | within 24 hours of verbal counseling |
| 22492766 | 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. |
| Background | Paivio A. Dual coding theory: Retrospect and current status. Can J Psychol. 45(3):255-87, 1991 |
| 36708966 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |