Premature BirthNCT03225885
Counseling for Prematurity Using a Multimedia Education Tool
A study testing Multimedia Information and Printed Handout in people with Premature Birth and Counseling, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Birth, Counseling, Decision Making
- What is being tested?
- Multimedia Information and Printed Handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 25 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Premature Birth, Counseling, Decision Making, Prenatal Care, Infant, Premature, Resuscitation
- Being tested
- Multimedia Information, Printed Handout
- Keywords
- gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation
- Medical subject headings
- Premature Birth, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia InformationOther
Is a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization.
Printed HandoutOther
Printed Handout is a gestational age specific handout that addresses resuscitation and prematurity information.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Multimedia Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall knowledge of prematurity
Average of overall knowledge score
Measured: within 24 hours of verbal counseling session
Secondary outcomes (3)
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.
Measured: within 24 hours of verbal counseling session
Sub-domain knowledge scores
Comparison of knowledge scores between groups for sub-domains of short-term outcomes, long-term outcomes, numerical information, and treatments
Measured: within 24 hours of verbal counseling session
Anxiety
Comparison of change in participant anxiety as assessed by STAI
Measured: within 24 hours of verbal counseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Dec 2017
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University, Children's National Research Institute, AMAG Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Mir A Basir, Medical College of Wisconsin
- Investigators
- Mir A Basir, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225885
- Sponsor's protocol ID
- PRO00028712
- Status last verified
- Feb 2019
- First submitted
- 20 Jul 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
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.
PubMed 26324869Raju 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.
PubMed 24785861Muthusamy 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.
PubMed 22492766Paivio A. Dual coding theory: Retrospect and current status. Can J Psychol. 45(3):255-87, 1991
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.
PubMed 36708966
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prenatal Counseling for Prematurity Using a Supplementary Multimedia Parent Education Tool
- ClinicalTrials.gov ID
- NCT03225885
- Acronym / sponsor ID
- PRO00028712
- Conditions
- Premature Birth, Counseling, Decision Making, Prenatal Care, Infant, Premature, Resuscitation
- Keywords
- gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Marquette University, Children's National Research Institute, AMAG Pharmaceuticals, Inc.
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Printed Handout | Active comparator | Other: Printed HandoutParticipants 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. |
| Multimedia Information | Experimental | Other: Multimedia InformationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia InformationIs a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization. | Other | Multimedia Information |
| Printed HandoutPrinted Handout is a gestational age specific handout that addresses resuscitation and prematurity information. | Other | Printed Handout |
Primary outcome
Overall knowledge of prematurity
Time frame: within 24 hours of verbal counseling session
Average of overall knowledge score
3 secondary outcomes
Gestational age sub-group knowledge scores
Time frame: within 24 hours of verbal counseling session
Sub-domain knowledge scores
Time frame: within 24 hours of verbal counseling session
Anxiety
Time frame: within 24 hours of verbal counseling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 26324869Cummings 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.
- Background: PubMed 24785861Raju 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.
- Background: PubMed 22492766Muthusamy 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.
- BackgroundPaivio A. Dual coding theory: Retrospect and current status. Can J Psychol. 45(3):255-87, 1991
- Derived from this study: PubMed 36708966Rau 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mir A Basir, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia Information and Printed Handout in people with Premature Birth and Counseling, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall knowledge of prematurity (time frame: within 24 hours of verbal counseling session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225885, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.