Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

NCT04093492 | Completed Results

• 2 other identifiers: PRO00033902R21HD092664
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.

Conditions

Premature Birth; Decision Making; Prenatal Care; Resuscitation; Infant, Premature

Keywords

gestational age; multi-media; mobile application; anxiety; clinical trial; random allocation

Outcome Measures

Primary Outcomes (6)

• Parent Prematurity Knowledge Questionnaire

  Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 25 weeks the questionnaire has 38 items. Therefore the range of scores is from 0-38, with higher scores indicating greater knowledge.

  Assessed at participant's 25th week of pregnancy.

• Parent Prematurity Knowledge Questionnaire

  Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 30 weeks the questionnaire has 35 items. Therefore the range of scores is from 0-35, with higher scores indicating greater knowledge.

  Assessed at participant's 30th week of pregnancy.

• Parent Prematurity Knowledge Questionnaire

  Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items. Therefore the range of scores is from 0-30, with higher scores indicating greater knowledge.

  Assessed at participant's 34th week of pregnancy.

• Preparation for Decision Making Scale

  Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.

  Assessed at participant's 25th week of pregnancy.

• Preparation for Decision Making Scale

  Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.

  Assessed at participant's 30th week of pregnancy.

• Preparation for Decision Making Scale

  Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.

  Assessed at participant's 34th week of pregnancy.

Secondary Outcomes (6)

• Anxiety

  Assessed at baseline

• Anxiety

  Assessed at participant's 25th week of pregnancy.

• Anxiety

  Assessed at participant's 30th week of pregnancy.

• Anxiety

  Assessed at participant's 34th week of pregnancy.

• Decision Self-Efficacy

  Assessed at baseline

Study Arms (2)

Preemie Prep for Parents (P3) Outpatient Mobile Intervention

EXPERIMENTAL

The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.

Other: Preemie Prep for Parents (P3) Outpatient Mobile Intervention

ACOG links

ACTIVE COMPARATOR

Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.

Other: ACOG links

Interventions

Preemie Prep for Parents (P3) Outpatient Mobile Intervention OTHER

The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.

Preemie Prep for Parents (P3) Outpatient Mobile Intervention

ACOG links OTHER

Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.

ACOG links

Eligibility Criteria

• Gender Eligibility Details: Gender is a de facto criteria of inclusion, in that we will first be recruiting pregnant women. However, her partner or support person, should they wish to participate, may be of any gender.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman or her partner
• At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications.
• Gestational age of 16-21 weeks at recruitment.
• Owns a smartphone.
• Able to speak English

You may not qualify if:

• Pregnancies with known significant birth defects.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Basir MA, McDonnell SM, Brazauskas R, Kim UO, Ahamed SI, McIntosh JJ, Pizur-Barnekow K, Pitt MB, Kruper A, Leuthner SR, Flynn KE. Effect of fathers in Preemie Prep for Parents (P3) program on couple's preterm birth preparedness. Patient Educ Couns. 2025 Mar;132:108599. doi: 10.1016/j.pec.2024.108599. Epub 2024 Dec 4.

  PMID: 39647248 DERIVED

• McDonnell SM, Flynn KE, McIntosh JJ, Brazauskas R, Kim UO, Ahamed SI, Basir MA. Video Education in Early Pregnancy and Parent Knowledge of Neonatal Resuscitation Options: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2344645. doi: 10.1001/jamanetworkopen.2023.44645.

  PMID: 38010656 DERIVED

• Flynn KE, McDonnell SM, Brazauskas R, Ahamed SI, McIntosh JJ, Pitt MB, Pizur-Barnekow K, Kim UO, Kruper A, Leuthner SR, Basir MA. Smartphone-Based Video Antenatal Preterm Birth Education: The Preemie Prep for Parents Randomized Clinical Trial. JAMA Pediatr. 2023 Jul 31;177(9):921-9. doi: 10.1001/jamapediatrics.2023.1586. Online ahead of print.

  PMID: 37523163 DERIVED

MeSH Terms

Conditions

Premature Birth; Anxiety Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Mir A Basir
• Organization: Medical College of Wisconsin

mbasir@mcw.edu

414-266-6820

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 18, 2019
• Study Start: February 3, 2020
• Primary Completion: September 1, 2021
• Study Completion: January 31, 2022
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)