N/A
N=175
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
Premature Birth · Decision Making · Prenatal Care · Resuscitation · Infant, Premature
Bottom Line
View on ClinicalTrials.gov: NCT04093492 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Parent Prematurity Knowledge Questionnaire — 30.3; 22.8; 29.3; 25.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preemie Prep for Parents (P3) Outpatient Mobile Intervention (Other); ACOG links (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parent Prematurity Knowledge Questionnaire |
25.8; 21.3; 24.2; 20.5 | — |
| PRIMARY Parent Prematurity Knowledge Questionnaire |
25.8; 21.3; 24.2; 20.5 | — |
| PRIMARY Parent Prematurity Knowledge Questionnaire |
25.8; 21.3; 24.2; 20.5 | — |
| PRIMARY Preparation for Decision Making Scale |
68.9; 54.2; 69.3; 63.6 | — |
| PRIMARY Preparation for Decision Making Scale |
68.9; 54.2; 69.3; 63.6 | — |
| PRIMARY Preparation for Decision Making Scale |
68.9; 54.2; 69.3; 63.6 | — |
| SECONDARY Anxiety |
53.5; 55.5; 50.9; 53.0 | — |
| SECONDARY Anxiety |
53.5; 55.5; 50.9; 53.0 | — |
| SECONDARY Anxiety |
53.5; 55.5; 50.9; 53.0 | — |
| SECONDARY Anxiety |
53.5; 55.5; 50.9; 53.0 | — |
| SECONDARY Decision Self-Efficacy |
89.3; 85.8; 86.8; 86.8 | — |
| SECONDARY Decision Self-Efficacy |
89.3; 85.8; 86.8; 86.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pregnancies with known significant birth defects.
Data sourced from ClinicalTrials.gov (NCT04093492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.