NCT04093492

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. The objective is to test the efficacy of the Preemie Prep for Parents (P3) intervention on prematurity knowledge and preparedness for decision making. Participants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the P3 intervention, or access to electronic ACOG handouts (active control). Any participating partners are assigned to the same arm as their pregnant partner. The participants in the P3 group will then receive a schedule of automated text messages, with video links, up to twice a day. These videos and messages are based on information relevant to their gestational age. At study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. As pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. These questionnaires will include Prematurity Knowledge Questionnaires (specific to their gestational age), a Preparation for Decision Making scale, and an anxiety measure. At study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the Educational-Aid Questionnaire.

Conditions

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

Interventions

Type	Name	Description
OTHER	Preemie Prep for Parents (P3) Outpatient Mobile Intervention	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.
OTHER	ACOG links	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.

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-09-01
• Completion: 2022-01-31
• First posted: 2019-09-18
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

1 site across 1 country: United States