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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04093492
Study type Interventional
Source Medical College of Wisconsin
Contact
Status Completed
Phase N/A
Start date February 3, 2020
Completion date January 31, 2022

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