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

Medical College of Wisconsin

Status: Completed

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

Treatments: Other: Preemie Prep for Parents (P3) Outpatient Mobile Intervention; Other: ACOG links

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04093492

R21HD092664 (U.S. NIH Grant/Contract)

PRO00033902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Preemie Prep for Parents (P3) Outpatient Mobile Intervention

Experimental group

Description:

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.

Treatment:

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

ACOG links

Active Comparator group

Description:

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.

Treatment:

Other: ACOG links