Clinical trial NCT04093492: Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
Official title: Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Decision Making
Prenatal Care
Resuscitation
Infant, Premature
Keywords: gestational age
multi-media
mobile application
anxiety
clinical trial
random allocation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-09-18
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Parent Prematurity Knowledge Questionnaire
timeFrame: Assessed at participant's 25th week of pregnancy.
measure: Parent Prematurity Knowledge Questionnaire
timeFrame: Assessed at participant's 30th week of pregnancy.
measure: Parent Prematurity Knowledge Questionnaire
timeFrame: Assessed at participant's 34th week of pregnancy.
measure: Preparation for Decision Making Scale
timeFrame: Assessed at participant's 25th week of pregnancy.
measure: Preparation for Decision Making Scale
timeFrame: Assessed at participant's 30th week of pregnancy.
measure: Preparation for Decision Making Scale
timeFrame: Assessed at participant's 34th week of pregnancy.
Secondary outcomes:
measure: Anxiety
timeFrame: Assessed at baseline
measure: Anxiety
timeFrame: Assessed at participant's 25th week of pregnancy.
measure: Anxiety
timeFrame: Assessed at participant's 30th week of pregnancy.
measure: Anxiety
timeFrame: Assessed at participant's 34th week of pregnancy.
measure: Decision Self-Efficacy
timeFrame: Assessed at baseline
measure: Decision Self-Efficacy
timeFrame: Assessed at 34 weeks of pregnancy
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
References: