Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care

University of Pennsylvania90 enrolled

Overview

A pilot randomized, controlled trial comparing Birthly, (an online platform for live group prenatal classes taught by childbirth educators, nurses, and lactation consultants) plus standard prenatal care versus standard prenatal care alone among women with high risk pregnancies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pregnancy, High Risk

Interventions

BirthlyOTHER

Women will receive a code to sign up for 3 free interactive childbirth education classes through the Birthly platform. They will be enrolled in 3 courses: Prenatal Education, Childcare and Breastfeeding. They will be encouraged to complete all courses prior to 36 weeks gestational age.

Standard of careOTHER

Subjects will participate in childbirth education at their own discretion.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women over 18 * Willing and stable to give consent * English-speaking * Have access to high-speed internet available on a computer or mobile device * Nulliparous women have a confirmed single, live intrauterine gestation and are \<20 weeks gestational age at their prenatal visit * Women without indications for a scheduled cesarean delivery at the time of their index prenatal visit * Women who have a high-risk pregnancy, as defined by all maternal conditions including hypertension, diabetes, auto-immune disorders, seizure disorder, substance use, etc * Agree to participation in Birthly * Obtaining prenatal care in the University of Pennsylvania Health System Exclusion Criteria: * Women who do not speak at least conversational English * Women without internet access * Multiparous women * Women receiving group prenatal care

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in PrAS score

To determine if access to an online comprehensive platform for prenatal education and childbirth courses decreases pregnancy anxiety as measured by the Pregnancy-Related Anxiety Scale (PrAS) in nulliparous women with high risk pregnancies compared to usual prenatal care. The primary study endpoint will be a 15% reduction in PrAS score from 64 to 55 with a SD of 15.22.

Time frame: time of enrollment to 34-40 weeks gestation

Secondary Outcomes

Difference in healthcare utilization

Measured by the number of unscheduled visits to the obstetrical triage unit or ED, urgent office visits, and triage telephone encounters during pregnancy and in the 6-week postpartum period

Time frame: time of enrollment through 6-week postpartum

Difference in Edinburgh Postnatal Depression Scale

The scoring scale is 1 to 30, with a higher score indicating a worse outcome

Time frame: one-time score at 4-6 weeks postpartum

Difference in intention to breastfeed

Intention to breastfeed prior to delivery

Time frame: at 34 to 40 weeks gestational age

Difference in breastfeeding rates at discharge after delivery

Time frame: time of discharge from hospital after delivery

Difference in breastfeeding rates postpartum

Time frame: 4-6 weeks postpartum

Difference in contraceptive uptake at discharge from hospital

Time frame: at time of discharge from hospital after delivery, on average 1-3 days postpartum

Data from ClinicalTrials.gov

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