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

Study Overview
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Brief Summary
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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.

Official Title
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Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care: An RCT

Conditions
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Pregnancy, High Risk

Intervention / Treatment
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* Other: Birthly
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Birthly plus standard of care<br>Women will receive a code to sign up for childbirth education classes through the Birthly platform. They will also participate in childbirth education at their own discretion. | Other: Birthly<br>* 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.<br>|
| Placebo Comparator: Standard of Care<br>Women will not receive a code for the 3 Birthly courses. They will participate in childbirth education at their own discretion. | Other: Standard of care<br>* Subjects will participate in childbirth education at their own discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 of enrollment to 34-40 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | one-time score at 4-6 weeks postpartum | 
| Difference in intention to breastfeed | Intention to breastfeed prior to delivery | at 34 to 40 weeks gestational age | 
| Difference in breastfeeding rates at discharge after delivery |  | time of discharge from hospital after delivery | 
| Difference in breastfeeding rates postpartum |  | 4-6 weeks postpartum | 
| Difference in contraceptive uptake at discharge from hospital |  | at time of discharge from hospital after delivery, on average 1-3 days postpartum | 
| Difference in contraceptive uptake postpartum |  | 4-6 weeks postpartum | 
| Mode of delivery |  | delivery | 
| Number of participants with hypertensive disorders of pregnancy |  | delivery through 4-6 weeks postpartum | 
| Number of participants with maternal readmission |  | delivery through 4-6 weeks postpartum | 
| Number of participants who have Preterm birth |  | Time of delivery | 
| Difference in APGAR scores |  | Time of birth | 
| Number of infants with a need for neonatal respiratory support outside the delivery room |  | Time of birth | 
| Number of infants with a NICU admission |  | Time of birth |