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

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

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 Overview

• Status: Completed
• Conditions: Pregnancy, High Risk
• Intervention / Treatment: Other: Birthly; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Birthly plus standard of care; 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; 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.
Placebo Comparator: Standard of Care; 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; Subjects will participate in childbirth education at their own discretion.

What is the study measuring?

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
Mode of delivery		delivery
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
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 848373

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No