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

NCT04783480 | Completed

• 1 other identifier: 848373
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy, High Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Difference in healthcare utilization

  time of enrollment through 6-week postpartum

• Difference in Edinburgh Postnatal Depression Scale

  one-time score at 4-6 weeks postpartum

• Difference in intention to breastfeed

  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

Study Arms (2)

Birthly plus standard of care

ACTIVE COMPARATOR

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

Standard of Care

PLACEBO COMPARATOR

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

Interventions

Birthly OTHER

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.

Birthly plus standard of care

Standard of care OTHER

Subjects will participate in childbirth education at their own discretion.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who do not speak at least conversational English
• Women without internet access
• Multiparous women
• Women receiving group prenatal care

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Zafman KB, Riegel ML, Levine LD, Hamm RF. An interactive childbirth education platform to improve pregnancy-related anxiety: a randomized trial. Am J Obstet Gynecol. 2023 Jul;229(1):67.e1-67.e9. doi: 10.1016/j.ajog.2023.04.007. Epub 2023 Apr 11.

  PMID: 37054807 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 5, 2021
• Study Start: April 12, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)