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

Not Applicable

Completed

• Conditions: Pregnancy, High Risk
• Interventions: Other: Standard of care; Other: Birthly

• Registration Number: NCT04783480
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-04-12
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of care	Women will not receive a code for the 3 Birthly courses. They will participate in childbirth education at their own discretion.
Birthly plus standard of care	Birthly	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.

Primary Outcome Measures

Name	Time	Method
Change in PrAS score	time of enrollment to 34-40 weeks gestation	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.

Secondary Outcome Measures

Name	Time	Method
Difference in breastfeeding rates postpartum	4-6 weeks postpartum
Mode of delivery	delivery
Difference in APGAR scores	Time of birth
Difference in intention to breastfeed	at 34 to 40 weeks gestational age	Intention to breastfeed prior to delivery
Difference in breastfeeding rates at discharge after delivery	time of discharge from hospital after delivery
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 maternal readmission	delivery through 4-6 weeks postpartum
Difference in healthcare utilization	time of enrollment through 6-week postpartum	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
Difference in Edinburgh Postnatal Depression Scale	one-time score at 4-6 weeks postpartum	The scoring scale is 1 to 30, with a higher score indicating a worse outcome
Number of participants who have Preterm birth	Time of delivery
Number of infants with a need for neonatal respiratory support outside the delivery room	Time of birth
Number of participants with hypertensive disorders of pregnancy	delivery through 4-6 weeks postpartum
Number of infants with a NICU admission	Time of birth

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States