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Clinical Trials/NCT04783480
NCT04783480CompletedNot Applicable

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

University of Pennsylvania2 sites in 1 country90 target enrollmentStarted: April 12, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
2
Primary Endpoint
Change in PrAS score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in PrAS score

Time Frame: 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 Outcomes

  • Mode of delivery(delivery)
  • Difference in APGAR scores(Time of birth)
  • Difference in breastfeeding rates postpartum(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 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)
  • Difference in Edinburgh Postnatal Depression Scale(one-time score at 4-6 weeks postpartum)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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