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OpenTrials
Completed

NCT Number: NCT04783480

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

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.

Completed

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Key information

Conditions

Pregnancy, High Risk

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard of care

Other

Subjects will participate in childbirth education at their own discretion.

Primary outcomes

  1. 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

  1. Difference in healthcare utilization

    Time frame: 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

  2. Difference in Edinburgh Postnatal Depression Scale

    Time frame: one-time score at 4-6 weeks postpartum

    The scoring scale is 1 to 30, with a higher score indicating a worse outcome

  3. Difference in intention to breastfeed

    Time frame: at 34 to 40 weeks gestational age

    Intention to breastfeed prior to delivery

  4. Difference in breastfeeding rates at discharge after delivery

    Time frame: time of discharge from hospital after delivery

  5. Difference in breastfeeding rates postpartum

    Time frame: 4-6 weeks postpartum

  6. Difference in contraceptive uptake at discharge from hospital

    Time frame: at time of discharge from hospital after delivery, on average 1-3 days postpartum

  7. Difference in contraceptive uptake postpartum

    Time frame: 4-6 weeks postpartum

  8. Mode of delivery

    Time frame: delivery

  9. Number of participants with hypertensive disorders of pregnancy

    Time frame: delivery through 4-6 weeks postpartum

  10. Number of participants with maternal readmission

    Time frame: delivery through 4-6 weeks postpartum

  11. Number of participants who have Preterm birth

    Time frame: Time of delivery

  12. Difference in APGAR scores

    Time frame: Time of birth

  13. Number of infants with a need for neonatal respiratory support outside the delivery room

    Time frame: Time of birth

  14. Number of infants with a NICU admission

    Time frame: Time of birth

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: Birthly

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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