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

Pregnancy, High Risk Clinical Trial

— Birthly  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783480
• Other study ID #: 848373
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, High Risk

Intervention

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.
• Standard of care
Subjects will participate in childbirth education at their own discretion.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Difference in intention to breastfeed	Intention to breastfeed prior to delivery	at 34 to 40 weeks gestational age
Secondary	Difference in breastfeeding rates at discharge after delivery		time of discharge from hospital after delivery
Secondary	Difference in breastfeeding rates postpartum		4-6 weeks postpartum
Secondary	Difference in contraceptive uptake at discharge from hospital		at time of discharge from hospital after delivery, on average 1-3 days postpartum
Secondary	Difference in contraceptive uptake postpartum		4-6 weeks postpartum
Secondary	Mode of delivery		delivery
Secondary	Number of participants with hypertensive disorders of pregnancy		delivery through 4-6 weeks postpartum
Secondary	Number of participants with maternal readmission		delivery through 4-6 weeks postpartum
Secondary	Number of participants who have Preterm birth		Time of delivery
Secondary	Difference in APGAR scores		Time of birth
Secondary	Number of infants with a need for neonatal respiratory support outside the delivery room		Time of birth
Secondary	Number of infants with a NICU admission		Time of birth