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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04783480
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.6
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, High Risk	Other: Birthly; Other: Standard of care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care: An RCT
• Actual Study Start Date: Apr 12, 2021
• Actual Primary Completion Date: Jun 1, 2022
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Birthly plus standard of care 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; 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.
Placebo Comparator: Standard of Care 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; Subjects will participate in childbirth education at their own discretion.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Difference in intention to breastfeed [at 34 to 40 weeks gestational age]

   Intention to breastfeed prior to delivery

4. Difference in breastfeeding rates at discharge after delivery [time of discharge from hospital after delivery]

5. Difference in breastfeeding rates postpartum [4-6 weeks postpartum]

6. Difference in contraceptive uptake at discharge from hospital [at time of discharge from hospital after delivery, on average 1-3 days postpartum]

7. Difference in contraceptive uptake postpartum [4-6 weeks postpartum]

8. Mode of delivery [delivery]

9. Number of participants with hypertensive disorders of pregnancy [delivery through 4-6 weeks postpartum]

10. Number of participants with maternal readmission [delivery through 4-6 weeks postpartum]

11. Number of participants who have Preterm birth [Time of delivery]

12. Difference in APGAR scores [Time of birth]

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

14. Number of infants with a NICU admission [Time of birth]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04783480
• Other Study ID Numbers: 848373
• First Posted: Mar 5, 2021
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 18, 2022