Clinical trial NCT04783480: Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care
Official title: Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in PrAS score
timeFrame: time of enrollment to 34-40 weeks gestation
Secondary outcomes:
measure: Difference in healthcare utilization
timeFrame: time of enrollment through 6-week postpartum
measure: Difference in Edinburgh Postnatal Depression Scale
timeFrame: one-time score at 4-6 weeks postpartum
measure: Difference in intention to breastfeed
timeFrame: at 34 to 40 weeks gestational age
measure: Difference in breastfeeding rates at discharge after delivery
timeFrame: time of discharge from hospital after delivery
measure: Difference in breastfeeding rates postpartum
timeFrame: 4-6 weeks postpartum
measure: Difference in contraceptive uptake at discharge from hospital
timeFrame: at time of discharge from hospital after delivery, on average 1-3 days postpartum
measure: Difference in contraceptive uptake postpartum
timeFrame: 4-6 weeks postpartum
measure: Mode of delivery
timeFrame: delivery
measure: Number of participants with hypertensive disorders of pregnancy
timeFrame: delivery through 4-6 weeks postpartum
measure: Number of participants with maternal readmission
timeFrame: delivery through 4-6 weeks postpartum
measure: Number of participants who have Preterm birth
timeFrame: Time of delivery
measure: Difference in APGAR scores
timeFrame: Time of birth
measure: Number of infants with a need for neonatal respiratory support outside the delivery room
timeFrame: Time of birth
measure: Number of infants with a NICU admission
timeFrame: Time of birth
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: