Pregnancy, High Risk
Conditions
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.
Interventions
OTHERBirthly
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.
OTHERStandard of care
Subjects will participate in childbirth education at their own discretion.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Difference in intention to breastfeed | at 34 to 40 weeks gestational age | Intention to breastfeed prior to delivery |
| Difference in breastfeeding rates at discharge after delivery | time of discharge from hospital after delivery | — |
| Difference in breastfeeding rates postpartum | 4-6 weeks postpartum | — |
| 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 | — |
| 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 |
| Number of participants with hypertensive disorders of pregnancy | delivery through 4-6 weeks postpartum | — |
| Number of participants with maternal readmission | delivery through 4-6 weeks postpartum | — |
| Number of participants who have Preterm birth | Time of delivery | — |
| Difference in APGAR scores | Time of birth | — |
| Number of infants with a need for neonatal respiratory support outside the delivery room | Time of birth | — |
| Number of infants with a NICU admission | Time of birth | — |
| Mode of delivery | delivery | — |
Countries
United States
Outcome results
None listed