Pregnancy, High RiskBirthlyNCT04783480
Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care
A study testing Birthly in people with Pregnancy, High Risk, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, High Risk
- What is being tested?
- Birthly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Women who do not speak at least conversational English
- Women without internet access
- Multiparous women
- Women receiving group prenatal care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care: An RCT
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.
- Conditions
- Pregnancy, High Risk
- Being tested
- Birthly, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BirthlyOther
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 careOther
Subjects will participate in childbirth education at their own discretion.
| Study group | Role | What they receive |
|---|---|---|
| Birthly plus standard of care | Active comparator | 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. Receives: Other: Birthly |
| Standard of Care | Placebo comparator | Women will not receive a code for the 3 Birthly courses. They will participate in childbirth education at their own discretion. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: time of enrollment to 34-40 weeks gestation
Secondary outcomes (14)
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
Measured: time of enrollment through 6-week postpartum
Difference in Edinburgh Postnatal Depression Scale
The scoring scale is 1 to 30, with a higher score indicating a worse outcome
Measured: one-time score at 4-6 weeks postpartum
Difference in intention to breastfeed
Intention to breastfeed prior to delivery
Measured: at 34 to 40 weeks gestational age
Difference in breastfeeding rates at discharge after delivery
Measured: time of discharge from hospital after delivery
Difference in breastfeeding rates postpartum
Measured: 4-6 weeks postpartum
Difference in contraceptive uptake at discharge from hospital
Measured: at time of discharge from hospital after delivery, on average 1-3 days postpartum
Difference in contraceptive uptake postpartum
Measured: 4-6 weeks postpartum
Mode of delivery
Measured: delivery
Number of participants with hypertensive disorders of pregnancy
Measured: delivery through 4-6 weeks postpartum
Number of participants with maternal readmission
Measured: delivery through 4-6 weeks postpartum
Number of participants who have Preterm birth
Measured: Time of delivery
Difference in APGAR scores
Measured: Time of birth
Number of infants with a need for neonatal respiratory support outside the delivery room
Measured: Time of birth
Number of infants with a NICU admission
Measured: Time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start12 Apr 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783480
- Sponsor's protocol ID
- 848373
- Acronym
- Birthly
- Status last verified
- Jul 2022
- First submitted
- 25 Feb 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zafman KB, Riegel ML, Levine LD, Hamm RF. An interactive childbirth education platform to improve pregnancy-related anxiety: a randomized trial. Am J Obstet Gynecol. 2023 Jul;229(1):67.e1-67.e9. doi: 10.1016/j.ajog.2023.04.007. Epub 2023 Apr 11.
PubMed 37054807
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care: An RCT
- ClinicalTrials.gov ID
- NCT04783480
- Acronym / sponsor ID
- Birthly / 848373
- Conditions
- Pregnancy, High Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Birthly plus standard of care | Active comparator | Other: BirthlyWomen 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. |
| Standard of Care | Placebo comparator | Other: Standard of careWomen will not receive a code for the 3 Birthly courses. They will participate in childbirth education at their own discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Women who do not speak at least conversational English
- Women without internet access
- Multiparous women
- Women receiving group prenatal care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BirthlyWomen 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. | Other | Birthly plus standard of care |
| Standard of careSubjects will participate in childbirth education at their own discretion. | Other | Standard of Care |
Primary outcome
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.
14 secondary outcomes
Difference in healthcare utilization
Time frame: time of enrollment through 6-week postpartum
Difference in Edinburgh Postnatal Depression Scale
Time frame: one-time score at 4-6 weeks postpartum
Difference in intention to breastfeed
Time frame: at 34 to 40 weeks gestational age
Difference in breastfeeding rates at discharge after delivery
Time frame: time of discharge from hospital after delivery
Difference in breastfeeding rates postpartum
Time frame: 4-6 weeks postpartum
Difference in contraceptive uptake at discharge from hospital
Time frame: at time of discharge from hospital after delivery, on average 1-3 days postpartum
Difference in contraceptive uptake postpartum
Time frame: 4-6 weeks postpartum
Mode of delivery
Time frame: delivery
Number of participants with hypertensive disorders of pregnancy
Time frame: delivery through 4-6 weeks postpartum
Number of participants with maternal readmission
Time frame: delivery through 4-6 weeks postpartum
Number of participants who have Preterm birth
Time frame: Time of delivery
Difference in APGAR scores
Time frame: Time of birth
Number of infants with a need for neonatal respiratory support outside the delivery room
Time frame: Time of birth
Number of infants with a NICU admission
Time frame: Time of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 37054807Zafman KB, Riegel ML, Levine LD, Hamm RF. An interactive childbirth education platform to improve pregnancy-related anxiety: a randomized trial. Am J Obstet Gynecol. 2023 Jul;229(1):67.e1-67.e9. doi: 10.1016/j.ajog.2023.04.007. Epub 2023 Apr 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birthly in people with Pregnancy, High Risk, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PrAS score (time frame: time of enrollment to 34-40 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.