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

July 15, 2022 updated by: University of Pennsylvania

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
time of enrollment to 34-40 weeks gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: delivery
delivery
Difference in healthcare utilization
Time Frame: 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
time of enrollment through 6-week postpartum
Difference in Edinburgh Postnatal Depression Scale
Time Frame: one-time score at 4-6 weeks postpartum
The scoring scale is 1 to 30, with a higher score indicating a worse outcome
one-time score at 4-6 weeks postpartum
Difference in intention to breastfeed
Time Frame: at 34 to 40 weeks gestational age
Intention to breastfeed prior to delivery
at 34 to 40 weeks gestational age
Difference in breastfeeding rates at discharge after delivery
Time Frame: time of discharge from hospital after delivery
time of discharge from hospital after delivery
Difference in breastfeeding rates postpartum
Time Frame: 4-6 weeks postpartum
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
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
4-6 weeks postpartum
Number of participants with hypertensive disorders of pregnancy
Time Frame: delivery through 4-6 weeks postpartum
delivery through 4-6 weeks postpartum
Number of participants with maternal readmission
Time Frame: delivery through 4-6 weeks postpartum
delivery through 4-6 weeks postpartum
Number of participants who have Preterm birth
Time Frame: Time of delivery
Time of delivery
Difference in APGAR scores
Time Frame: Time of birth
Time of birth
Number of infants with a need for neonatal respiratory support outside the delivery room
Time Frame: Time of birth
Time of birth
Number of infants with a NICU admission
Time Frame: Time of birth
Time of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 848373

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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