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

NCT ID: NCT04783480

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy, High Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Birthly

Intervention Type OTHER

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 Care

Women will not receive a code for the 3 Birthly courses. They will participate in childbirth education at their own discretion.

Group Type PLACEBO_COMPARATOR

Standard of care

Intervention Type OTHER

Subjects will participate in childbirth education at their own discretion.

Interventions

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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.

Intervention Type OTHER

Standard of care

Subjects will participate in childbirth education at their own discretion.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37054807 (View on PubMed)

Other Identifiers

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848373

Identifier Type: -

Identifier Source: org_study_id

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