Fetal 3D Avatar Creation for Pregnant Women

Evaluation of Fetal Realization Service Using Fetal 3D Avatar Creation and Health Care Application for Pregnant Women

• Pregnant women can intuitively check the shape and development of the fetus through the 3D avatar that reflects the characteristics of the fetus. Through a survey on VR fetal experience content and 3D fetal avatar service, the satisfaction of pregnant women/guardians, the bond between the fetus and the mother, and Assess the degree of maternal anxiety.
• Evaluate whether it can be helpful in prenatal monitoring of pregnant women through the use of maternity health management applications, and improve understanding of fetal growth and development.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy; Virtual Reality
• Intervention / Treatment: Other: use pregnancy management application

Detailed Description

• This study is an extension of the prospective pilot study conducted in 2020 under the title of "Development of 3D fetal avatar generation technology and fetal experience service technology reflecting the characteristics of pregnant women". In a previous study, about 80% of the mothers who responded to the questionnaire about the similarity of the avatar's fetal face gave a positive answer. Therefore, the developed 3D avatar fetal feeling technology is expected to have a positive effect on the intimacy between the mother and the fetus. want to analyze Pre-developed VR technology is provided through randomization to mothers who have agreed to participate in the study. In addition, objective comparison of prenatal care indicators is provided to mothers who wish to participate in this study by providing a prenatal management application that can comprehensively manage blood pressure, blood sugar, diet, exercise, maternal weight, medications, and expected fetal weight. We intend to evaluate the evaluation and maternal satisfaction.
• If technology and services for simulating a fetus with a 3D fetal avatar are provided, mothers can obtain information such as the face and developmental status of the fetus specialized for their fetus through the 3D fetal avatar. In addition, providing a fetal heart rate simulation linked to the fetal heart sound improves the bond between the mother and the fetus, which can have a positive effect on health, as well as reducing depression during pregnancy and postpartum.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeong-gi Do
    • Seongnam-si, Gyeong-gi Do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women receiving outpatient treatment at Seoul National University Bundang Hospital and pregnant women in the obstetrics and gynecology ward who wish to participate in this study

Exclusion Criteria:

• If Pregnant women refuse to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Participants who received three dimensional ultrasound with pregnancy application	Other: use pregnancy management application; Pregnant women who used pregnancy management application, which tells patients what she need to know during pregnancy, when to perform tests, and what precautions to take for your baby.
Placebo Comparator: Arm 2; Participants who received three dimensional ultrasound without pregnancy management application	Other: use pregnancy management application; Pregnant women who used pregnancy management application, which tells patients what she need to know during pregnancy, when to perform tests, and what precautions to take for your baby.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes after using the pregnant woman application	After 3D ultrasonography, at least 1 month later, a questionnaire about bonding between mother and fetus/maternal depression/health management is conducted.	1 month after examination

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B-2106/688-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to disclose the records of mothers participating in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No