Skip to main content
OpenTrials
Completed

NCT Number: NCT04540458

3D Maternal Fetal Bonding

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maternal-Fetal Relations Maternal Behavior Paternal Behavior

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68178, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age - Female 19-45 years of age; Male > 19 years of age
  • Currently pregnant (< 32 weeks gestation)
  • Have normal 20-week ultrasound

Exclusion criteria

  • Having received more than 3 ultrasounds prior to study
  • Medical need for additional ultrasounds
  • Multiple fetuses
  • > 31 weeks gestation

Treatment and study plan

3D printed model

Other

Mother or Mother/Father is given 3D printed model of fetus' face

Placebo

Other

Mother or Mother/Father is given a picture of 3D ultrasound of fetus

Primary outcomes

  1. Maternal Antenatal Attachment Scale (MAAS)

    Time frame: 5 minutes

    The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)

  2. Paternal Antenatal Attachment Scale (PAAS)

    Time frame: 5 minutes

    The PAAS is a 16 item questionnaire measuring paternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)

  3. Maternal anxiety

    Time frame: 3 minutes

    7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered

  4. Paternal depression

    Time frame: 3 minutes

    9-question Patient Health Questionnaire (PHQ-9) will be administered

  5. Maternal depression

    Time frame: 3 minutes

    9-question Patient Health Questionnaire (PHQ-9) will be administered

  6. Paternal anxiety

    Time frame: 3 minutes

    7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered

  7. Maternal stress

    Time frame: 3 minutes

    11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2020
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.