3D Maternal Fetal Bonding

NCT04540458 | Completed

• 1 other identifier: 1052761
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal-Fetal Relations; Paternal Behavior; Maternal Behavior

Outcome Measures

Primary Outcomes (7)

• Maternal Antenatal Attachment Scale (MAAS)

  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.)

  5 minutes

• Paternal Antenatal Attachment Scale (PAAS)

  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.)

  5 minutes

• Maternal anxiety

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

  3 minutes

• Paternal depression

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

  3 minutes

• Maternal depression

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

  3 minutes

• Paternal anxiety

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

  3 minutes

• Maternal stress

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

  3 minutes

Study Arms (2)

3D printed model

OTHER

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

Other: 3D printed model

Placebo

OTHER

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

Other: Placebo

Interventions

3D printed model OTHER

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

3D printed model

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

Study Officials

• John Cote, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: September 7, 2020
• Study Start: February 4, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)