NCT03424642

Brief Summary

Relationship between mother and child starts to develop during pregnancy and continues after birth. Drug abuse, depression, very young or old age, weak social network, mothers´ own negative experiences from childhood's relationships and fear of birth may weaken the normal development of maternal-fetal bonding during pregnancy. Gestational weeks 24-32 are crucial in the point of maternal-fetal bonding. Ultrasound examinations during pregnancy have shown to strengthen the early relationship between mother and fetus in every trimester, to diminish mother's anxiety, to improve mothers bonding to child and to guide mother towards healthier lifestyle. Mental images awaken emotional relationship to the child. It is possible to prevent the interference of the gestational process of forming mental images and to diminish the negative effects of gestational stress to the child by intervention, that further prevents the problems of the baby's first year. Psychological intervention, that supports the interaction between mother and child, combined to gestational ultrasound examination has not investigated before in pregnant women with risk to preterm birth, depressive symptoms or other mental symptoms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

4.2 years

First QC Date

January 5, 2018

Last Update Submit

October 26, 2020

Conditions

Prenatal Anxiety

Keywords

prenatal depressionprenatal anxietyprenatal mental disordersinteractive ultrasound examinationmaternal-fetal relations

Outcome Measures

Primary Outcomes (2)

  • prenatal depressive symptoms

    EPDS (Edinburgh Pre/Postnatal depression scale). 10 questions, scale 0-30 points, cut of for major depression is 15 points.

    Gestational weeks 21-24

  • postnatal depressive symptoms

    EPDS (Edinburgh Pre/Postnatal Depression Scale) 0-30 points, cut-off for major depression is 15 points.

    4 months postpartum

Secondary Outcomes (6)

  • general anxiety

    At gestational week 25 and at gestational week 32-33.

  • pregnancy related anxiety

    At gestational week 25 and at gestational week 32-33

  • maternal-fetal relations

    At gestational week 25 and 32-33

  • maternal-fetal attachment

    At gestational week 25 and 32-33.

  • maternal-fetal attachment

    4 months postpartum.

  • +1 more secondary outcomes

Study Arms (2)

Interactive 4D-ultrasound examination

EXPERIMENTAL

Pregnant women who are randomized to 4D-ultrasound intervention group will receive additional 4D-ultrasound examinations 2-3 times between gestational weeks 25-32. Patients in this group will also receive psychologist's interview twice and fill out questionaries.

Behavioral: Interactive 4D-ultrasound examination

Control group

NO INTERVENTION

Pregnant women who are randomized to control group will receive psychologist's interview twice twice and fill out questionaires.

Interventions

Interactive 4D-ultrasound examinationBEHAVIORAL

Randomized controlled trial

Interactive 4D-ultrasound examination

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pilot study(pregnant women who are hospitalized because of risk to preterm birth): singleton pregnancy, fluent in Finnish, age over 18
  • randomized trial: EPDS 10-14 points, singleton pregnancy, fluent in Finnish, age over 18, BMI under 35

You may not qualify if:

  • severe psychic symptoms e.g. suicidality, psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TYKS Naistenklinikka

Turku, 20521, Finland

RECRUITING

Related Publications (1)

  • Pulliainen H, Sari-Ahlqvist-Bjorkroth, Ekholm E. Does interactive ultrasound intervention relieve minor depressive symptoms and increase maternal attachment in pregnancy? A protocol for a randomized controlled trial. Trials. 2022 Apr 15;23(1):313. doi: 10.1186/s13063-022-06262-4.

    PMID: 35428357DERIVED

Study Officials

  • Eeva MK Ekholm, ph d

    TYKS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrika P Pulliainen, md

CONTACT

+358445274024hpherm@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

February 7, 2018

Study Start

January 1, 2018

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)