Prenatal Anxiety Clinical Trial
— 4D ultrasoundOfficial title:
Interactive Ultrasound Examination as Psychological Support for Pregnant Women
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - severe psychic symptoms e.g. suicidality, psychotic symptoms |
Country | Name | City | State |
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Finland | TYKS Naistenklinikka | Turku |
Lead Sponsor | Collaborator |
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Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 | |
Primary | postnatal depressive symptoms | EPDS (Edinburgh Pre/Postnatal Depression Scale) 0-30 points, cut-off for major depression is 15 points. | 4 months postpartum | |
Secondary | general anxiety | SCL-90 (Symptom Checklist) measures general anxiety. Consists of 90 questions, each question contains 4 items. Higher score correlates positively with anxiety symptoms. | At gestational week 25 and at gestational week 32-33. | |
Secondary | pregnancy related anxiety | PRAQ-R2 (Pregnancy Related Anxiety Questionaire Revised) Measures pregnancy related anxiety. Consists of 11 questions, each containing 5 items. Higher score correlates positively with pregnancy related anxiety. | At gestational week 25 and at gestational week 32-33 | |
Secondary | maternal-fetal relations | WMCI (Working Model of the Child Interview) is psychologists interview, that is a one-hour, semi-structured, exploring systematically the narrative patterns of parents' thoughts, feelings, and perceptions of their unborn baby and their emerging relationship. The scoring of the quality of parents' representations will be conducted from video recorded interviews. The quality and the content of the representations will be scored straight from the videotapes of the interviews using with the seven scales presented in the manual. The qualitative scales are richness of perceptions, openness to change, intensity of involvement, coherence, caregiving sensitivity, and acceptance. The content scales are infant difficulties and fear for the infant's safety. These scales will be scored with a Likert type scale ranging from 1 to 5. The parental representations will be classified based on the manual into three categories: balanced, disengaged, and distorted. | At gestational week 25 and 32-33 | |
Secondary | maternal-fetal attachment | MAAS (Maternal Antenatal Attachment Scale) is 19 questions containing questionaire. which focus on feelings, attitudes and behaviours towards the fetus with responses recorded on a 5 point Likert Scale. Maximum score is 95 points. High score correlates to strong attachment, low score to weak attachment. | At gestational week 25 and 32-33. | |
Secondary | maternal-fetal attachment | MPAS (Maternal Postnatal Attachment Scale) is 19 questions containing questionaire. which focus on feelings, attitudes and behaviours towards the foetus with responses recorded on a 5 point Likert Scale. Maximum score is 95 points. High score correlates to strong attachment, low score to weak attachment. | 4 months postpartum. | |
Secondary | maternal-fetal fetal relations | Parent Child Early Relational Assessment (PCERA) observation. Videotaped interplay is analysed by psychologist.
the foetus with responses recorded on a 5 point Likert Scale. Maximum score is 95 points. High score correlates to strong attachment, low score to weak attachment. |
4 months postpartum. |
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