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临床试验/NCT03424642
NCT03424642Unknown不适用

Interactive Ultrasound Examination as Psychological Support for Pregnant Women

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
postnatal depressive symptoms

研究概览

简要总结

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.

详细描述

Relationship between mother and child starts to develop during pregnancy and continues after birth. The basis to it consists of mental images of self and spouse and observations of the baby via ultrasound examinations and sensations of the baby's movements. Drug abuse, depression, very young or old age, weak social network, mother's own negative experiences from childhood's relationships or fear of birth may weaken the normal development of maternal-fetal attachment. Gestational weeks between 24-32 are crucial in the point of maternal-fetal bonding. Preterm birth interrupts the development of the attachment. Studies have approved that parents' psychiatric morbidity predisposes the offspring to developmental and psychological problems. It's known that parents' depression predisposes their children to behavioral- and emotional disorders.

Prenatal depression leads to postnatal depression after birth in about 10 % of pregnant women. Depressive symptoms can reflect to expectancy and to emotions towards the unborn child and affect the quality of the early interaction between mother and baby. Mothers' depressive symptoms have link to pregnancy complications and to preterm birth. Anxiety and depression during the third trimester increases the risk to preterm birth. Anxiety during pregnancy has a connection to pre-eclampsia. The problems in maternal- fetal relationship originate from pregnancy and that's why timing treatment pregnancy is important. Pregnancy is opportune time to treat mothers' physical and psychic problems because the worry about the fetus motivates.

Gestational ultrasound has shown to strengthen the bonding towards the fetus in every trimester, to diminish mothers' anxiety, to improve mothers attachment to the fetus and to guide mother towards healthier lifestyle. Psychologic intervention combined with gestational ultrasound examination has detected to strengthen the maternal-fetal interaction in depressive mothers. Mental images awaken emotional bond to the unborn child. It is possible to prevent the disturbance of the process of forming mental images and to decrease the negative impact of gestational stress with gestational ultrasound examination. Interactive ultrasound examination has not explored before in pregnant women with risk to preterm birth, depressive and other mental symptoms. By awakening and strengthening mother's mental images of fetus decreases anxiety and other psychic symptoms.

The aim of the study is to develop a documented treatment model in specialist medical care to pregnant women who suffer from mental disorders in order to strengthen the early bonding via interactive ultrasound examination. The aim of the study is to find out if the interactive ultrasound examination improves interaction between mother and baby and does it improve baby's prognosis. To find out does the interactive ultrasound improve gestational bonding to fetus. To find out does the interactive ultrasound examination diminish mother's depressive and anguish symptoms. To find out the cost co efficiency in health care visits.

Pilot study was carried out with pregnant women who are hospitalized because of risk to preterm birth. 4D-ultrasound is done once and psychologist's interview after the examination. The aim of the pilot study was to map mothers' experiences of interactive ultrasound examination and to map their needs to psychological support in addition to interactive ultrasound examination before the actual randomized trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

postnatal depressive symptoms

时间窗: 4 months postpartum

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

prenatal depressive symptoms

时间窗: Gestational weeks 21-24

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

次要结局

  • 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 attachment(4 months postpartum.)
  • maternal-fetal relations(At gestational week 25 and 32-33)
  • maternal-fetal fetal relations(4 months postpartum.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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