A Prenatal Mentalization-focused 4D Ultrasound and a Pregnancy Diary Intervention for Substance-abusing Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Prenatal depressive symptoms post-intervention at 35 gestational weeks
研究概览
简要总结
Objective: This randomized and controlled trial was aimed at exploring the effect of a new mentalization-focused 4D interactive ultrasound and a week-by-week pregnancy diary intervention with substance-abusing pregnant women.
Method: Pregnant women referred to the hospital maternity outpatient clinic from primary health care due to substance abuse were recruited to participate in a randomized and controlled study. At admission, a psychiatric nurse offered all eligible women an opportunity for participation. A written informed consent was obtained from all participants included in the study. The participants were randomized into the intervention and control groups using a computer-generated block-randomization with block size of four. A separate randomization assignment was used for women in medication-assisted treatment for opioid dependence.
The intervention group subjects were offered three mentalization-focused interactive 4D ultrasounds at 24, 30 and 34 gestational weeks and a mentalization-focused week-by-week pregnancy diary combined with three antenatal sessions and an option for one diary session after delivery. The control group received active treatment as usual in an obstetric tertiary setting.
The pregnant woman and the child were followed-up until the child was one year old. The primary outcome was prenatal maternal depressive symptoms post-intervention, and secondary outcomes were anxiety symptoms, prenatal parental mentalization, maternal-fetal attachment and substance abuse. Other outcomes were utilisation of prenatal care, perinatal outcome, neonatal withdrawal symptoms and neonatal neurobehavior, postnatal maternal depressive and anxiety symptoms, parental mentalization, experienced stress from parenting and experienced social support, and emotional connection and commitment with the baby.
The study was conducted at the hospital maternity outpatient clinic for substance-abusing pregnant women at Turku University Hospital (Finland) between October 2011 and December 2015. The registration of the trial is made retrospectively, but the research plan and outcomes are reported in this registration as they were originally documented in the research plan approved by The Joint Ethics Committee of the University of Turku and the Hospital District of Southwest Finland on 14th of June 2011.
详细描述
Objective:
The aim of this controlled trial was to explore the effect of a new mentalization-focused 4D interactive ultrasound and a week-by-week pregnancy diary intervention with substance-abusing pregnant women.
Method:
This trial was conducted at the maternity outpatient clinic for substance-abusing pregnant women at Turku University Hospital, Finland, between October 2011 and December 2015. At Turku University Hospital there is a specialized antenatal outpatient clinic for pregnant women with substance abuse problems. Pregnant women referred to this facility from primary health care due to substance abuse were invited to participate the trial.
At admission, a psychiatric nurse offered all eligible women an opportunity to participate in the randomized trial. A written informed consent was obtained from all individual participants included in the study. The participants were randomized into the intervention and control groups using a computer-generated block-randomization with block size of four, and a separate randomization assignment was used for women in medication-assisted treatment for opioid addiction. In post-intervention phase at 35 gestational weeks, all participants were compensated with a 20 euros gift card targeted to the infant's needs. The research plan was approved by The Joint Ethics Committee of the University of Turku and the Hospital District of Southwest Finland on the 14th of June 2011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women referred to the hospital maternity outpatient clinic from primary health care due to substance abuse were recruited to participate in a randomized and controlled study. The subjects were referred from primary health care due to:
- •documented or self-reported illicit drug use, misuse of prescription medication or alcohol within three years prior to or during this pregnancy,
- •and/or sum score ≥ 3 points on TWEAK alcohol screening (Russell, 1994).
- •The inclusion criteria included also:
- •pregnancy duration < 22 gestational weeks (gwks) at referral
- •singleton pregnancy.
排除标准
- 未提供
研究组 & 干预措施
Prenatal mentalization intervention
The intervention group participants were offered three mentalization-focused 4D interactive ultrasounds at 24, 30 and 34 gestational weeks and a mentalization-focused week-by-week pregnancy diary combined with three prenatal sessions and option for one session after delivery in addition to obstetric care as usual (see Prenatal obstetric treatment as usual).
干预措施: Prenatal mentalization intervention (Behavioral)
Prenatal mentalization intervention
The intervention group participants were offered three mentalization-focused 4D interactive ultrasounds at 24, 30 and 34 gestational weeks and a mentalization-focused week-by-week pregnancy diary combined with three prenatal sessions and option for one session after delivery in addition to obstetric care as usual (see Prenatal obstetric treatment as usual).
干预措施: Prenatal obstetric treatment as usual (Other)
Prenatal obstetric treatment as usual
The control group received obstetric care as usual in a tertiary setting. The comprehensive treatment as usual was conducted at the hospital antenatal outpatient clinic, including regular obstetric ultrasounds. The multidisciplinary treatment team, consisting of an obstetrician, a midwife, a social worker and a psychiatric nurse, assess and support health and psychosocial situation of the pregnant woman. The pregnant woman was referred to addiction and psychiatric treatment when needed.
干预措施: Prenatal obstetric treatment as usual (Other)
结局指标
主要结局
Prenatal depressive symptoms post-intervention at 35 gestational weeks
时间窗: Post-intervention at 35 gestational weeks
Assessment of prenatal depressive symptoms with Edinburgh Pre/Postnatal Depression Scale (EPDS); theoretical range of total scale (minimum and maximum scores) 0-30 points and lower total score indicating lower level of depressive symptoms and better outcome.
次要结局
- Prenatal anxiety symptoms post-intervention at 35 gestational weeks(Post-intervention at 35 gestational weeks)
- Maternal-fetal attachment post-intervention at 35 gestational weeks(Post-intervention at 35 gestational weeks)
- Prenatal parental mentalization post-intervention at 35 gestational weeks(Post-intervention at 35 gestational weeks)
- Prenatal maternal substance abuse (health behaviour)(From date of randomization until the date of delivery, assessed up to 42 gestational weeks)
研究者
Eeva Ekholm
Consultant, MD, PhD, Docent
Turku University Hospital