Depression Clinical Trial
Official title:
A Prenatal Mentalization-focused 4D Ultrasound and a Pregnancy Diary Intervention for Substance-abusing Women
Verified date | January 2018 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | December 31, 2015 |
Est. primary completion date | December 31, 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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: 1. documented or self-reported illicit drug use, misuse of prescription medication or alcohol within three years prior to or during this pregnancy, 2. and/or sum score = 3 points on TWEAK alcohol screening (Russell, 1994). The inclusion criteria included also: 3. pregnancy duration < 22 gestational weeks (gwks) at referral 4. singleton pregnancy. |
Country | Name | City | State |
---|---|---|---|
Finland | Department of Obstetrics and Gynecology and Department of Child Psychiatry, Turku University Hospital; Department of Obstetrics and Gynecology and Department of Child Psychiatry, University of Turku, Turku, Finland | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital | Academy of Finland, Foundation for Paediatric Research, Finland, Hospital District of Southwestern Finland, University of Turku |
Finland,
Boukydis CF, Treadwell MC, Delaney-Black V, Boyes K, King M, Robinson T, Sokol R. Women's responses to ultrasound examinations during routine screens in an obstetric clinic. J Ultrasound Med. 2006 Jun;25(6):721-8. — View Citation
Boukydis Z. Ultrasound consultation to reduce risk and increase resilience in pregnancy. Ann N Y Acad Sci. 2006 Dec;1094:268-71. — View Citation
Kokkevi, A., & Hartgers, C. (1995). EuropASI: European adaptation of a multidimensional assessment instrument for drug and alcohol dependence. Eur Addict Res, 1, 208-210.
Pajulo H, Pajulo M, Jussila H, Ekholm E. SUBSTANCE-ABUSING PREGNANT WOMEN: PRENATAL INTERVENTION USING ULTRASOUND CONSULTATION AND MENTALIZATION TO ENHANCE THE MOTHER-CHILD RELATIONSHIP AND REDUCE SUBSTANCE USE. Infant Ment Health J. 2016 Jul;37(4):317-34. doi: 10.1002/imhj.21574. Epub 2016 Jun 24. — View Citation
Russell, M. (1994). New risk assessment tools for risk drinking during pregnancy. T-ACE, TWEAK, and others. Alcohol Health & Research World, 1, 55-61.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prenatal care | Utilization of obstetric and emergency department hospital care at the Turku University Hospital (medical record data concerning outpatient visits, hospital admissions) | From date of randomization until the date of delivery, assessed up to 42 gestational weeks | |
Other | Neonatal child outcome: Birth weight | Birth weight of the neonate in grams(g) | After birth up to 1 day | |
Other | Neonatal child outcome: Gestational age | Gestational age of the neonate in gestational weeks | After birth up to 1 day | |
Other | Neonatal child outcome: Apgar Score at 5 minutes | Apgar score of the neonate at 5 minutes age. Apgar score total range is 0-10 points (minimum and maximum scores), and higher total score indicates better neonatal outcome | 5 minutes after birth | |
Other | Neonatal child outcome: Head circumference | Head circumference in centimeters(cm) | After birth up to 1 day | |
Other | Neonatal child outcome: Length of hospital stay after birth | Duration of the neonate's hospital care in days | After birth up to 1 month | |
Other | Fetal drug exposure | Meconium sample for testing exposure to illicit drugs | After birth up to 7 days | |
Other | Postnatal depressive symptoms | Assessment of postnatal depressive symptoms with Edinburgh Postnatal Depression Scale (EPDS); theoretical range of the total scale is 0-30 points (minimum and maximum scores), and lower total score is indicating lower level of depressive symptoms and better outcome. | 3 months and 1 year after delivery | |
Other | Postnatal anxiety symptoms | Assessment of postnatal anxiety symptoms with The State Section of The State-Trait Anxiety Inventory (STAI): theoretical range of the total scale is 20-80 points (minimum and maximum scores), and lower total score is indicating lower level of postnatal anxiety and better outcome. | 3 months and 1 year after delivery | |
Other | Postnatal parental mentalization | Assessment of postnatal parental mentalization with Parental Reflective Functioning Questionnaire (PRFQ): theoretical range sum index 1-7 points, higher score indicating better outcome (higher mentalization) | 3 months and 1 year after delivery | |
Other | Experienced parenting stress and social support | Assessment of experienced stress in parenting and social support with Parenting Stress Index and Social Support (SPSQ): 15 items in section measuring experienced stress, sum index theoretical range 1-5 points (minimum and maximum scores), higher score indicating worse outcome (higher stress). | 3 months and 1 year after delivery | |
Other | Emotional connection and commitment with the baby | Assessment of mother's emotional connection and commitment with the baby with Postpartum Bonding Questionnaire (PBQ): theoretical range sum index 1-5 (minimum and maximum scores), higher score indicating worse outcome (weaker bonding) | 3 months and 1 year after delivery | |
Other | Neonatal neurobehavior status | Assessment of neonatal neurobehavior with Dubowitz Scale: 34 items scored with theoretical range 0-1 and total score theoretical range 0-34 points (minimum and maximum scores), higher score indicating better outcome. | After birth up to 7 days | |
Primary | Prenatal depressive symptoms 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. | Post-intervention at 35 gestational weeks | |
Secondary | Prenatal parental mentalization post-intervention at 35 gestational weeks | Assessment of prenatal parental mentalization with Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ): theoretical range of the sum index is 1-7 points (minimum and maximum scores), and higher total score is indicating higher level of parental mentalization and better outcome. | Post-intervention at 35 gestational weeks | |
Secondary | Maternal-fetal attachment post-intervention at 35 gestational weeks | Assessment of maternal-fetal attachment with Maternal-fetal Attachment Scale (MFAS): theoretical range of total scale is 24-120 points (minimum and maximum scores), and higher total score is indicating stronger maternal-fetal attachment and better outcome. | Post-intervention at 35 gestational weeks | |
Secondary | Prenatal maternal substance abuse (health behaviour) | Prenatal clinical assessments of prenatal substance abuse documented in the hospital medical records (intoxications, urine screening results, marks indicating intravenous substance abuse): The more findings, the worse the outcome. | From date of randomization until the date of delivery, assessed up to 42 gestational weeks | |
Secondary | Prenatal anxiety symptoms post-intervention at 35 gestational weeks | Assessment of prenatal anxiety symptoms with The State Section of The State-Trait Anxiety Inventory (STAI): theoretical range of total scale is 20-80points (minimum and maximum scores), and lower total score is indicating lower level of prenatal anxiety and better outcome. | Post-intervention at 35 gestational weeks |
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