An interventional study of Prenatal mentalization intervention and Prenatal obstetric treatment as usual in Substance-Related Disorders, Pregnancy, High Risk and Prenatal Care, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
Description of the intervention and the control condition:
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 prenatal sessions and option for one diary session after delivery. Detailed intervention method description including a theoretical background of the intervention is already published and available (Pajulo et al. 2016).
Mentalization-focused interactive use of 4D ultrasound imaging:
Three interactive 4D ultrasound sessions were offered for the intervention group participants at 24, 30 and 34 gestational weeks at the maternity outpatient clinic. The pregnant women participated in the sessions alone. The ultrasound sessions took around 20-30 minutes, and were performed by an experienced obstetrician and an infant mental health professional working in cooperation. The sessions were based on the intervention method called "ultrasound consultation" (Boukydis \& Stockman, 2012; Boukydis, 2006) where the idea is to observe the fetus together with the parent(s); the fetal features, position, sleep-awake rhythm, personal characteristics, activities in the uterus and responses to mother's initiatives for interaction.The aim is to evoke the mother's active interest in this particular child and hence to enhance parental mentalization and maternal-fetal attachment.
To keep the fetus more actively in the mother's mind across pregnancy, a new mentalization-focused pregnancy diary was designed for the intervention group. Three prenatal meetings (45 minutes) with the infant mental health professional were offered for reflecting the mother's experiences on using the diary. The diary contains short sections for each pregnancy week including information about pregnancy, fetal development and health promoting practices. The key elements in the diary are the mentalization-focused questions and tasks encouraging the pregnant woman to reflect on her fetus and pregnancy and becoming a parent.
The control condition:
The intervention and control group received active treatment as usual in an obstetric tertiary setting, and treatment as usual formed the control condition for the intervention. The treatment was offered by a multidisciplinary team consisting of an obstetrician, a midwife, a social worker and a psychiatric nurse . The patients were referred to addiction and psychiatric treatment when needed. The Child Protection Services were involved in prenatal phase in accordance with the Finnish legislation.
Data collection:
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 pregnant woman and her child were followed-up until the child was one year old. The data was collected from multiple sources: standardized measures, questionnaires constructed for the study and information available from hospital medical records. As a part of routine clinical practice, the pregnant women were interviewed by the psychiatric nurse and the social worker. The interviews based on the European Addiction Severity Index-questionnaire (EuropASI) (Kokkevi \& Hartgers, 1995), where the items regard maternal physical and mental health, substance abuse, employment and income, legal status and close relationships. Sociodemographic data was obtained by a ten-item questionnaire at baseline. Information regarding maternal psychiatric diagnosis and/or history was based on documented self-report or medical records. Information regarding maternal substance abuse was obtained through the medical records, and was based on maternal self-report or clinical documentation (intoxications, urine screening results, marks indicating intravenous substance abuse). Meconium sample was collected after birth for detection of illicit drugs. Data regarding utilisation of obstetric care and perinatal outcome was obtained from hospital medical records.
The standardized measures used to assess maternal depressive and anxiety symptoms, maternal-fetal attachment and parental mentalization were administered during pregnancy at two time points, i.e. before and after intervention (\< 24th and > 34th gestational weeks, respectively). Routine postnatal follow-up visits at the socio pediatric unit were conducted when the infant was at 3 months and 1 year age. Standardized measures were administered during those follow-up visits to assess maternal postnatal depressive and anxiety symptoms, parental mentalization, experienced stress from parenting and experienced social support, and emotional connection and commitment with the baby. Medical records concerning health and psychosocial situation of the mother and infant were available, based on informed consent, until the child was one year old. The assessment time points and measures were the same for both groups.
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.
2,241 studies on the registry are indexed under Substance-Related Disorders; 410 are open to participants now.
This study's enrollment of 126 is above the median of 108 across 1,843 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Turku University Hospital is the lead sponsor of 288 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
and/or sum score ≥ 3 points on TWEAK alcohol screening (Russell, 1994).
The inclusion criteria included also:
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).
Behavioral: Prenatal mentalization intervention · 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.
Other: Prenatal obstetric treatment as usual
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.
Time frame: Post-intervention at 35 gestational weeks
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.
Time frame: Post-intervention at 35 gestational weeks
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.
Time frame: Post-intervention at 35 gestational weeks
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.
Time frame: From date of randomization until the date of delivery, assessed up to 42 gestational weeks
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.
Time frame: Post-intervention at 35 gestational weeks
Prenatal care
Utilization of obstetric and emergency department hospital care at the Turku University Hospital (medical record data concerning outpatient visits, hospital admissions)
Time frame: From date of randomization until the date of delivery, assessed up to 42 gestational weeks
Neonatal child outcome: Birth weight
Birth weight of the neonate in grams(g)
Time frame: After birth up to 1 day
Neonatal child outcome: Gestational age
Gestational age of the neonate in gestational weeks
Time frame: After birth up to 1 day
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
Time frame: 5 minutes after birth
Neonatal child outcome: Head circumference
Head circumference in centimeters(cm)
Time frame: After birth up to 1 day
Neonatal child outcome: Length of hospital stay after birth
Duration of the neonate's hospital care in days
Time frame: After birth up to 1 month
Fetal drug exposure
Meconium sample for testing exposure to illicit drugs
Time frame: After birth up to 7 days
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.
Time frame: 3 months and 1 year after delivery
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.
Time frame: 3 months and 1 year after delivery
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)
Time frame: 3 months and 1 year after delivery
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).
Time frame: 3 months and 1 year after delivery
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)
Time frame: 3 months and 1 year after delivery
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.
Time frame: After birth up to 7 days
Plan to share: No
Ran from Oct 2011 to primary completion in Dec 2015, 50 months.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 50 months is above that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.