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Trial record 9 of 1519 for:    child psychiatry

A Prenatal Mentalization-focused 4D Ultrasound and a Pregnancy Diary Intervention for Substance-abusing Women

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ClinicalTrials.gov Identifier: NCT03413631
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborators:
Foundation for Paediatric Research, Finland
Academy of Finland
Hospital District of Southwestern Finland
University of Turku
Information provided by (Responsible Party):
Eeva Ekholm, Turku University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Substance-Related Disorders Pregnancy, High Risk Prenatal Care Maternal-Fetal Relations Parenting Depression Anxiety Perinatal Outcome Fetal Exposure During Pregnancy Behavioral: Prenatal mentalization intervention Other: Prenatal obstetric treatment as usual Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants were randomized into the intervention and control groups using a computer-generated block-randomization with block size of four. A separate randomisation assignment was used for women medication-assisted treatment for opioid addiction.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prenatal Mentalization-focused 4D Ultrasound and a Pregnancy Diary Intervention for Substance-abusing Women
Actual Study Start Date : October 18, 2011
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Ultrasound

Arm Intervention/treatment
Experimental: 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).
Behavioral: Prenatal mentalization intervention
Other: Prenatal obstetric treatment as usual
Active Comparator: 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



Primary Outcome Measures :
  1. Prenatal depressive symptoms post-intervention at 35 gestational weeks [ Time Frame: 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.


Secondary Outcome Measures :
  1. Prenatal parental mentalization post-intervention at 35 gestational weeks [ Time Frame: 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.

  2. Maternal-fetal attachment post-intervention at 35 gestational weeks [ Time Frame: 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.

  3. Prenatal maternal substance abuse (health behaviour) [ Time Frame: From date of randomization until the date of delivery, assessed up to 42 gestational weeks ]
    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.

  4. Prenatal anxiety symptoms post-intervention at 35 gestational weeks [ Time Frame: 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.


Other Outcome Measures:
  1. Prenatal care [ Time Frame: From date of randomization until the date of delivery, assessed up to 42 gestational weeks ]
    Utilization of obstetric and emergency department hospital care at the Turku University Hospital (medical record data concerning outpatient visits, hospital admissions)

  2. Neonatal child outcome: Birth weight [ Time Frame: After birth up to 1 day ]
    Birth weight of the neonate in grams(g)

  3. Neonatal child outcome: Gestational age [ Time Frame: After birth up to 1 day ]
    Gestational age of the neonate in gestational weeks

  4. Neonatal child outcome: Apgar Score at 5 minutes [ Time Frame: 5 minutes after birth ]
    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. Neonatal child outcome: Head circumference [ Time Frame: After birth up to 1 day ]
    Head circumference in centimeters(cm)

  6. Neonatal child outcome: Length of hospital stay after birth [ Time Frame: After birth up to 1 month ]
    Duration of the neonate's hospital care in days

  7. Fetal drug exposure [ Time Frame: After birth up to 7 days ]
    Meconium sample for testing exposure to illicit drugs

  8. Postnatal depressive symptoms [ Time Frame: 3 months and 1 year after delivery ]
    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.

  9. Postnatal anxiety symptoms [ Time Frame: 3 months and 1 year after delivery ]
    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.

  10. Postnatal parental mentalization [ Time Frame: 3 months and 1 year after delivery ]
    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)

  11. Experienced parenting stress and social support [ Time Frame: 3 months and 1 year after delivery ]
    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).

  12. Emotional connection and commitment with the baby [ Time Frame: 3 months and 1 year after delivery ]
    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)

  13. Neonatal neurobehavior status [ Time Frame: After birth up to 7 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only pregnant women (pregnancy duration < 22 gestational weeks (gwks) at referral, and singleton pregnancy) were recruited
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413631


Locations
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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, Finland
Sponsors and Collaborators
Turku University Hospital
Foundation for Paediatric Research, Finland
Academy of Finland
Hospital District of Southwestern Finland
University of Turku
Investigators
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Principal Investigator: Eeva Ekholm, MD, PhD Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, PL 52, 20521 Turku, Finland Department of Obstetrics and Gynecology, University of Turku, 20014 Turku, Finland
Principal Investigator: Marjukka Pajulo, MD, PhD Department of Child Psychiatry, Turku University Hospital, Kiinamyllynkatu 4-8, PL 52, 20521 Turku, Finland Department of Child Psychiatry and Finn Brain, University of Turku, 20014 Turku, Finland

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eeva Ekholm, Consultant, MD, PhD, Docent, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03413631     History of Changes
Other Study ID Numbers: 13924
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eeva Ekholm, Turku University Hospital:
prenatal substance abuse
mentalization
prenatal depression
prenatal anxiety
maternal-fetal attachment
prenatal intervention
ultrasound
perinatal outcome
fetal exposure
parenting
parenthood
prenatal treatment
Additional relevant MeSH terms:
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Substance-Related Disorders
Depression
Behavioral Symptoms
Mental Disorders
Chemically-Induced Disorders