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

NCT03413631 | Completed

• 1 other identifier: 13924
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders; Pregnancy, High Risk; Prenatal Care; Maternal-Fetal Relations; Parenting; Depression; Anxiety; Perinatal Outcome; Fetal Exposure During Pregnancy

Keywords

prenatal substance abuse; mentalization; prenatal depression; prenatal anxiety; maternal-fetal attachment; prenatal intervention; ultrasound; perinatal outcome; fetal exposure; parenting; parenthood; prenatal treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Prenatal parental mentalization 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 maternal substance abuse (health behaviour)

  From date of randomization until the date of delivery, assessed up to 42 gestational weeks

• Prenatal anxiety symptoms post-intervention at 35 gestational weeks

  Post-intervention at 35 gestational weeks

Other Outcomes (13)

• Prenatal care

  From date of randomization until the date of delivery, assessed up to 42 gestational weeks

• Neonatal child outcome: Birth weight

  After birth up to 1 day

• Neonatal child outcome: Gestational age

  After birth up to 1 day

Study Arms (2)

Prenatal mentalization intervention

EXPERIMENTAL

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

Prenatal obstetric treatment as usual

ACTIVE COMPARATOR

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

Interventions

Prenatal mentalization intervention BEHAVIORAL

Prenatal mentalization intervention

Prenatal obstetric treatment as usual OTHER

Prenatal mentalization intervention; Prenatal obstetric treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women (pregnancy duration \< 22 gestational weeks (gwks) at referral, and singleton pregnancy) were recruited
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• pregnancy duration \< 22 gestational weeks (gwks) at referral
• singleton pregnancy.

Sponsors & Collaborators

• Turku University Hospital: lead
• Foundation for Paediatric Research, Finland: collaborator
• Academy of Finland: collaborator
• Hospital District of Southwestern Finland: collaborator
• University of Turku: collaborator

Study Sites (1)

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

Location

Related Publications (6)

• 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. doi: 10.7863/jum.2006.25.6.721.

  PMID: 16731888 BACKGROUND

• Boukydis Z. Ultrasound consultation to reduce risk and increase resilience in pregnancy. Ann N Y Acad Sci. 2006 Dec;1094:268-71. doi: 10.1196/annals.1376.032.

  PMID: 17347359 BACKGROUND

• Kokkevi, A., & Hartgers, C. (1995). EuropASI: European adaptation of a multidimensional assessment instrument for drug and alcohol dependence. Eur Addict Res, 1, 208-210.

  BACKGROUND

• 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.

  PMID: 27341555 BACKGROUND

• Russell M. New Assessment Tools for Risk Drinking During Pregnancy: T-ACE, TWEAK, and Others. Alcohol Health Res World. 1994;18(1):55-61.

  PMID: 31798157 BACKGROUND

• Jussila H, Pajulo M, Ekholm E. A Novel 4D Ultrasound Parenting Intervention for Substance Using Pregnant Women in Finland: Participation in Obstetric Care, Fetal Drug Exposure, and Perinatal Outcomes in a Randomized Controlled Trial. Matern Child Health J. 2020 Jan;24(1):90-100. doi: 10.1007/s10995-019-02773-w.

  PMID: 31250239 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD, PhD, Docent

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 29, 2018
• Study Start: October 18, 2011
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)