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

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

Interventions

BEHAVIORAL

Prenatal mentalization intervention

OTHER

Prenatal obstetric treatment as usual

Sponsors & Collaborators

• Foundation for Paediatric Research, Finland

  collaborator OTHER

• Academy of Finland

  collaborator OTHER

• Hospital District of Southwestern Finland

  collaborator OTHER

• University of Turku

  collaborator OTHER

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• 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

• 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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-18

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Finland

Study Locations