NCT03413631

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

Completed NA Last updated 29 January 2018

What this trial tests

NA trial testing Prenatal mentalization intervention in Substance-Related Disorders in 126 participants. Completed in 31 December 2015.

Timeline

18 October 2011

Primary endpoint
31 December 2015

31 December 2015

Quick facts

Lead sponsor	Turku University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	18 October 2011
Primary completion	31 December 2015
Estimated completion	31 December 2015
Sites	1 location across Finland

Drugs / interventions tested

• Prenatal mentalization intervention
• Prenatal obstetric treatment as usual

Conditions studied

• Substance-Related Disorders — all drugs for Substance-Related Disorders →
• Pregnancy, High Risk — all drugs for Pregnancy, High Risk →
• Prenatal Care — all drugs for Prenatal Care →
• Maternal-Fetal Relations — all drugs for Maternal-Fetal Relations →

Sponsor

Turku University Hospital

Who can join

18 and older, female only, with Substance-Related Disorders or Pregnancy, High Risk. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Jussila H, Pajulo M, Ekholm E. · · 2020 · cited 5× · PMID 31250239 · DOI 10.1007/s10995-019-02773-w