Study of Ultrasound To Increase Parental Bonding in Women With Substance Use Disorders

Comparison Study of Three-Dimensional vs. Two-Dimensional Ultrasound in Measures of Maternal and Paternal Bonding

1. A randomized trial of 3-dimensional vs. 2-dimensional ultrasound, comparing scores on the Maternal Antenatal Attachment Scale (MAAS), a validated instrument measuring maternal attachment as a marker of maternal bonding. The hypothesis is that 3-dimensional ultrasound is better at eliciting maternal attachment than 2-D
2. To assess changes in maternal confidence to stop using drugs and quit/reduce smoking with 3-D vs. 2-D ultrasound. Again, the hypothesis is that 3-D ultrasound will improve the woman's confidence to stop using substances.
3. To evaluate if 3-D ultrasound improves paternal attachment as measured by pre- and post- scores on the Paternal Antenatal Attachment Scale (PAAS). The hypothesis is that 3-D ultrasound will have a greater effect on PAAS scores than 2-D.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Substance Use Disorders
• Intervention / Treatment: Other: 2 dimensional vs. 3 dimensional ultrasound

Detailed Description

To evaluate whether 3-dimensional ultrasound improves measures of maternal attachment compared with 2-D. As substance-using pregnant women are at high risk for intrauterine growth restriction (IUGR), monthly ultrasounds are indicated (Bhuvaneswar, 2008 and Mattioli, 2010). The women will receive a short questionnaire immediately before and 2 weeks after the examination at 22-32 weeks. We will randomize the women to receive either 2-D or 3-D ultrasound with a cross-over at the next ultrasound (mainly to ensure compliance with the study, as women perceive the 3-D ultrasound to be more desirable). The majority of the survey will be the Maternal Antenatal Attachment Scale (MAAS)(Condon 1993) evaluating feelings towards the fetus, pregnancy, and relationship. In addition, three questions will be added to the questionnaire, as addressed in aim 2, which specifically address confidence in the women's ability to stop using drugs and quit or decrease smoking. The main outcome measure will be comparing the pre/post-ultrasound change in the MAAS in the 3-D vs. 2-D ultrasound groups.

Secondary outcomes such as compliance with prenatal care (missed or rescheduled visits), and substance use (including smoking) are routinely collected on our women at each visit. Additionally, historical controls can be gathered from Path clinic data (previously considered exempt by University of Hawaii Committee on Human Studies on 2/24/10).

Ultrasound exams will be provided by the PI or trained ultrasonographer, using a Phillips HD11 WHC 3 and 4 dimensional ultrasound will be used. The PI is a board certified Obstetrician and Gynecologist and has had special training in the use of 3 and 4 dimensional ultrasound. This exam will be a standardized additional 5-10 minutes added onto the end of the routine scan for growth, to obtain a suitable 2-D or 3-D picture of the face and/or hand. These additional views are routinely done in the community. A 5-minute consultation will be done by the PI after each scan, with an opportunity to ask questions. If a previously undiagnosed fetal anomaly is suspected based on this scan (which is extremely unlikely given that they patient has been previously screened by perinatologists), referral for further perinatology consultation will be made. In the extremely unlikely case this happens, the ultrasounds will be covered by the patient's insurance.

The patients will be followed through their pregnancies to measure compliance with prenatal care. Data collection for the purposes of this study will end with the birth of the child.

If the father of the baby is involved, he would be asked to participate. If he consents to participate, he would complete the paternal equivalent to the MAAS (the PAAS) prior to the ultrasound and two weeks after the study.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96816
      • Recruiting
      • Path Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women with a history of substance use during pregnancy obtaining prenatal care between 24-32 weeks of pregnancy

Exclusion Criteria:

• Women less than 18, incarcerated women, women with fetal anomalies previously diagnosed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3 Dimensional ultrasound; an additional 5-10 minutes of ultrasound using three dimensional technique	Other: 2 dimensional vs. 3 dimensional ultrasound; At the end of a regularly scheduled ultrasound measuring fetal growth an additional 5-10 minute ultrasound will be performed, either in 2-dimensional or 3-dimensional mode
Active Comparator: 2 dimensional; an additional 5-10 minutes of ultrasound using standard two-dimensional technique	Other: 2 dimensional vs. 3 dimensional ultrasound; At the end of a regularly scheduled ultrasound measuring fetal growth an additional 5-10 minute ultrasound will be performed, either in 2-dimensional or 3-dimensional mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal attachment scores	Comparing the scores pre-and post ultrasound on the MAAS (maternal antenatal attachment scale) survey.	Immediately following scoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy scales, self perceived efficacy in quitting substances during pregnancy	a self-scored scale pre- and post-ultrasound	immediately
Birth Outcomes	Comparing birth outcomes including birth weight, gestational age, substance use, NICU stays between the two groups	At delivery, up to 5 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with prenatal care	comparing number of prenatal visits between the two groups	Upon birth of child. Up to five months after enrollment

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Tricia E Wright, MD MS, University of Hawaii

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: pregnancy; maternal attachment; substance use disorders; paternal attachment; three dimensional ultrasound
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: USParentalbonding; 5U54RR014607 (U.S. NIH Grant/Contract)