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

Primary Purpose

Substance Use Disorders, Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 dimensional vs. 3 dimensional ultrasound
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders focused on measuring substance use disorders, pregnancy, maternal attachment, paternal attachment, three dimensional ultrasound

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Path ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

3 Dimensional ultrasound

2 dimensional

Arm Description

an additional 5-10 minutes of ultrasound using three dimensional technique

an additional 5-10 minutes of ultrasound using standard two-dimensional technique

Outcomes

Primary Outcome Measures

Maternal attachment scores
Comparing the scores pre-and post ultrasound on the MAAS (maternal antenatal attachment scale) survey.

Secondary Outcome Measures

Self-efficacy scales, self perceived efficacy in quitting substances during pregnancy
a self-scored scale pre- and post-ultrasound
Birth Outcomes
Comparing birth outcomes including birth weight, gestational age, substance use, NICU stays between the two groups

Full Information

First Posted
February 12, 2014
Last Updated
June 8, 2015
Sponsor
University of Hawaii
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT02158429
Brief Title
Study of Ultrasound To Increase Parental Bonding in Women With Substance Use Disorders
Official Title
Comparison Study of Three-Dimensional vs. Two-Dimensional Ultrasound in Measures of Maternal and Paternal Bonding
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hawaii
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Pregnancy
Keywords
substance use disorders, pregnancy, maternal attachment, paternal attachment, three dimensional ultrasound

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 Dimensional ultrasound
Arm Type
Active Comparator
Arm Description
an additional 5-10 minutes of ultrasound using three dimensional technique
Arm Title
2 dimensional
Arm Type
Active Comparator
Arm Description
an additional 5-10 minutes of ultrasound using standard two-dimensional technique
Intervention Type
Other
Intervention Name(s)
2 dimensional vs. 3 dimensional ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Maternal attachment scores
Description
Comparing the scores pre-and post ultrasound on the MAAS (maternal antenatal attachment scale) survey.
Time Frame
Immediately following scoring
Secondary Outcome Measure Information:
Title
Self-efficacy scales, self perceived efficacy in quitting substances during pregnancy
Description
a self-scored scale pre- and post-ultrasound
Time Frame
immediately
Title
Birth Outcomes
Description
Comparing birth outcomes including birth weight, gestational age, substance use, NICU stays between the two groups
Time Frame
At delivery, up to 5 months after enrollment
Other Pre-specified Outcome Measures:
Title
Compliance with prenatal care
Description
comparing number of prenatal visits between the two groups
Time Frame
Upon birth of child. Up to five months after enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tricia E Wright, MD MS
Phone
808-791-9390
Email
tewright@hawaii.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Tellei, BA
Phone
808-791-9390
Email
jtellei@waikikihealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tricia E Wright, MD MS
Organizational Affiliation
University of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
Path Clinic
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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