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

NCT ID: NCT02158429

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-09-30

Brief Summary

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.

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.

Conditions

Substance Use Disorders; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

3 Dimensional ultrasound

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

Group Type: ACTIVE_COMPARATOR

2 dimensional vs. 3 dimensional ultrasound

Intervention Type: OTHER

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

2 dimensional

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

Group Type: ACTIVE_COMPARATOR

2 dimensional vs. 3 dimensional ultrasound

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Tricia E. Wright, M.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tricia E Wright, MD MS

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii

Locations

Path Clinic

Honolulu, Hawaii, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tricia E Wright, MD MS

Role: CONTACT

tewright@hawaii.edu

808-791-9390

Jacqueline Tellei, BA

Role: CONTACT

jtellei@waikikihealth.org

808-791-9390

Other Identifiers

5U54RR014607

Identifier Type: NIH

Identifier Source: secondary_id

View Link

USParentalbonding

Identifier Type: -

Identifier Source: org_study_id