Clinical trial NCT02158429: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Pregnancy
Keywords: substance use disorders
pregnancy
maternal attachment
paternal attachment
three dimensional ultrasound
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2014-06-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Maternal attachment scores
timeFrame: Immediately following scoring
Secondary outcomes:
measure: Self-efficacy scales, self perceived efficacy in quitting substances during pregnancy
timeFrame: immediately
measure: Birth Outcomes
timeFrame: At delivery, up to 5 months after enrollment
Other outcomes:
measure: Compliance with prenatal care
timeFrame: Upon birth of child. Up to five months after enrollment
Locations:
city: Honolulu
country: United States
facility: Path Clinic
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Tricia E Wright, MD MS
role: PRINCIPAL_INVESTIGATOR
References: