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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54RR014607 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Dimensional ultrasound | Active Comparator | an additional 5-10 minutes of ultrasound using three dimensional technique |
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| 2 dimensional | Active Comparator | an additional 5-10 minutes of ultrasound using standard two-dimensional technique |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 dimensional vs. 3 dimensional ultrasound | 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 |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tricia E Wright, MD MS | Contact | 808-791-9390 | tewright@hawaii.edu | |
| Jacqueline Tellei, BA | Contact | 808-791-9390 | jtellei@waikikihealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Tricia E Wright, MD MS | University of Hawaii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Path Clinic | Recruiting | Honolulu | Hawaii | 96816 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| At delivery, up to 5 months after enrollment |