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临床试验/NCT02158429
NCT02158429Unknown不适用

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

University of Hawaii2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Maternal attachment scores

研究概览

简要总结

  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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Maternal attachment scores

时间窗: Immediately following scoring

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

次要结局

  • Birth Outcomes(At delivery, up to 5 months after enrollment)
  • Self-efficacy scales, self perceived efficacy in quitting substances during pregnancy(immediately)

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tricia E. Wright, M.D.

Assistant Professor

University of Hawaii

研究点 (2)

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