Recruiting

Ultrasound

Sponsor:

University of Hawaii

Code:

NCT02158429

Conditions

Substance Use Disorders

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

2 dimensional vs. 3 dimensional ultrasound

Study Details

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.

Conditions

Substance Use Disorders

Pregnancy

Study ID

NCT02158429

Start date

Apr, 2011

Status verified date

Jun, 2015

Completion date

Sep, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: 3 Dimensional ultrasound

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

active comparator: 2 dimensional

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

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

Primary outcome measure

  • Maternal attachment scores [ Time Frame: Immediately following scoring ]

Central Contacts and Locations

Central contacts

Tricia E Wright, MD MS

808-791-9390tewright@hawaii.edu

Jacqueline Tellei, BA

808-791-9390jtellei@waikikihealth.org

Locations

Path Clinic

Recruiting

Honolulu, Hawaii, United States, 96816

More Information

Sponsor

University of Hawaii

Last update posted

Jun 10, 2015

Last verified

Jun, 2015

Keywords

  • substance use disorders
  • pregnancy
  • maternal attachment
  • paternal attachment
  • three dimensional ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2015-06-10.