Study of Ultrasound To Increase Parental Bonding in Women With Substance Use Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/2/2016 |
| Start Date: | April 2011 |
| End Date: | September 2016 |
| Contact: | Tricia E Wright, MD MS |
| Email: | tewright@hawaii.edu |
| Phone: | 808-791-9390 |
Comparison Study of Three-Dimensional vs. Two-Dimensional Ultrasound in Measures of Maternal and Paternal Bonding
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.
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.
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.
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.
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.
We found this trial at
1
site
