Frequently Asked Questions!


What will study participants receive?

 

* $25 for pre-enrolling while trying to get pregnant and enrolling before 45 days (around 6 weeks) pregnant. 

 

* Up to 15 pregnancy tests at no cost to you. 

 

* Early pregnancy ultrasound at no cost to you (Nashville, Knoxville, Chattanooga participants only)

 

* $10 cash or gift for completing the phone interview (about 1 hour).

 

* Women who participate in study activities involving daily web-based diaries will receive a $5 gift card for each week of

completed diaries (Women who do the web-based diaries will not be eligible for the $25 pre-enrollment incentive)

 

 

What participants will do?

 

* Answer questions about their lifestyle and health habits in one phone interview during the first trimester of pregnancy.

 

* Get an early pregnancy ultrasound, if a participant has a miscarriage before the early pregnancy ultrasound, she will still have an ultrasound (Nashville, Knoxville, Chattanooga participants only).

 

* Sign an informed consent form giving permission for study staff to review their medical records.

 

* Women planning a pregnancy may be asked to complete daily web-based diaries about symptoms they have and medicines they take before they conceive and during early pregnancy.

 

* Complete and send two update forms.

 

How about study length?

 

* We will enroll women who are trying to get pregnant and living in the middle Tennessee area in or near Davidson County, West Tennessee in or near Shelby County, the East Tennessee area in or near Knox County, and the South East area in or near Hamilton County until the summer of 2012.

 

* We are NOT currently enrolling pregnant women.

 

* Each participant will be enrolled for up to 6 months after her pregnancy ends and until all medical records related to her pregnancy have been reviewed.

 

What do I have to do to enroll in the study? 

 

Please call us toll-free at 866-346-2684 or e-mail us at rfts@vanderbilt.edu. We will tell you more about the study, answer your questions, and complete a 15 to 30 minute interview with you to find out if you are eligible. 


(Nashville Participants only) If you are eligible and would like to participate, we will ask you some additional questions. This call will take a total of about 20 to 45 minutes, depending on the parts of the study you are asked to do. If you are trying to get pregnant and meet the eligibility criteria, you can pre-enroll in the study and we'll send you pregnancy tests for up to 12 months while you are trying to get pregnant. 

 

How can I get in touch with study staff?

 

There are several ways you can reach us:


(1) Toll-free by phone:  866-346-2684
(2) Email: rfts@vanderbilt.edu
(3) Mailing address:

 

Vanderbilt University Medical Center
Institute for Medicine and Public Health
Right from the Start (RFTS)

6th Floor, Suite 600
2525 West End Avenue
Nashville, TN  37232-8300 

 

From which cities and states are you currently enrolling participants?

 

We are enrolling women who are trying to get pregnant and living in the middle Tennessee area in or near Davidson County, West Tennessee in or near Shelby County, the East Tennessee area in or near Knox County, and the South East area in or near Hamilton County until the summer of 2012.  

 

I have not chosen a prenatal care provider yet. Can I still be in the study?

 

Yes, however we will ask you to provide information about your primary care provider or another health care provider that you have seen. As a courtesy to your provider, we will forward him/her your ultrasound results. 

 

I've had problems with past pregnancies (for example, miscarriage, preterm birth, difficulty getting pregnant); can I still be in the study?

 

Yes, as long as you meet all eligibility criteria, you will be able to participate in the study regardless of your pregnancy history.

 

How will you make sure my personal information remains confidential? 

 

We take many steps to ensure that your confidentiality is protected. RFTS keeps your information in a secure database. Paper copies of information that include your name are kept in a locked file. We will assign you a study ID number to identify you while in the study. Your name and other personal identifiers are kept separate from all information you provide. Names will only be used when necessary (for example, during personal communication). 

 

Will I have to change my lifestyle (for example, stop smoking, change what I eat, exercise more, etc.)?

 

No. Participants are not asked to change anything about their daily lives or lifestyles. During the telephone interviews, we will ask several questions about lifestyles and health behaviors, including things like tobacco and alcohol use, caffeinated beverages, and exercise over the past several months. However, you will not be asked to change these behaviors. 

 

What will the ultrasound tell me? 

 

The study ultrasound is being done to confirm your pregnancy, measure early pregnancy structures and fetal heart rate, determine how many weeks pregnant you are, get an approximate due date, and measure uterine fibroids, if present. The study ultrasound is not a diagnostic test and is not being done to rule out conditions that may be harmful to you, such as an ectopic (tubal) pregnancy or to identify abnormalities of the pregnancy, uterus or ovaries.  It is very important that you seek medical care if you have concerning symptoms (Nashville, Knoxville, Chattanooga participants only).

 

 

How long will the ultrasound appointment take?

 

In general, the ultrasound appointment should not take longer than one hour. In most cases, participants will need to show up 30 minutes before their scheduled ultrasound appointment time to read and sign the consent forms, which must be signed before the ultrasound is done. When you enroll in the study, a RFTS staff member will discuss possible times with you for both the consent signing and the study ultrasound. RFTS staff will make all necessary appointments for you (Nashville, Knoxville, Chattanooga participants only).

 

Can my husband/partner/relative come with me to the ultrasound appointment?

 

  Yes. You can bring a partner or other friend/relative to your appointment. He/she can be in the same room with you when you have the ultrasound done and will be able to see the images on the ultrasound screen(Nashville participants only).


 

Is this the type of ultrasound normally done in early pregnancy?

 

Yes. This type of ultrasound is routinely done in the first trimester of pregnancy. It allows the sonographer to get the clearest and most accurate pictures early in your pregnancy (Nashville participants only).

 

Where will the study ultrasound be done?

 

In Middle Tennessee, study ultrasounds are done in Nashville at the Center for Women's Imaging near the Vanderbilt University campus. Please call RFTS toll-free at 866-346-2684 for more details (Nashville participants only).

 

 

Who will do the study ultrasound? 

 

All study ultrasounds will be done by staff with a great deal of experience in early pregnancy ultrasound. You may be seen by a sonographer, physician, or nurse-midwife who has been trained in obstetric ultrasound (Nashville participants only).

 

 

Will my prenatal care provider get a copy of my ultrasound results?

 

Yes. We will forward a copy of your ultrasound results to your provider.  If follow-up care is required, we will notify your provider immediately and ask you to get in touch with them to schedule an appointment (Nashville participants only).

 

Will I get a photograph at my ultrasound appointment?

 

Yes. Depending on the technology available at the ultrasound location, you will either get a digital still image on CD-ROM or a paper photo.


 

Can we get a videotape of the ultrasound?

 

Unfortunately, this will not be possible at any of the ultrasound locations.

 

 

Who will review completed study ultrasounds?

 

In addition to the sonographer completing your ultrasound and your prenatal care provider, the study physician and study staff who enter the information from your ultrasound into a secure database will review study ultrasounds. All ultrasound results will remain confidential.

 

Why am I receiving calls from 615-491-3619 or 615-887-5954?

 

While the study's main line is 1-866-346-2684, staff do not all work in the Nashville office daily and may use one of these study phones to contact you.