National Standard for Normal Fetal Growth Study
Guest: Dr. Roger Newman – Obstetrics-Gynecology, MUSC
Host: Dr. Linda Austin – College of Medicine / Dean’s Office, MUSC
Dr. Linda Austin: Dr. Roger Newman is Professor of OB/GYN here at MUSC. Dr. Newman, you are conducting a very interesting research study looking at fetal growth curves. Tell us why this is an important issue.
Dr. Roger Newman: We’re very excited about participating in this trial. It’s sponsored by the National Institutes of Health. We are one of four centers nationwide that are participating: MUSC, Columbia University, Northwestern University, and University of California at Irvine.
Ultrasound is now a huge aspect of obstetrical care. We use it as the tool to evaluate fetal well-being, and we certainly use it as the tool to evaluate growth. The old fundal height measurement almost isn’t done anymore, appropriately so.
Unfortunately, the norms for fetal growth were established, really, 30 years ago, in the 70s and 80s, using technology that’s much inferior to what we have today. And it also used a research approach where, basically, all comers were involved. So, if you’re a six foot, two African-American woman or a five foot, two Hispanic women, your baby’s growth is being evaluated on the same growth curves. That’s not the appropriate way to do it. There are differences in fetal growth that are specific to individuals. There’s a lot of data to suggest there are ethnic differences, differences with parity. There are certainly differences that we’d expect based on the size, the height, and the weight of a woman. A variety of different factors influence that growth.
So, the purpose of the national fetal growth study is to redefine what represents normal fetal growth in uncomplicated pregnancies.
Dr. Linda Austin: Dr. Newman, tell us about the study here at MUSC. You are, I’m sure, looking for women to participate in the study. How many women, and of any particular ethnicity, or particular sort of woman?
Dr. Roger Newman: We’re trying to recruit about 600 women. We’re looking for equal distributions of African-American, Hispanic, Caucasian, and Asian women. Certain centers have some recruitment goals that are different. UC Irvine has a much higher percentage of Asian patients that they’re recruiting than we are because of our population differences. But, basically, we’re looking for any woman who is beginning their care early.
The inclusion criteria require that the woman be in the first trimester of pregnancy, it’s a low-risk pregnancy, and that the woman knows her gestational age. If not specifically the first day of her last menstrual period, at least the week that her last menstrual period occurred. We will then do a first early ultrasound to get a fetal crown-rump length measurement. To enroll in the study, we have to make sure that the crown-rump length agrees with the first day of the menstrual period that the woman remembers.
So, even though we’re looking at all different ethnicities, we’re interested in any patient that would like to participate, really, in this historic study, that is in their first trimester of pregnancy and has a low-risk pregnancy.
Dr. Linda Austin: And I would imagine, from the point of view of the woman, that she would have the fun not only of participating in a historic study; her baby is one of the babies used to set the standards, but also that she’ll have the benefit of having that ultrasound and having her baby looked at in a very meticulous way, while still in utero.
Dr. Roger Newman: We hope so. Now, I’ll be honest with you. This study is time- consuming. Over the course of the study, each participant will have six ultrasounds done at different times during their pregnancy. Each ultrasound is very detailed. So, a woman’s participation in this study will be time-consuming, and we appreciate that. We try to make it worthwhile. Obviously, there is no cost for any of these ultrasounds. There is no cost associated with any participation in the study. We have free parking, at Cannon Place, where we do the ultrasounds.
We provide each woman with a DVD, inclusive of their ultrasound pictures. We provide incentives to help defray cost. At four of their ultrasounds, they receive a $20 gift certificate, and then they receive a final gift certificate after they deliver. At two of the ultrasounds, we provide each woman with a t-shirt that has the logo of the National Fetal Growth Study, and the slogan on it says: My baby is one of the 3,000 most important babies in the U.S. And if this were on TV, you could see it.
Dr. Linda Austin: That’s a great t-shirt.
Dr. Roger Newman: And, at birth, we have a pink one and a blue one, depending in the sex of the baby. But we have a onesie that says: I am the standard by which all other babies are judged.
Dr. Linda Austin: That’s wonderful.
Dr. Roger Newman: And that’s really the truth. In 20 years; hopefully not that long, when you’re pregnant and go to your doctor’s office, one of the first things they will do, and this is very literal, is plug into the computer your age, your ethnicity, your height, your weight, how many prior children you’ve had, and probably a couple of other factors. And that computer program is going to generate a growth curve specific for your baby. In Europe, they refer to this as a customized growth curve, and that may be a little too fancy.
But, basically, the growth curves for any individual baby should be based on the expected genetic potential; influenced by environment, I’m sure, or what’s normal for this baby. And then, as you’re evaluated through the course of that pregnancy, if you’re baby is appropriate, it’s appropriate. But if it’s too small or too large, it’s going to be based on what your baby’s expectations were, as opposed to three million women who delivered in Colorado during the 1970s.
Dr. Linda Austin: Now, you mentioned this is time-consuming. How time-consuming is this?
Dr. Roger Newman: As I said, there are six ultrasound visits. We anticipate that between the ultrasound scan and a relatively quick questionnaire; what’s happened to you since we last saw you, each visit is probably going to take two to two and a half hours. In addition to the ultrasound scan, we do some basic measurements on Mom: height, weight; different body measurements. And at four of the visits, there’s a blood sample that’s drawn. We try to time the visits to when you’re having your normal blood work during pregnancy, to minimize blood sticks.
But, there are six ultrasound visits. After you deliver, one of the study coordinators will come to see you, do a questionnaire, and we’ll also see your baby and do the same measurements on your baby: their head circumference, body length, chest circumference; all different sorts of measurements on the baby, to see how well our ultrasound evaluation describes the babies once their born.
Dr. Linda Austin: Well, Dr. Newman, this sounds like a very exciting study. How long do you anticipate the study will be continuing?
Dr. Roger Newman: About two and half years.
Dr. Linda Austin: So, it will take a good while?
Dr. Roger Newman: Yes. Two years of recruitment and then another six months to finish up the deliveries on all the patients that are recruited.
Dr. Linda Austin: Now, if someone listening to this podcast wants to participate, how might she do that?
Dr. Roger Newman: I hope that there are people who would want to participate. And, if they do, they, basically, should call into our study coordinators. We are carrying out the study at two locations right now. We’re doing it here, at MUSC, for all people who would deliver at MUSC. And then we’re also doing it at the East Cooper Women’s Center, for patients who go to that practice and would deliver there.
The study coordinator for MUSC is Carolyn Williams. Her number is: (843) 792-0349. And at East Cooper Women’s Center, the coordinator is Holly Boggan. Her number is: (843) 876-1434. And, if you can’t get a hold of either one of them, you’re welcome to call me at: (843) 792-7100. We’ll arrange for you to come in to talk to us about the study, as well as your first prenatal visits, if you need that.
Dr. Linda Austin: Dr. Newman, good luck to you.
Dr. Roger Newman: Thank you very much.
If you have any questions about the services or programs offered at the Medical University of South Carolina, or if you’d like to schedule an appointment with one of our physicians, please call MUSC Health Connection at: (843) 792-1414.