Participants have study visits starting during pregnancy extending through the infant’s second birthday. Pregnant participants may enroll in either their first or second trimester.
Each visit includes surveys, questionnaires, and the collection of different types of biological specimens (described below).
Pregnancy and Postpartum Visits:
In-person visits can occur during regular prenatal and postpartum care. The delivery visit occurs during the participant’s hospital admission.
- First trimester (if enrolled)
- Second trimester
- Third trimester
- Delivery
- Postpartum (4-8 weeks after delivery)
Infant Visits:
The birth visit occurs during the hospital admission for delivery. All other visits involve a telephone call with a study team member and a kit to collect biological samples, which are sent back to the study team via a courier. After your baby is born, he/she will be randomly assigned (like drawing straws) to 1 of 3 groups that will determine when he/she has a second study visit. These time point possibilities include 2 months of age, 4 months of age, or 6 months of age. A parent cannot choose which group their baby will be assigned to. All infants will then have study visits at 12 months of age and 24 months of age.
- Birth
- 2-, 4-, or 6-months
- 12 months
- 24 months
Compensation for Study Participation:
Participants are compensated for each study visit. You will receive $50 for your first study visit during pregnancy, and $25 for each of the remaining visits.
Study Activities and Sample Collections
Health Record Review: The study team will request permission to review your health record data and will ask questions about your general health, any medications you take, and details about prior pregnancies. Additionally, they will look at data contained in your Duke health record and your baby’s health record. The study team will review both your and your baby’s health record during the time that you are in the study and until your baby is 5 years of age or you are no longer receiving care within Duke University Health System.
Surveys: You will be asked to complete online surveys about topics including your environmental exposures, the types of jobs you have had or currently have, your diet, and places you have lived previously. Surveys are completed as part of each study visit and usually take 5-10 minutes.
Environmental Sampling Wristbands: You will be asked to wear a silicone wristband (similar to the yellow “Live Strong” bracelets) for ~5 days during each trimester that you are enrolled in the study. These wristbands can be used to determine how much you are exposed to common chemicals. Learn more about the environmental wristbands with the infographic below.
Maternal Vaginal Swabs: Vaginal swabs will be collected in a sterile manner and do not pose any risk of harm to you or your baby. To collect the samples, a sterile swab (similar to a Q-tip or cotton tipped swab) will be inserted into the vagina to collect the fluid within the vagina. These samples will either be self-collected by you or by your pregnancy provider during a routine clinical exam. If your samples will be self-collected, a study team member will provide you with specific instructions on how to self-collect the samples, along with supplies. You then be able to collect the samples in the privacy of an exam room. Self-collection of vaginal swabs is very quick and typically takes less than one minute. If there is any reason that you are not allowed to have a self-collected vaginal swab because of a pregnancy-related complication, you will not be included in this portion of the study. Vaginal swabs are collected at each visit during your pregnancy and at your post-partum visit. These swabs can be used to study the microbes that reside within the vagina, known as the microbiome.
Maternal Rectal Swabs: Rectal swabs will be collected in a sterile manner and do not pose any risk of harm to you or your baby. To collect the samples, a sterile swab (similar to a Q-tip or cotton tipped swab) will be inserted a short distance into the rectum. These samples will either be self-collected by you or by your pregnancy provider during a routine clinical exam. If your samples will be self-collected, a study team member will provide you with specific instructions on how to self-collect the samples, along with supplies. You will then be able to collect the samples in the privacy of an exam room. Self-collecting rectal swabs is very quick and typically takes less than one minute. Rectal swabs are collected at each visit during your pregnancy and at your post-partum visit. These swabs can be used to study the microbes that reside within your gut, known as the microbiome.
Maternal Urine Samples: Urine samples will be collected in a sterile manner, and do not pose any risk of harm to you or your baby. Urine samples are collected using the “clean catch method”, exactly the same way you usually collect samples for your prenatal visits. These samples can be used to study kidney and metabolic function, environmental exposures, and the urinary tract microbiome.
Maternal Blood Samples: Approximately 2.5 tablespoons (30 mL) of blood will be collected from you at each of your pregnancy and post-partum study visits. If you are getting a blood draw for another reason, the study team can try to collect samples for the study at the same time.
Maternal Nasal Swabs: Nasal swabs will be collected in a sterile manner and do not pose any risk of harm to you. A member of the study team will collect a few swabs from the inside of your nose. This swab is soft, similar to a Q-tip, and causes minimal discomfort. You will only have your nose swabbed during the third trimester visit, at delivery, and at your postpartum visit. These samples can be used to study the microbes that reside in your nose, known as the microbiome.
Maternal Oral Swabs: Oral swabs will be collected in a sterile manner using a soft swab, similar to a Q-tip, and do not pose any risk of harm to you. You will be asked to take the oral swab and rub your tongue for about 30 seconds with the swab at each pregnancy and post-partum study visit. These swabs can be used for a variety of research purposes, including to study immune responses, DNA, and the saliva microbiome.
Umbilical Cord Blood: After the delivery of your baby, approximately 1 tablespoon of blood will be collected from the umbilical cord. This poses no additional risk to your baby as it is collected after the cord is no longer attached. The cord blood taken for this study will not interfere with the amount collected for cord blood donation if you have opted to donate your baby’s cord blood. The cord blood can be used to study early life immune responses and the transfer of nutrients, antibodies, and other materials from the pregnant person to the infant.
Placenta: After the delivery of your baby, the placenta (afterbirth) is either discarded or sent for pathology examination. Participation in this research study would include collection of small samples of the placenta. This will not interfere with the examination of the placenta if your doctor feels pathology examination is necessary. Collection of these samples does not pose any additional risk to you or your baby. These samples can be used to study how the pregnant person and infant interact via the placenta.
Maternal Hair: At your postpartum visit, a member of the study team will collect a a small section of hair (about the width of a pencil eraser) from a discreet location at the back of your head close to your scalp. If there is not enough hair on the back of your head, the sample may be collected from another location on your scalp (with your permission). The hair can be used to study hormones such as cortisol and different environmental exposures.
Infant Oral Swab: Oral swabs will be collected in a sterile manner and do not pose any risk of harm to your baby. This swab is soft, similar to a Q-tip, and causes minimal discomfort to your baby – it is simply rubbed around the inside of the baby’s mouth. The collection supplies will be provided to you by the study team and a courier will be sent to pick up the sample when it is ready. Swabs are collected at each infant study visit. These swabs can be used for a variety of research purposes, including to study immune responses, DNA, and the saliva microbiome.
Infant Stool: Infant stool is collected by scooping a portion of stool from a recent dirty diaper into a sterile container. The collection supplies will be provided to you by the study team and a courier will be sent to pick up the sample when it is ready. Swabs are collected at each infant study visit. These samples can be used to study the microbes that reside within the gut, known as the microbiome.
Infant Nasal Swab: Nasal swabs will be collected in a sterile manner and do not pose any risk of harm to your baby. You will be supplied with instructions, sterile soft swabs, and a collection container to collect a sample from the middle of your baby’s nose. These samples can be used to study the microbes that reside in your nose, known as the microbiome.
Infant Blood Sample: Approximately 0.5-1 mL (less than 1/2 teaspoon) of blood will be collected from the heel of your baby’s foot, from an arm vein during a well-baby visit, or using a small, microneedle device that takes a very small amount of blood from a spot on your baby’s lower back. These samples can be used to study immune system function and for many other research questions.
Infant Hair Sample: After delivery, a member of the study team will collect a small section of hair (about the width of a pencil eraser) from a discreet location at the back of your baby’s head close to the scalp. If there is not enough hair on the back of your head, the sample may be collected from another location on the scalp (with your permission). The hair can be used to study hormones such as cortisol and different environmental exposures.
Frequently Asked Questions
Are there any extra visits?
There are no study visits other than the ones described above.
Are the vaginal and rectal swabs done by the research team?
No, we will provide you with the swab and you will go to the restroom to swab yourself. We will give you instructions about how to collect the swabs.
Will you collect more blood?
The study team will try to use blood that is collected as part of your regular clinical care. If your provider does not order bloodwork during your clinic visits, we will ask you if we can collect blood for the study.
How long does a visit take?
Study visits typically take around 10-15 minutes.
How will you collect samples from my baby?
A study team member will conduct a study visit with your baby shortly after delivery and will collect nasal and oral swabs, a stool sample, and cord blood (collected at delivery). For the infant visits after birth, a study team member will call you to ask about how your baby is eating and sleeping and we will talk through how to collect samples. A kit with collection supplies and instructions will be mailed to your house so that you can collect the samples from your baby including a nasal swab, oral swab, and stool sample. You will be able to call us if you have any questions. Once the samples are collected, you will call the study team, and we will send a courier to bring the samples back to the clinic.
Do the wristbands have medication on them?
No, the wristbands do not have any medication on them. They are carefully cleaned before they are given to you and wrapped in foil. You will wear the wristband for 5 days, and then rewrap it in foil before bringing it back to the study team at your next visit.
