What is the PROTECT-MC Study?
The goal of the PRegnancy OuTcomes: Exploring Causes & Treatment for Mother and Child (PROTECT-MC) study is to learn more about why some pregnant individuals develop pregnancy complications. The research team will investigate how prior history and experiences, environment, stress and support, activity level, and other factors might impact whether or not pregnancy complications arise.
Who is being asked to participate?
We are primarily including pregnant patients at high risk for preterm birth, preeclampsia, or other pregnancy complications. A smaller number of pregnant patients who are at low risk for pregnancy complications will also be included. Patients who are at least 8 weeks pregnant but less than 22 weeks pregnant are eligible to participate.
What will research participants have to do?
Once a participant has signed the consent and HIPAA privacy forms, they will:
- complete surveys
- have a blood draw
- have a sample of urine collected
- be provided a home water collection kit
- be provided a wristband to monitor environmental exposures
- have a body composition assessment (up to 3 times during pregnancy and once in the postpartum period) using a simple scale type device
Surveys and blood collection will be repeated several weeks after enrollment.
At delivery: provide a sample of blood, and provide a sample of cord blood and placenta after delivery (this tissue is typically discarded)
After delivery before baby is discharged: allow us to collect an extra blood spot card from your baby at the time of the state mandated newborn screening. The baby will not be stuck additional times just for this study, even if we are unable to collect blood spot research cards when the newborn screening collection is completed.
After delivery and hospital discharge, answer a brief, 5-minute survey several months after delivery
What about activity tracking / the 'FitBit' part of the study?
Patients who enroll early in pregnancy (before 14 weeks) will be provided the opportunity to wear a wrist-based activity monitor to track physical activity, sleep, and heart rate.
Are there any extra clinic study visits?
No, there are no extra visits to clinic or the hospital for the study only.
Will there be special treatments or different medications?
There are no special treatments or medications for patients in the study.
Are there any risks?
Study-related risks are low. There is a small risk that psychological distress may result from the completion of the surveys. Additionally, there is the risk loss of confidentiality, but every effort is made to protect against this. There is also a small risk of bruising with blood draw, or skin irritation from wristband or activity monitor.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
If you complete Visit 1 (samples + surveys), you will receive a $25 gift card or equivalent gift of baby care items.
If you complete Visit 2 (samples + surveys), you will receive a second $25 gift card or equivalent gift of baby care items.
be entered into a drawing based on chance, in which each participant has equal odds of receiving a $50 gift card. There will be one drawing for every 40 women who complete the initial survey, so each participant has a 1:40 chance of receiving a $50 gift card.
The goal of the PRegnancy OuTcomes: Exploring Causes & Treatment for Mother and Child (PROTECT-MC) study is to learn more about why some pregnant individuals develop pregnancy complications. The research team will investigate how prior history and experiences, environment, stress and support, activity level, and other factors might impact whether or not pregnancy complications arise.
Who is being asked to participate?
We are primarily including pregnant patients at high risk for preterm birth, preeclampsia, or other pregnancy complications. A smaller number of pregnant patients who are at low risk for pregnancy complications will also be included. Patients who are at least 8 weeks pregnant but less than 22 weeks pregnant are eligible to participate.
What will research participants have to do?
Once a participant has signed the consent and HIPAA privacy forms, they will:
- complete surveys
- have a blood draw
- have a sample of urine collected
- be provided a home water collection kit
- be provided a wristband to monitor environmental exposures
- have a body composition assessment (up to 3 times during pregnancy and once in the postpartum period) using a simple scale type device
Surveys and blood collection will be repeated several weeks after enrollment.
At delivery: provide a sample of blood, and provide a sample of cord blood and placenta after delivery (this tissue is typically discarded)
After delivery before baby is discharged: allow us to collect an extra blood spot card from your baby at the time of the state mandated newborn screening. The baby will not be stuck additional times just for this study, even if we are unable to collect blood spot research cards when the newborn screening collection is completed.
After delivery and hospital discharge, answer a brief, 5-minute survey several months after delivery
What about activity tracking / the 'FitBit' part of the study?
Patients who enroll early in pregnancy (before 14 weeks) will be provided the opportunity to wear a wrist-based activity monitor to track physical activity, sleep, and heart rate.
Are there any extra clinic study visits?
No, there are no extra visits to clinic or the hospital for the study only.
Will there be special treatments or different medications?
There are no special treatments or medications for patients in the study.
Are there any risks?
Study-related risks are low. There is a small risk that psychological distress may result from the completion of the surveys. Additionally, there is the risk loss of confidentiality, but every effort is made to protect against this. There is also a small risk of bruising with blood draw, or skin irritation from wristband or activity monitor.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
If you complete Visit 1 (samples + surveys), you will receive a $25 gift card or equivalent gift of baby care items.
If you complete Visit 2 (samples + surveys), you will receive a second $25 gift card or equivalent gift of baby care items.
be entered into a drawing based on chance, in which each participant has equal odds of receiving a $50 gift card. There will be one drawing for every 40 women who complete the initial survey, so each participant has a 1:40 chance of receiving a $50 gift card.
