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PRegnancy OuTcomes: Exploring Causes & Treatment for Mother and Child (the PROTECT-MC study)

This purpose of this study is to investigate how your prior history and experiences, environment, stress and support, activity level, and other factors might impact if you develop pregnancy complications. We are primarily including patients who are currently pregnant and who are at high risk for preterm birth or preeclampsia and a smaller number of patients who are pregnant and are at low risk for pregnancy complications. This study is observational only. No special treatments or medications are provided if you participate in the study. There are no extra clinic or hospital visits for the study. The information and samples we collect will be used to study preterm birth, preeclampsia, and other pregnancy complications; this information will also be stored in a repository for future investigations of pregnancy-related conditions and other conditions that affect pregnant patients and their offspring.

Age & Gender

  • 18 years ~ 50 years
  • Female

Visit Availability

  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

All study visits are during regular prenatal care visits. As a part of this study, we will ask you to: * Answer survey questions on a tablet device, and provide a blood sample, urine sample, and vaginal swabs at two separate time points. Survey questions can also be completed on your own electronic device at home. * Send in a sample of water from your home, using a collection tube and mailing envelope we provide * Wear a soft silicone wristband for 5-7 days (up to two times) to collect direct information regarding environmental exposures such as what is in the dust in your home and work environment * Obtain body composition assessments up to 3 times during pregnancy and once in the postpartum period using a simple scale type device. * At delivery: provide a sample of blood when you are admitted to the hospital, and provide a sample of cord blood and placenta after delivery (this tissue is typically discarded) * Allow us to collect an extra blood spot card from your baby at the time of the state mandated newborn screening. Your 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. * Answer a brief, 5-minute survey several months after delivery * Patients who enroll early in pregnancy will be provided the opportunity to wear a wrist-based activity monitor to track physical activity, sleep, and heart rate

Incentives

up to $70 in gift cards or baby care items for study visit completion and return of environmental wristbands, and up to 6 entries into 6 different $50 giftcard drawings, where each entry has a 1:50 chance of winning. The chance of receiving a giftcard from the drawings depends on the number of study activities you complete. , FitBit activity tracker, water bottle, tote bag, report of water quality from your home and a water filter if your water sample is abnormal, detailed printout of body composition information

In-person visits:
2
Total length of participation:
9-12 months

Looking for Specific Volunteers

Able to participate:

  • Pregnant
  • Less than 22 weeks gestation at enrollment
  • High-risk for preterm birth
  • (smaller group of patients at low risk for pregnancy complications are included)

Not eligible if:

  • Are carrying a baby with a chromosomal problem or certain major abnormalities on ultrasound.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

OB/GYN Clinic
UNC Health at Weaver Crossing
1181 Weaver Dairy Rd, Chapel Hill, NC 27514, USA

Secondary Contact

Secondary Visit Location

UNC Maternal-Fetal Medicine at Vilcom Center
55 Vilcom Center Dr Ste 300, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Tracy Manuck
Obstetrics and Gynecology-Maternal Fetal Medicine

Study Type

Clinical or Medical
Observational

Study Topics

Blood Pressure
Environment
Minority Health
Pregnancy
Sleep
Women's Health
Movement

IRB Number

22-0572

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