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Prenatal Care Support Study for Stress Management, Health Equity, and Preterm Birth Prevention

The purpose of this study is to find out if people who are at high risk for having a preterm birth (a baby born too early) have better pregnancy outcomes when they receive extra support through a personalized prenatal care program, called PTBCARE+, compared to those who do not get this extra support. Participants have a 2 in 3 chance (better odds than flipping a coin) of being in the PTBCARE+ group. There won't be any additional clinic or hospital visits required just for the study. The information and samples we collect will help us learn more about conditions like preterm birth and preeclampsia, and other important pregnancy outcomes. These samples and information will be stored in a repository, where they can be used in future research on pregnancy and other health conditions that affect pregnant individuals and their babies.

Age & Gender

  • 18 years ~ 55 years
  • Female

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

* Random Assignment: You will be randomly assigned (like a coin flip) to either receive extra support through the PTBCARE+ program or continue with traditional prenatal care. Neither you nor the researcher will choose your assigned group. * Surveys: You'll complete surveys either on a tablet device, paper, or your own device at two points during pregnancy and once after delivery. * Measurements: At two points during pregnancy, we'll measure your body composition (similar to using a scale) and heart rate variability (using a small clip on your ear or finger) * Samples: You'll provide an extra blood and urine sample twice during pregnancy, often collected with your regular clinical lab work. * PTBCARE+ Program Support (if assigned): (a) Online Modules: Access resources to help lower stress and improve overall well-being; (b) Support Messages: Receive text, email, or MyChart messages from the study team; (c) Additional Resources: Get access to a stress reduction toolkit, electronic massage at prenatal visits, and specialized PTBCARE+ Care Coordination. * Optional Postpartum Activities: You can choose to participate in follow-up measurements, including body composition, blood and urine sample, and heart rate variability after delivery.

Incentives

At least $50 in gift cards or baby care items ($20 after Visit 1, $20 after Visit 2, and $10 after postpartum study activities). Those randomly assigned to the PTBCARE+ program have the potential to received additional compensation., Participants randomly assigned to the PTBCARE+ program will receive additional resources including a stress reduction toolkit, support gifts, access to an electronic massage at their prenatal visits, PTBCARE+ Care Coordination, and more.

In-person visits:
up to 3 (all at the time of your regularly scheduled prenatal visits)
Phone or online visits:
It is anticipated that most people will complete 7-10 online only visits but participants can choose to complete up to 70 visits.
Total length of participation:
From enrollment in early pregnancy until up to 10 weeks after delivery

Looking for Specific Volunteers

Able to participate:

  • You are currently pregnant with a single baby.
  • You are at high-risk for delivering early due to medical problems / complications OR spontaneous preterm labor
  • You are interested in possibly receiving personalized support during pregnancy

Not eligible if:

  • You are under 18 years old or older than 55 years old.
  • You are currently using illicit drugs or substances.
  • You are pregnant with twins.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

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

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

Behavioral or Social
Interventional

Study Topics

Mental and Emotional Health
Minority Health
Pregnancy
Sleep
Wellness and Lifestyle
Women's Health

IRB Number

23-1779

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