Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth
This study is testing a personalized support program called PTBCARE+ to see if it can help lower stress and reduce the risk of early delivery (preterm birth) in pregnant individuals. The program includes care coordination with a research team, optional electronic massage sessions, and small gift packets with encouraging items given at different points in your pregnancy. Researchers want to know if this program lowers your stress levels, improves biological signs of stress, and increases the chance of delivering a healthy baby at or near full term. You may be able to join if you are a woman aged 18 or older with a single, viable pregnancy between 8 and 19 weeks and 6 days gestation. The study aims to enroll 1228 participants.
- Study design
- This is an interventional study, meaning participants will receive specific interventions. It plans to enroll 1228 participants.
- What's involved
- You would have regular check-ins with a care coordinator, and potentially receive electronic massage sessions and small gift packets at routine prenatal appointments. Your stress and resilience scores, and blood-based stress markers, will be measured at the beginning and mid-pregnancy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your stress and resilience scores, and blood-based stress markers, will be measured for up to 22 weeks from enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06915428
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Not Yet Recruiting
NAAges 18+InterventionalPreventionUniversity of North Carolina, Chapel HillInvestigator-initiated
~1,228 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Care coordinationElectronic massagesupport gift #1Support gift #2Support gift #3Support gift #4
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Self-reported Perceived Stress Scores
Measured over Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
+3 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Tracy Manuck, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
9 weeks 0 days to 13 weeks 6 days / crown rump length / ± 7 days
14 weeks 0 days to 15 weeks 6 days / standard fetal biometry / ± 7 days
16 weeks 0 days to 19 weeks 6 days / standard fetal biometry / ± 10 days
Gestational dating / fetal viability must be confirmed by ultrasound prior to enrollment / randomization.
Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.
Viability must be confirmed / re-confirmed within 7 days of randomization.
Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.
miPTB criteria #1: Maternal Medical History - any one of the following:
Diabetes diagnosed \<20 weeks gestation.
Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:
Antiphospholipid Antibody Syndrome
miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.
miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional / classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'
Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education
sPTB criteria #1: Prior pregnancy history
EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 /7and 276 /7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).
Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \<25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.
Asymptomatic cervical shortening \<25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications
Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider
Exclusion
Use of tobacco and/or marijuana products is not an exclusion.
Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion. 4. History of radical trachelectomy 5. Planned voluntary termination of pregnancy. 6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:
Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment
Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment
Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment 7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system
Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.
Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.
Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window. 10. Polyhydramnios at or prior to enrollment.
What this trial measures
- Self-reported Perceived Stress ScoresBaseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Perceived Stress Scale participant survey * Scores range 0-40 * Higher scores = higher stress
- Self-reported resilience scoresBaseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Brief Resilience Scale validated participant survey * score range = 1-5 * higher scores = higher resilience
- Maternal blood-based stress-related gene transcript levelsBaseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Each participant's fold change in blood-based stress-related gene transcript levels during pregnancy, calculated as a ratio: (visit 2 gene expression - visit 1 gene expression) divided by visit 1 gene expression.
- Number of participants with preterm birth or fetal death at 14 weeks 0 days or greater and less than 35 weeks gestationBetween 14 weeks 0 days and 35 weeks 0 days gestation (delivery at 34 weeks 6 days gestation meets the primary outcome; delivery at 35 weeks 0 days gestation does not) , a period of up to 27 weeks from enrollment.
Number of participants who either delivered or experienced a fetal death at a gestational age between 14 weeks 0 days and 35 weeks 0 days gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis.