Clinical trial NCT04097548: A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation
Official title: Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Pregnancy
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Prisma Health-Upstate
name: Northwestern University
name: University of California, Los Angeles
First posted: 2019-09-20
Enrollment: 1133
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the PIINC study is to identify differences in placental inflammatory lesions between women participating in group prenatal care versus standard prenatal care, and additionally, examine whether the frequency of placental inflammatory lesions differ by race and income. The investigators hypothesize that women participating in group prenatal care will have lower pro-inflammatory profiles compared to women in routine prenatal care.

Detailed description: This is a supplementary investigation of placental inflammatory lesions among participants enrolled in a randomized controlled trial comparing biomedical, behavioral and psychosocial outcomes among pregnant women who participate in CenteringPregnancy group prenatal care, to women in the traditional individual prenatal care and to investigate whether improving women's stress, activation and engagement will explain the potential benefits of CenteringPregnancy on outcomes and health disparities. The study will be conducted in a large prenatal care center in South Carolina. Eligible White and Black women will be recruited before 20 weeks of gestational age with low risk pregnancy.

Eligibility criteria: Inclusion Criteria:

1. Enrollment in NICHD 1R01HD082311: Centering and Racial Disparities: A Randomized Controlled Trial on CenteringPregnancy (the "CRaDle" trial).
2. Pregnant women aged between 14-45 years
3. Enrolled in prenatal care by 20 6/7 weeks' gestation

Exclusion Criteria:

1. Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care

   * Pregestational diabetes,
   * Severe chronic hypertension requiring medication,
   * Morbid Obesity with BMI \>49.99
   * Renal disease with baseline proteinuria \>1g/24 hours
   * Any disease requiring chronic immunosuppression (SLE, solid organ transplant)
   * Active pulmonary tuberculosis
   * Sickle cell anemia
   * Human Immunodeficiency Virus Infection
   * Other medical conditions that would exclude women from group care at the discretion of the PI
2. Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care

   * Multiple gestation
   * Lethal fetal anomalies
   * Other pregnancy complications that would exclude women from group care at the discretion of the PI
3. Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care

   * Current incarceration
   * Severe psychiatric illness

Primary outcomes:
measure: Prevalence of placental chronic inflammatory lesions, characterized histologically
timeFrame: Measured at delivery
measure: Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes
timeFrame: Measured at delivery
Secondary outcomes:
measure: Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays
timeFrame: Up to 43 weeks gestation
measure: Differential expression of mRNA gene transcripts for 34,000 human genes
timeFrame: Up to 43 weeks gestation
measure: Differential expression of mRNA gene transcripts for 34,000 human genes
timeFrame: Measured at delivery
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
affiliation: Endeavor Health
name: Ann Border, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: