Preterm BirthPIINCNCT04097548
A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation
A study testing CenteringPregnancy in people with Preterm Birth, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- CenteringPregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,133 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrollment in NICHD 1R01HD082311: Centering and Racial Disparities: A Randomized Controlled Trial on CenteringPregnancy (the "CRaDle" trial).
- Pregnant women aged between 14-45 years
- Enrolled in prenatal care by 20 6/7 weeks' gestation
Who cannot join
- 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)
Show all 17Show fewer
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System
Greenville, South Carolina, 29605
About this study
Official title: Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- CenteringPregnancy
- Keywords
- Pregnancy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenteringPregnancyBehavioural
Pregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute.
| Study group | Role | What they receive |
|---|---|---|
| CenteringPregnancy group prenatal care | Experimental | Pregnant women who were randomized to receive CenteringPregnancy group prenatal care. Receives: Behavioral: CenteringPregnancy |
| Traditional individual prenatal care | No intervention | Pregnant women who were randomized to receive traditional individual prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of placental chronic inflammatory lesions, characterized histologically
Measured: Measured at delivery
Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes
Measured: Measured at delivery
Secondary outcomes (3)
Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays
Circulating inflammatory biomarkers C-reactive protein, IL-6, IL-8, IL-10, IL-13, INF-α, and TNF-α (pg/mL) in maternal serum will be measured during the second trimester between 20 weeks 0 days and 25 weeks and 6 days gestation, and during the third trimester between 32 weeks 0 days and 43 weeks 0 days
Measured: Up to 43 weeks gestation
Differential expression of mRNA gene transcripts for 34,000 human genes
Characterization of transcription control differences by exposure in maternal blood via TELiS promoter sequence analysis. Pathways involved in fetal tolerance, inflammatory activity, and organ development will be characterized. Will be measured during the second trimester between 20 weeks 0 days and 25 weeks and 6 days gestation, and during the third trimester between 32 weeks 0 days and 43 weeks 0 days. The number of differentially expressed transcripts will be totaled. Differential expression will be determined by greater than or equal to a 1.25-fold differential expression between exposure groups.
Measured: Up to 43 weeks gestation
Differential expression of mRNA gene transcripts for 34,000 human genes
Characterization of transcription control differences by exposure in fresh placental biopsies via TELiS promoter sequence analysis. Pathways involved in fetal tolerance, inflammatory activity, and organ development will be characterized. The number of differentially expressed genes will be totaled. Differential expression will be determined by greater than or equal to a 1.25-fold differential expression between exposure groups.
Measured: Measured at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start8 Aug 2018
- Primary completion31 Oct 2020
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Health-Upstate, Northwestern University, University of California, Los Angeles
- Responsible party
- Principal investigator, Ann Borders, Endeavor Health
- Investigators
- Ann Border, MD, MSc, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097548
- Sponsor's protocol ID
- EH17-256
- Acronym
- PIINC
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 2019
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
- ClinicalTrials.gov ID
- NCT04097548
- Acronym / sponsor ID
- PIINC / EH17-256
- Conditions
- Preterm Birth
- Keywords
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,133 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Prisma Health-Upstate, Northwestern University, University of California, Los Angeles
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CenteringPregnancy group prenatal care | Experimental | Behavioral: CenteringPregnancyPregnant women who were randomized to receive CenteringPregnancy group prenatal care. |
| Traditional individual prenatal care | No intervention | –Pregnant women who were randomized to receive traditional individual prenatal care. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Enrollment in NICHD 1R01HD082311: Centering and Racial Disparities: A Randomized Controlled Trial on CenteringPregnancy (the "CRaDle" trial).
- Pregnant women aged between 14-45 years
- Enrolled in prenatal care by 20 6/7 weeks' gestation
Key exclusion criteria (17 listed)
- Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care
- Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care
- Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenteringPregnancyPregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute. | Behavioural | CenteringPregnancy group prenatal care |
Primary outcome
Prevalence of placental chronic inflammatory lesions, characterized histologically
Time frame: Measured at delivery
Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes
Time frame: Measured at delivery
3 secondary outcomes
Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays
Time frame: Up to 43 weeks gestation
Differential expression of mRNA gene transcripts for 34,000 human genes
Time frame: Up to 43 weeks gestation
Differential expression of mRNA gene transcripts for 34,000 human genes
Time frame: Measured at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Border, MD, MSc principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CenteringPregnancy in people with Preterm Birth, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of placental chronic inflammatory lesions, characterized histologically (time frame: Measured at delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.