NCT02476656

Brief Summary

Objective of study is to explore expression of stress-related genes and inflammation in placentas and umbilical cord blood for women participating in group prenatal care compared with women receiving individual prenatal care.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 2, 2018

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

May 19, 2015

Last Update Submit

August 1, 2018

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Inflammatory markers (CRP, IL-6) of cord blood

    Circulating concentrations of C-reactive protein and interleukin-6 will be quantified in serum harvested from umblical blood

    drawn from the umbilical cord within 15 minutes of delivery

Secondary Outcomes (1)

  • Genome wide expression profiling of cord blood

    drawn from the umbilical cord within 15 minutes of delivery

Study Arms (2)

GPNC

CenteringPregnancy group prenatal care

IPNC

Individual prenatal care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

preganant women who present for delivery at term at Greenville Health System with the Obstetrics Teaching Service

You may qualify if:

  • Age \>= 18 years
  • Singleton pregnancy

You may not qualify if:

  • Presence of known fetal congenital anomalies (lethal anomaly or anomalies that may lead to early delivery or increased risk of neonatal death).
  • Presence of known chromosomal abnormalities
  • Progesterone treatment during the current pregnancy after 14 weeks
  • Chronic corticosteroid (i.e. Prednisone or other steroids) treatment during the current pregnancy (not including inhalers or topical)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Amy Picklesimer, MD, MSPH

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

June 19, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

December 1, 2017

Last Updated

August 2, 2018

Record last verified: 2016-10