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OpenTrials
Completed

NCT Number: NCT02476656

Placental Inflammation in Prenatal Care

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

This study aims to evaluate levels of inflammatory markers and genetic indicators of stress an inflammation in the placentas and umbilical cord blood in pregnancies that undergo group prenatal care as compared to traditional prenatal care. The investigators know that women receiving group prenatal care have fewer spontaneous preterm deliveries. What is not known is the mechanism behind this difference. By collecting umbilical cord blood samples and placentas of 40 women at the time of delivery, the investigators hope to study expression of stress-related genes and levels of inflammatory markers at the maternal-fetal interface.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years
  • Singleton pregnancy

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

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

    Time frame: drawn from the umbilical cord within 15 minutes of delivery

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

Secondary outcomes

  1. Genome wide expression profiling of cord blood

    Time frame: drawn from the umbilical cord within 15 minutes of delivery

    Mononuclear cells will be isolated from umbilical blood using density gradient centrifugation. RNA will be extracted using Qiagen RNeasy Mini Kits, and quality/quantity checks performed using an Agilent NanoDrop BioAnalyzer.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Acronym: PINC

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 19, 2015
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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