Placental Inflammation in Prenatal Care

Preterm Birth Clinical Trial

— PINC  

Official title:

Placental Inflammation in Prenatal Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476656
• Other study ID #: Pro#00037264
• Status: Completed
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Greenville Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Greenville Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Genome wide expression profiling of cord blood	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.	drawn from the umbilical cord within 15 minutes of delivery