Placental Inflammation in Prenatal Care

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02476656

Acronym

PINC

Enrollment

Registered

2015-06-19

Start date

2015-06-30

Completion date

2017-12-31

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Inflammatory markers (CRP, IL-6) of cord blood	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

Measure	Time frame	Description
Genome wide expression profiling of cord blood	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.

Outcome results