Determinants of Fetal Inflammatory Exposure at Term

This study has been completed.
Sponsor:
Collaborator:
March of Dimes
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00970151
First received: February 19, 2008
Last updated: October 9, 2009
Last verified: October 2009
  Purpose

The hypothesis of this study is that maternal and fetal biologic variation in the balance between pro-inflammatory and anti-inflammatory mediators can be measured by currently available techniques. In addition, the investigators hypothesize that a pro-inflammatory maternal phenotype increases the risk of fetal exposure to intrauterine hyperthemia and inflammatory cytokines; and that intrapartum events, especially known risk factors for fever at term such as epidural analgesia and prolonged rupture of membranes, may interact with underlying maternal factors to increase fetal exposure to inflammatory cytokines.

This experiment aims to establish the first large-scale cohort to evaluate biomarkers for maternal and fetal inflammation in term pregnancy and to elucidate the relative antepartum and intrapartum contributions to fetal inflammation.


Condition
Maternal-Fetal Relations

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Fetal Inflammatory Exposure at Term

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Fetal exposure to inflammation as assessed by cord cytokine levels [ Time Frame: During birth ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole blood, blood serum, placenta, spinal fluid (for some subjects)


Enrollment: 618
Study Start Date: June 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

It has been demonstrated that intrapartum fever >100.4 degrees Fahrenheit is associated with increased maternal and fetal levels of interleukin-6 (IL-6) at delivery. Maternal and fetal IL-6 levels are highly correlated, and placental transport of cytokines has been demonstrated. While intrapartum fever is traditionally attributed to acquired infection (chorioamnionitis), our data indicate that the maternal inflammatory balance assessed prior to the onset of labor may be a significant determinant of subsequent intrapartum fever. The increased risk of neonatal brain injury may be cytokine mediated or may, in part, be secondary to increased vulnerability to hypoxic injury in the setting of elevated fetal brain temperature.

The baseline prevalence of intrapartum fever at term is 1-5%. Factors associated with an increased risk of intrapartum fever include maternal age, nulliparity (75%), Hispanic race, induction and longer labor. However, in recent years, the most potent risk factor for intrapartum fever has clearly been epidural analgesia - which is selected for intrapartum pain relief by the majority of mothers in the US especially in the first, most painful birth. We have demonstrated that the risk of fever after epidural analgesia increases with increasing duration of epidural analgesia - therefore, the risk of fever after epidural analgesia is largely confined to nulliparous women. Multiparous women deliver shortly after the onset of active labor, resulting in a short duration of exposure to epidural analgesia, and are not at increased risk. Randomized studies demonstrate that the independent contribution of epidural analgesia to intrapartum fever risk is 3 to 7-fold. Rates of intrapartum fever >100.4 degrees Fahrenheit in nulliparas with epidural analgesia range from 14.5% to 33%. Rates at the upper end of this range are observed in large, public hospitals with primarily Hispanic populations. Conversely, lower rates are observed at private hospitals with primarily Caucasian populations.

This study will make observations based upon:

  1. 10 mL of blood drawn the day of enrollment
  2. 10 mL of blood drawn upon admission to Labor and Delivery
  3. A sample of spinal fluid if a spinal epidural is chosen by the patient
  4. Blood collected from the placenta and umbilical cord

In addition, the mother's temperature will be taken every hour during labor.

  Eligibility

Ages Eligible for Study:   14 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

600 racially and ethnically diverse nulliparas who present to the Prenatal Wellness Center at Cannon Place and Northwoods Clinic with a full term (>37 weeks) pregnancy and who deliver in the Labor and Delivery Suite at MUSC Hospital

Criteria

Inclusion Criteria:

  • Nulliparity
  • Singleton gestation
  • Full term (>37 weeks) pregnancy
  • Vertex presentation
  • Candidate for trial of labor
  • Ability to provide informed consent

Exclusion Criteria:

  • Multiple gestation
  • Autoimmune Disease
  • Treatment with anti-inflammatory agents during pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970151

Locations
United States, South Carolina
Medical Univeristy of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
March of Dimes
Investigators
Principal Investigator: Laura Goetzl, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Laura Goetzl, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00970151     History of Changes
Other Study ID Numbers: HR # 15251, 6-FY06-311
Study First Received: February 19, 2008
Last Updated: October 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Fetal Inflammation
Birth Outcome
Pregnancy

ClinicalTrials.gov processed this record on September 18, 2014