Maternal-Fetal RelationsNCT00970151
Determinants of Fetal Inflammatory Exposure at Term
An observational study of Maternal-Fetal Relations, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Relations
- How many people
- 618 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 48 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Nulliparity
- Singleton gestation
- Full term (>37 weeks) pregnancy
- Vertex presentation
- Candidate for trial of labor
- Ability to provide informed consent
Who cannot join
- Multiple gestation
- Autoimmune Disease
- Treatment with anti-inflammatory agents during pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Univeristy of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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:
- 10 mL of blood drawn the day of enrollment
- 10 mL of blood drawn upon admission to Labor and Delivery
- A sample of spinal fluid if a spinal epidural is chosen by the patient
- Blood collected from the placenta and umbilical cord
In addition, the mother's temperature will be taken every hour during labor.
- Conditions
- Maternal-Fetal Relations
- Keywords
- Fetal Inflammation, Birth Outcome, Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal exposure to inflammation as assessed by cord cytokine levels
Measured: During birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJun 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal-Fetal RelationsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- March of Dimes
- Investigators
- Laura Goetzl, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970151
- Sponsor's protocol ID
- HR # 15251
- Other IDs
- 6-FY06-311
- Status last verified
- Oct 2009
- First submitted
- 19 Feb 2008
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Fetal Inflammatory Exposure at Term
- ClinicalTrials.gov ID
- NCT00970151
- Acronym / sponsor ID
- HR # 15251
- Conditions
- Maternal-Fetal Relations
- Keywords
- Fetal Inflammation, Birth Outcome, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- March of Dimes
- Study start
- Jun 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 10 mL of blood drawn the day of enrollment
- 10 mL of blood drawn upon admission to Labor and Delivery
- A sample of spinal fluid if a spinal epidural is chosen by the patient
- Blood collected from the placenta and umbilical cord
In addition, the mother's temperature will be taken every hour during labor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- Nulliparity
- Singleton gestation
- Full term (>37 weeks) pregnancy
- Vertex presentation
- Candidate for trial of labor
Key exclusion criteria (3 listed)
- Multiple gestation
- Autoimmune Disease
- Treatment with anti-inflammatory agents during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal exposure to inflammation as assessed by cord cytokine levels
Time frame: During birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Goetzl, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal-Fetal Relations, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal exposure to inflammation as assessed by cord cytokine levels (time frame: During birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2009.