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Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2008
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00340899
  Purpose

Preterm delivery, preeclampsia and intrauterine growth restriction are leading causes of perinatal morbidity and mortality. Efforts to treat these syndromes have not been effective, most likely becuase these obstetric complications are the clinical expression of adaptive mechanisms of host defense developed in response to pathologic insults. Since the ultimate pathologic basis of disease is unclear, therapy for these syndromes has been largely directed at symptoms, which appear late in the development of the disease. The main purpose of this study is to perform an early and comprehensive exploration of maternal and fetal factors that predict the subsequent develpment of these obstetrice complications, so that early medical interventions may be tested in patients at high and low risk for adverse perinatal outcome.


Condition
Maternal Fetal Factors

U.S. FDA Resources
Study Type: Observational
Official Title: Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longitudinal Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 14079
Study Start Date: December 1997
Detailed Description:

Preterm delivery, preeclampsia and intrauterine growth restriction are leading causes of perinatal morbidity and mortality. Efforts to treat these syndromes have not been effective, most likely because these obstetric complications are the clinical expression of adaptive mechanisms of host defense developed in response to pathologic insults. Since the ultimate pathologic basis of disease is unclear, therapy for these "syndromes" has been largely directed at symptoms, which appear late in the development of the disease. The main purpose of this study is to perform an early and comprehensive exploration of maternal and fetal factors that predict the subsequent development of these obstetric complications, so that early medical interventions may be tested in patients at high and low risk for adverse perinatal outcome.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Gestational age between 6 and 22 weeks for the first visit.

High risk group: presence of specific risk factors for preterm delivery, pregnancy-induced hypertension or intrauterine growth retardation.

Low risk group: normal pregnancy with no risk factors for either preterm delivery, pregnancy-induced hypertension or intrauterine growth retardation (control population, selected between 6 and 22 weeks at the prenatal care clinic). The rationale to include this group is that 50-70% of preterm deliveries occur in patients without risk factors for preterm birth.

Consent to participate in the study.

Patient should be able to attend to the Perinatal Research Center for prenatal care and participation in this study.

EXCLUSION CRITERIA:

Preterm labor, preterm PROM, preeclampsia or impaired fetal growth at the time of recruitment.

Any maternal of fetal condition that requires termination of pregnancy.

Known major fetal anomaly or fetal demise.

Active vaginal bleeding.

Multifetal pregnancy with greater than or equal to 3 fetuses.

Serious medical illness (renal insufficiency, congestive heart disease, chronic respiratory insufficiency, etc.).

Severe chronic hypertension (requiring medication).

Asthma requiring systemic steroids.

Patient requiring anti-platelet or non-steroidal anti-inflammatory drugs.

Active hepatitis.

Lack of consent.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340899

Contacts
Contact: Roberto Romero, M.D. (313) 993-2700 romeror@mail.nih.gov

Locations
United States, Michigan
Wiiliam Beaumont Hospital Recruiting
Royal oak, Michigan, United States, 48073
Hutzel Women's Hospital Recruiting
Detroit, Michigan, United States
Australia
Women's and Children's Hospital Recruiting
Adelaide, Australia
Sub-Investigator: Gustaav Dekker, M.D.            
Chile
Sotero del Rio Hospital Recruiting
Puente Alto, Chile
Italy
Padova Hosptial Recruiting
Padova, Italy
Sponsors and Collaborators
  More Information

Study ID Numbers: 999997067, OH97-CH-N067
Study First Received: June 19, 2006
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00340899  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Perinatal Mortality
Perinatal Morbidity
Risk Factors
Pregnancy Complications
Prediction of Outcome

Study placed in the following topic categories:
Pregnancy Complications
Eclampsia
Obstetric Labor, Premature
Obstetric Labor Complications
Pre-Eclampsia
Preeclampsia
Fetal Diseases
Hypertension, Pregnancy-Induced
Growth Disorders
Pregnancy toxemia /hypertension
Fetal Growth Retardation
Premature Birth
Hypertension

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009