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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00340899
First received: June 19, 2006
Last updated: November 1, 2016
Last verified: October 2016

June 19, 2006
November 1, 2016
December 1997
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  • Preterm delivery [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Preeclampsia [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Intrauterine growth restriction [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00340899 on ClinicalTrials.gov Archive Site
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Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Restriction: A Longitudinal Study
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.
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.
Observational
Time Perspective: Prospective
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  • Prenatal Care
  • Premature Birth
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
27778
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  • INCLUSION CRITERIA:
  • Gestational age between 6 and 22 weeks for the first visit based on the patient s last menstrual period as reported by the patient.
  • 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 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 each 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 or 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.
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
Australia,   Chile,   Italy,   Korea, Republic of
 
NCT00340899
999997067, OH97-CH-N067
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP