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. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340899
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: December 2013

June 19, 2006
March 14, 2014
December 1997
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Preterm delivery less than 37, less than 35, and less than 32 weeks.
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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
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Maternal Fetal Factors
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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 name 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 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.

Both
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Yes
Contact: Roberto Romero, M.D. (313) 993-2700 romeror@mail.nih.gov
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)
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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)
December 2013

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