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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00340899 |
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 |
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Maternal Fetal Factors |
Study Type: | Observational |
Official Title: | Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longitudinal Study |
Estimated Enrollment: | 14079 |
Study Start Date: | December 1997 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Contact: Roberto Romero, M.D. | (313) 993-2700 | romeror@mail.nih.gov |
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 |
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 |
Perinatal Mortality Perinatal Morbidity Risk Factors Pregnancy Complications Prediction of Outcome |
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 |
Pathologic Processes |