Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
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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 |
| Study Type: | Observational |
| Official Title: | Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Restriction: A Longitudinal Study |
| Estimated Enrollment: | 27778 |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- 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.
Contacts and Locations| Contact: Roberto Romero, M.D. | (313) 993-2700 | romeror@mail.nih.gov |
| United States, Michigan | |
| Hutzel Women's Hospital | Recruiting |
| Detroit, Michigan, United States | |
| Wiiliam Beaumont Hospital | Recruiting |
| Royal oak, Michigan, United States, 48073 | |
| Australia | |
| Women's and Children's Hospital | Recruiting |
| Adelaide, Australia | |
| Contact: Dekker Gustaav, M.D. Not Listed | |
| Chile | |
| Sotero del Rio Hospital | Recruiting |
| Santiago, Chile | |
| Italy | |
| Azienda Ospedale/Universita', Obstetrics/Gynecology Unit | Recruiting |
| Padova, Italy | |
| Korea, Republic of | |
| Seoul National University | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Yoon Bo Hyun, M.D. Not Listed | |
| Principal Investigator: | Roberto Romero, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00340899 History of Changes |
| Other Study ID Numbers: | 999997067, OH97-CH-N067 |
| Study First Received: | June 19, 2006 |
| Last Updated: | December 19, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Fetal Growth Retardation Pre-Eclampsia Premature Birth Fetal Diseases Pregnancy Complications |
Growth Disorders Pathologic Processes Hypertension, Pregnancy-Induced Obstetric Labor, Premature Obstetric Labor Complications |
ClinicalTrials.gov processed this record on May 19, 2013