Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
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|ClinicalTrials.gov Identifier: NCT00340899|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : November 13, 2019
|Condition or disease|
|Prenatal Care Premature Birth|
|Study Type :||Observational|
|Actual Enrollment :||19134 participants|
|Official Title:||Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Restriction: A Longitudinal Study|
|Study Start Date :||December 4, 1997|
Pregnant women with gestational age between 6 and 22 weeks
- Preterm delivery [ Time Frame: Ongoing ]Preterm delivery will be classified according to the immediate clinical antecedent of delivery (spontaneous preterm labor with intactmembranes, preterm premature rupture of membranes and pretermdelivery for maternal or fetal indications).
- Preeclampsia [ Time Frame: Ongoing ]Preeclampsia will be defined according to the following criteria:-Systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg on twooccasions greater than or equal to 6 hours apart.-Proteinuria greater than or equal to 300 mg/24 hr or freater than or equal to 2+ (dipstick) on two occasions greater than or equal to 6 hours apart.-The diagnosis of severe preeclampsia will be made in the presence of any of the following: blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 110 (diastolic) on at least two occasions, proteinuria greater than or equal to 5 gr /24 hr, pulmonary edema, thrombocytopenia, oliguria, neurologic symptoms(headache, visual disturbances, persistent hyperreflexia, upperabdominal pain and HELLP syndrome). Eclampsia will be diagnosed if convulsions develop.
- Intrauterine growth restriction [ Time Frame: Ongoing ]Intrauterine growth retardation / small for gestational age infantA small for gestational age fetus will be considered that with a birth weight which is below the 10th percentile for gestational age. Additional cutoffs (5th and 3rd percentile) will also be explored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340899
|United States, Michigan|
|Hutzel Women's Hospital|
|Detroit, Michigan, United States|
|Sotero del Rio Hospital|
|Principal Investigator:||Roberto Romero, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|