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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
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) )

Brief Summary:
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 or disease
Prenatal Care Premature Birth

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 19134 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Pregnant women
Pregnant women with gestational age between 6 and 22 weeks



Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women attending prenatal clinics
Criteria
  • 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.

Information from the National Library of Medicine

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


Locations
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United States, Michigan
Hutzel Women's Hospital
Detroit, Michigan, United States
Chile
Sotero del Rio Hospital
Santiago, Chile
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications:
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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00340899     History of Changes
Other Study ID Numbers: 999997067
OH97-CH-N067
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: October 24, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Perinatal Mortality
Perinatal Morbidity
Preterm Birth
Pregnancy Complications
Pregnancy
Additional relevant MeSH terms:
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Premature Birth
Pre-Eclampsia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hypertension, Pregnancy-Induced