Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Prenatal Care; Premature Birth

Study type: Observational

Funder types: NIH

Identifiers

NCT00340899

999997067

OH97-CH-N067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19,134 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

19,134 participants in 1 patient group

Pregnant women

Description:

Pregnant women with gestational age between 6 and 22 weeks