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

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.

- 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.