Clinical trial NCT00340899: Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
Official title: Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Restriction: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prenatal Care
Premature Birth
Keywords: Perinatal Mortality
Perinatal Morbidity
Preterm Birth
Pregnancy Complications
Pregnancy
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 19134
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending prenatal clinics

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.

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.

Eligibility 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.

Primary outcomes:
measure: Preterm delivery
timeFrame: Ongoing
measure: Preeclampsia
timeFrame: Ongoing
measure: Intrauterine growth restriction
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Sotero del Rio Hospital
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Roberto Romero, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pollack RN, Divon MY. Intrauterine growth retardation: definition, classification, and etiology. Clin Obstet Gynecol. 1992 Mar;35(1):99-107. doi: 10.1097/00003081-199203000-00015. No abstract available.
citation: Romero R, Mazor M, Wu YK, Sirtori M, Oyarzun E, Mitchell MD, Hobbins JC. Infection in the pathogenesis of preterm labor. Semin Perinatol. 1988 Oct;12(4):262-79. No abstract available.
citation: Harding JE, Owens JA, Robinson JS. Should we try to supplement the growth retarded fetus? A cautionary tale. Br J Obstet Gynaecol. 1992 Sep;99(9):707-9. doi: 10.1111/j.1471-0528.1992.tb13866.x. No abstract available.