Status:
COMPLETED
Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Prenatal Care
Premature Birth
Eligibility:
FEMALE
15-45 years
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 becuas...
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 becaus...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 4 1997
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
19134 Patients enrolled
Trial Details
Trial ID
NCT00340899
Start Date
December 4 1997
End Date
July 13 2017
Last Update
February 24 2023
Active Locations (1)
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1
Sotero del Rio Hospital
Santiago, Chile