Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uteri… (NCT00340899) | Clinical Trial Compass
CompletedNot Applicable
Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
Chile19,134 participantsStarted 1997-12-04
Plain-language 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.
Who can participate
Age range
15 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Preterm delivery
Timeframe: Ongoing
2
Preeclampsia
Timeframe: Ongoing
3
Intrauterine growth restriction
Timeframe: Ongoing
Trial details
NCT IDNCT00340899
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)