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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340899
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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.


Condition
Maternal Fetal Factors

Study Type: Observational
Official Title: Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Restriction: A Longitudinal Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Preterm delivery less than 37, less than 35, and less than 32 weeks.

Estimated Enrollment: 27778
Study Start Date: December 1997
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Gestational age between 6 and 22 weeks for the first visit based on the patient s last name 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 either 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 to the 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 of 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340899

Contacts
Contact: Roberto Romero, M.D. (313) 993-2700 romeror@mail.nih.gov

Locations
United States, Michigan
Hutzel Women's Hospital Recruiting
Detroit, Michigan, United States
Wiiliam Beaumont Hospital Recruiting
Royal oak, Michigan, United States, 48073
Australia
Women's and Children's Hospital Recruiting
Adelaide, Australia
Contact: Dekker Gustaav, M.D.    Not Listed      
Chile
Sotero del Rio Hospital Recruiting
Santiago, Chile
Italy
Azienda Ospedale/Universita', Obstetrics/Gynecology Unit Recruiting
Padova, Italy
Korea, Republic of
Seoul National University Recruiting
Seoul, Korea, Republic of
Contact: Yoon Bo Hyun, M.D.    Not Listed      
Sponsors and Collaborators
Investigators
Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00340899     History of Changes
Other Study ID Numbers: 999997067, OH97-CH-N067
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Perinatal Mortality
Perinatal Morbidity
Risk Factors
Pregnancy Complications
Prediction of Outcome

Additional relevant MeSH terms:
Pre-Eclampsia
Premature Birth
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Fetal Diseases
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014