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

Completed

• Conditions: Prenatal Care; Premature Birth

• Registration Number: NCT00340899
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Timeline

• Study Start: 1997-12-04
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-21
• Primary Completion: 2017-07-03
• Study Completion: 2017-07-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrauterine growth restriction	Ongoing	Intrauterine growth retardation / small for gestational age infantA small for gestational age fetus will be considered that with a birth weight which is below the 10th percentile for gestational age. Additional cutoffs (5th and 3rd percentile) will also be explored.
Preterm delivery	Ongoing	Preterm delivery will be classified according to the immediate clinical antecedent of delivery (spontaneous preterm labor with intactmembranes, preterm premature rupture of membranes and pretermdelivery for maternal or fetal indications).
Preeclampsia	Ongoing	Preeclampsia will be defined according to the following criteria:-Systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg on twooccasions greater than or equal to 6 hours apart.-Proteinuria greater than or equal to 300 mg/24 hr or freater than or equal to 2+ (dipstick) on two occasions greater than or equal to 6 hours apart.-The diagnosis of severe preeclampsia will be made in the presence of any of the following: blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 110 (diastolic) on at least two occasions, proteinuria greater than or equal to 5 gr /24 hr, pulmonary edema, thrombocytopenia, oliguria, neurologic symptoms(headache, visual disturbances, persistent hyperreflexia, upperabdominal pain and HELLP syndrome). Eclampsia will be diagnosed if convulsions develop.

Trial Locations

Locations (1)

Sotero del Rio Hospital; 🇨🇱 Santiago, Chile