Clinical, Biochemical, Histological and Biophysical Parameters in the Prediction of Cerebral Palsy in Patients With Preterm Labor and Premature Rupture of Membranes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4673 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-12-08

Study Completion Date

2014-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental disabilities, especially mental retardation. Cerebral palsy is frequently associated with neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have resulted in improved survival of very low birthweight infants but also in an increased frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two thirds of preterm neonates are born to mothers with preterm labor with intact membranes or preterm premature rupture of membranes. A growing body of evidence suggests that these conditions are heterogeneous. This is an observational cohort study designed to identify the mechanisms of disease in patients with preterm labor/contractions and preterm premature rupture of membranes and to describe the relationship between clinical, biochemical, histological, biophysical parameters and the development of infant neurological disorders.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Movements as a Predictor of Future Developmental Delay

NCT00418808

Cerebral Palsy Premature Birth

UNKNOWN

Inflammatory Cytokines Associated With Perinatal Brain Injury

NCT01035697

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +2 more

COMPLETED

Cerebral Function Monitoring in Premature Infants

NCT00873847

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +2 more

COMPLETED

Perinatal Stroke: Understanding Brain Reorganization

NCT02743728

Stroke Hemiparesis

COMPLETED

Study of Generalized Movements for Early Prediction of Cerebral Palsy

NCT00749008

Cerebral Palsy Prematurity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental disabilities, especially mental retardation. Cerebral palsy is frequently associated with neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have resulted in improved survival of very low birthweight infants but also in an increased frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two thirds of preterm neonates are born to mothers with preterm labor with intact membranes or preterm premature rupture of membranes. A growing body of evidence suggests that these conditions are heterogeneous. This is an observational cohort study designed to identify the mechanisms of disease in patients with preterm labor/contractions and preterm premature rupture of membranes and to describe the relationship between clinical, biochemical, histological, biophysical parameters and the development of infant neurological disorders.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

patients with preterm labor/contractions and preterm premature rupture of membranes

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Consecutive patients admitted with the diagnosis of preterm labor/contractions or PROM.

"Preterm labor/contractions" will be defined as:

1. gestational age: 20-36 weeks;
2. intact membranes; and
3. regular uterine contractions greater than or equal to 8 in 60 minutes.

Preterm PROM will be defined as:

1. gestational age 20-36 weeks; and
2. spontaneous rupture of membranes as diagnosed by sterile speculum examination confirming pooling of amniotic fluid in the vagina, a positive Nitrazine test result, and a positive ferning test result. In cases of suspected but unconfirmed preterm PROM, indigo carmin instillation will be performed. The vaginal leakage of indigo carmin will confirm the diagnosis in these cases.

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No