Clinical, Biochemical, Histological and Biophysical Parameters in the Prediction of Cerebral Palsy in Patients With Preterm Labor and Premature Rupture of Membranes
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Women's Studies |
| Therapuetic Areas: | Neurology, Reproductive |
| Healthy: | No |
| Age Range: | 15 - 45 |
| Updated: | 11/21/2018 |
| Start Date: | December 8, 1997 |
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.
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.
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.
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.
- 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.
We found this trial at
2
sites
Bethesda, Maryland 20892
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