Status:
COMPLETED
Clinical, Biochemical, Histological and Biophysical Parameters in the Prediction of Cerebral Palsy in Patients With Preterm Labor and Premature Rupture of Membranes
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Birth
Pregnancy
Eligibility:
All Genders
Up to 45 years
Brief Summary
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 abnor...
Detailed Description
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 abnor...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Consecutive patients admitted with the diagnosis of preterm labor/contractions or PROM.
- "Preterm labor/contractions" will be defined as:
- gestational age: 20-36 weeks;
- intact membranes; and
- regular uterine contractions greater than or equal to 8 in 60 minutes.
- Preterm PROM will be defined as:
- gestational age 20-36 weeks; and
- 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.
Exclusion
Key Trial Info
Start Date :
December 8 1997
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2014
Estimated Enrollment :
4673 Patients enrolled
Trial Details
Trial ID
NCT00342667
Start Date
December 8 1997
End Date
September 15 2014
Last Update
February 24 2023
Active Locations (5)
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1
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, United States, 20892
2
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
3
Sotero del Rio Hospital
Puente Alto, Chile
4
Ben Gurion University /Soroka Medical Center
Beersheba, Israel