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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00342667
• Other study ID #: 999997066
• Secondary ID: OH97-CH-N066
• Status: Completed
• Start date: December 8, 1997
• Est. completion date: September 15, 2014

Study information

• Verified date: February 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4673
• Est. completion date: September 15, 2014
• Est. primary completion date: September 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 45 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Fetal Membranes, Premature Rupture
• Obstetric Labor, Premature
• Pregnancy
• Premature Birth
• Preterm Birth
• Rupture

Locations

Country	Name	City	State
Chile	Sotero del Rio Hospital	Puente Alto
Israel	Ben Gurion University /Soroka Medical Center	Beer-Sheva
Korea, Republic of	Seoul National University Hospital	Seoul
United States	National Institute of Child Health and Human Development (NICHD), 9000 Rockville	Bethesda	Maryland
United States	Hutzel Women's Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Chile,  Israel,  Korea, Republic of, 

References & Publications (3)

Cummins SK, Nelson KB, Grether JK, Velie EM. Cerebral palsy in four northern California counties, births 1983 through 1985. J Pediatr. 1993 Aug;123(2):230-7. doi: 10.1016/s0022-3476(05)81693-2. — View Citation

Nelson KB, Dambrosia JM, Ting TY, Grether JK. Uncertain value of electronic fetal monitoring in predicting cerebral palsy. N Engl J Med. 1996 Mar 7;334(10):613-8. doi: 10.1056/NEJM199603073341001. — View Citation

Nicholson A, Alberman E. Cerebral palsy--an increasing contributor to severe mental retardation? Arch Dis Child. 1992 Aug;67(8):1050-5. doi: 10.1136/adc.67.8.1050. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the relationship between these pathologic sub- groups (i.e., intrauterine infection and non infection associated preterm labor/contractions and preterm PROM ) and short and long term neonatal outcome.	Establish the relationship between these pathologic sub- groups (i.e., intrauterine infection and non infection associated preterm labor /contractions and preterm PROM ) and short and long term neonatal outcome.	1. gestational age: 20-36