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

NCT00342667 | Completed

• 2 other identifiers: 999997066OH97-CH-N066
• Study Type: observational
• Target: 4,673
• Locations: 4 countries
• Sites: 5

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 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

Preterm Birth; Pregnancy

Keywords

Pregnancy; Pregnancy Complications; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

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

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.@@@

You may qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (5)

National Institute of Child Health and Human Development (NICHD), 9000 Rockville

Bethesda, Maryland, 20892, United States

Location

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

Location

Sotero del Rio Hospital

Puente Alto, Chile

Location

Ben Gurion University /Soroka Medical Center

Beersheba, Israel

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

• 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.

  PMID: 8592523 BACKGROUND

• 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.

  PMID: 1520012 BACKGROUND

• 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.

  PMID: 8345418 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pregnancy Complications

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Roberto Romero, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 8, 1997
• Primary Completion: September 15, 2014
• Study Completion: September 15, 2014
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

CL (1); IL (1); KR (1); US (2)