Clinical, Biochemical, Histological and Biophysical Param... | NCT00342667

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

NCT00342667

Sponsor

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

Status

Completed

Last Update Posted

Feb 24, 2023Actual

Enrollment

4,673Actual

Phase

Not provided

Conditions

Preterm Birth
Pregnancy

Interventions

Not provided

Countries

United States
Chile
Israel
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
OH97-CH-N066

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 1997Actual

Primary Completion Date

Sep 15, 2014Actual

Completion Date

Sep 15, 2014Actual

First Submitted Date

Jun 19, 2006

First Submission Date that Met QC Criteria

Jun 19, 2006

First Posted Date

Jun 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 24, 2023Actual

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,673Actual

Label	Type	Description	Intervention Names
1		patients with preterm labor/contractions and preterm premature rupture of membranes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

45 Years

Standard Ages

ChildAdult

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.@@@

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberto Romero, M.D.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Child Health and Human Development (NICHD), 9000 Rockville		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8592523	Background	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.
1520012	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.

ID	Term
D047928	Premature Birth
D011248	Pregnancy Complications

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases