Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections

NCT ID: NCT03251898

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15926 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-15

Study Completion Date

2018-04-30

Brief Summary

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This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns. The objective of this study is to analyze the correlation between PROM and early-onset neonatal infections and to assess the prognosis of newborns. A cohort study is designed to implement the study. The subjects of study group are pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are pregnant women without PROM and chorioamnionitis. Control group and research group are paired at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal infections. (3) The pathogenesis of intrauterine infection and neonatal infection.

Detailed Description

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Conditions

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Premature Rupture of Membrane Neonatal Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks

No interventions assigned to this group

control group

pregnant women without PROM and chorioamnionitis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* PROM or chorioamnionitis
* gestational age is ≥ 24 weeks

Exclusion Criteria

* gestational age \<24 weeks
* artificial rupture of membrane for labor induction
* natural rupture of membrane during induction before labor
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwest Women's and Children's Hospital, Xi'an, Shaanxi

OTHER

Sponsor Role collaborator

Chengdu Women's and Children's Central Hospital

OTHER

Sponsor Role collaborator

Shenzhen Maternity & Child Healthcare Hospital

OTHER

Sponsor Role collaborator

Nanjing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Shenzhen Bao'an Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xing Li

Role: PRINCIPAL_INVESTIGATOR

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Shaodong Hua

Role: PRINCIPAL_INVESTIGATOR

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Jie Cui

Role: PRINCIPAL_INVESTIGATOR

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Lei Li

Role: PRINCIPAL_INVESTIGATOR

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Locations

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Chengdu Women's and Children's Central Hospital

Chengdu, , China

Site Status

Second Hospital of Jilin University

Jilin, , China

Site Status

Nanjing Maternity and Child Health Care Hospital

Nanjing, , China

Site Status

Shenzhen Bao'an Maternal and Child Health Hospital

Shenzhen, , China

Site Status

Shenzhen Maternity & Child Healthcare Hospital

Shenzhen, , China

Site Status

Northwest Women's and Children's Hospital

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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BayiChildrens-01

Identifier Type: -

Identifier Source: org_study_id

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