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NCT03251898 Clinical Trial

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

Neonatal Infection Clinical Trial

Official title:
Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03251898
Other study ID # BayiChildrens-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 15, 2017
Est. completion date April 30, 2018

Study information
Verified date August 2017
Source Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 15926
Est. completion date April 30, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Chengdu Women's and Children's Central Hospital Chengdu
China Second Hospital of Jilin University Jilin
China Nanjing Maternity and Child Health Care Hospital Nanjing
China Shenzhen Bao'an Maternal and Child Health Hospital Shenzhen
China Shenzhen Maternity & Child Healthcare Hospital Shenzhen
China Northwest Women's and Children's Hospital Xi'an

Sponsors (7)
Lead Sponsor Collaborator
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China Chengdu Women's and Children's Central Hospital, Nanjing Maternity and Child Health Care Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Second Hospital of Jilin University, Shenzhen Bao'an Maternal and Child Health Hospital, Shenzhen Maternity & Child Healthcare Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of early-onset neonatal infections The incidence of early-onset neonatal infections will be compared between study group and control group. 7 days after birth
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