Clinical trial NCT03251898: Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
Official title: Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Rupture of Membrane
Neonatal Infection
Lead sponsor: Seventh Medical Center of PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: Chengdu Women's and Children's Central Hospital
name: Shenzhen Maternity & Child Healthcare Hospital
name: Nanjing Maternity and Child Health Care Hospital
name: Shenzhen Bao'an Maternal and Child Health Hospital
name: Second Hospital of Jilin University
First posted: 2017-08-16
Enrollment: 15926
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The pregnant women who are hospitalized to delivery in the collaborator hospitals.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: the incidence of early-onset neonatal infections
timeFrame: 7 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
city: Jilin
country: China
facility: Second Hospital of Jilin University
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
city: Shenzhen
country: China
facility: Shenzhen Bao'an Maternal and Child Health Hospital
city: Shenzhen
country: China
facility: Shenzhen Maternity & Child Healthcare Hospital
city: Xi'an
country: China
facility: Northwest Women's and Children's Hospital
Study officials:
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
name: Xing Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
name: Shaodong Hua
role: PRINCIPAL_INVESTIGATOR
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
name: Jie Cui
role: PRINCIPAL_INVESTIGATOR
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
name: Lei Li
role: PRINCIPAL_INVESTIGATOR
References: