Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
- Enrollment
- 15,926
- Locations
- 6
- Primary Endpoint
- the incidence of early-onset neonatal infections
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
the incidence of early-onset neonatal infections
Time Frame: 7 days after birth
The incidence of early-onset neonatal infections will be compared between study group and control group.
Secondary Outcomes
No secondary outcomes reported