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

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

Status: Completed

Conditions: Premature Rupture of Membrane; Neonatal Infection

Study type: Observational

Funder types: Other

Identifiers

NCT03251898

BayiChildrens-01

Details and patient eligibility

About

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.

Enrollment: 15,926 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

15,926 participants in 2 patient groups

study group

Description:

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

control group

Description:

pregnant women without PROM and chorioamnionitis