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

Completed

• Conditions: Premature Rupture of Membrane; Neonatal Infection

• Registration Number: NCT03251898
• Lead Sponsor: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-15
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-16
• Primary Completion: 2018-03-31
• Study Completion: 2018-04-30
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15926

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of early-onset neonatal infections	7 days after birth	The incidence of early-onset neonatal infections will be compared between study group and control group.

Trial Locations

Locations (6)

Second Hospital of Jilin University; 🇨🇳 Jilin, China

Chengdu Women's and Children's Central Hospital; 🇨🇳 Chengdu, China

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, China

Shenzhen Maternity & Child Healthcare Hospital; 🇨🇳 Shenzhen, China

Northwest Women's and Children's Hospital; 🇨🇳 Xi'an, China

Shenzhen Bao'an Maternal and Child Health Hospital; 🇨🇳 Shenzhen, China