Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
1 other identifier
observational
15,926
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2017
CompletedStudy Start
First participant enrolled
August 15, 2017
CompletedFirst Posted
Study publicly available on registry
August 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedApril 27, 2020
August 1, 2017
8 months
August 15, 2017
April 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
study group
pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks
control group
pregnant women without PROM and chorioamnionitis
Eligibility Criteria
The pregnant women who are hospitalized to delivery in the collaborator hospitals.
You may qualify if:
- PROM or chorioamnionitis
- gestational age is ≥ 24 weeks
You may not qualify if:
- gestational age \<24 weeks
- artificial rupture of membrane for labor induction
- natural rupture of membrane during induction before labor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayi Children's Hospital Affiliated to PLA Army General Hospital, Chinalead
- Northwest Women's and Children's Hospital, Xi'an, Shaanxicollaborator
- Chengdu Women's and Children's Central Hospitalcollaborator
- Shenzhen Maternity & Child Healthcare Hospitalcollaborator
- Nanjing Maternity and Child Health Care Hospitalcollaborator
- Shenzhen Bao'an Maternal and Child Health Hospitalcollaborator
- Second Hospital of Jilin Universitycollaborator
Study Sites (6)
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, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xing Li
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
- PRINCIPAL INVESTIGATOR
Shaodong Hua
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
- PRINCIPAL INVESTIGATOR
Jie Cui
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
- PRINCIPAL INVESTIGATOR
Lei Li
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2017
First Posted
August 16, 2017
Study Start
August 15, 2017
Primary Completion
March 31, 2018
Study Completion
April 30, 2018
Last Updated
April 27, 2020
Record last verified: 2017-08