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

April 23, 2020 updated by: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

15926

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China
        • Chengdu Women's and Children's central hospital
      • Jilin, China
        • Second Hospital of Jilin University
      • Nanjing, China
        • Nanjing Maternity and Child Health Care Hospital
      • Shenzhen, China
        • Shenzhen Bao'an Maternal and Child Health Hospital
      • Shenzhen, China
        • Shenzhen Maternity & Child Healthcare Hospital
      • Xi'an, China
        • Northwest Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The pregnant women who are hospitalized to delivery in the collaborator hospitals.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Chengdu Women's and Children's Central Hospital
Second Hospital of Jilin University
Nanjing Maternity and Child Health Care Hospital
Shenzhen Bao'an Maternal and Child Health Hospital
Shenzhen Maternity & Child Healthcare Hospital
Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BayiChildrens-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonatal Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe