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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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