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CompletedNCT03251898Updated Apr 27, 2020

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

An observational study in Premature Rupture of Membrane and Neonatal Infection, sponsored by Bayi Children's Hospital Affiliated to PLA Army General Hospital, China. Completed at 6 sites in China. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-27.

Sponsored by Bayi Children's Hospital Affiliated to PLA Army General Hospital, China · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15,926
Sex
Female
01

Study 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.

02

Conditions studied

  • Premature Rupture of Membrane
  • Neonatal Infection
03

In context

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

This study's enrollment of 15,926 is above the median of 122 across 36 observational studies indexed under Fetal Membranes, Premature Rupture.

Browse Fetal Membranes, Premature Rupture studies →

Lead sponsor

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • PROM or chorioamnionitis
  • gestational age is ≥ 24 weeks

Exclusion criteria

Exclusion Criteria:

  • gestational age \<24 weeks
  • artificial rupture of membrane for labor induction
  • natural rupture of membrane during induction before labor
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15,926 participants (actual)
Target follow-up
3 Weeks
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: 7 days after birth

07

Study locations

6 sites
  • 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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Mar 2018, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2017
First posted
Aug 16, 2017
StartActual
Aug 15, 2017
Primary completionActual
Mar 31, 2018
CompletionActual
Apr 30, 2018
Last update
Apr 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03251898
Lead sponsor
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Collaborators
Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Chengdu Women's and Children's Central Hospital, Shenzhen Maternity & Child Healthcare Hospital, Nanjing Maternity and Child Health Care Hospital, Shenzhen Bao'an Maternal and Child Health Hospital, Second Hospital of Jilin University
Responsible party
Sponsor
First posted
Aug 16, 2017
Start date
Aug 15, 2017
Primary completion
Mar 31, 2018
Completion
Apr 30, 2018
Last update
Apr 27, 2020

Study contacts

Xing Li
principal investigator · Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Shaodong Hua
principal investigator · Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Jie Cui
principal investigator · Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Lei Li
principal investigator · Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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