Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03251898
Enrollment
15926
Registered
2017-08-16
Start date
2017-08-15
Completion date
2018-04-30
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infection, Premature Rupture of Membrane

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.

Interventions

None listed

Sponsors

Northwest Women's and Children's Hospital, Xi'an, Shaanxi
CollaboratorOTHER
Chengdu Women's and Children's Central Hospital
CollaboratorOTHER
Shenzhen Maternity & Child Healthcare Hospital
CollaboratorOTHER
Nanjing Maternity and Child Health Care Hospital
CollaboratorOTHER
Shenzhen Bao'an Maternal and Child Health Hospital
CollaboratorOTHER
Second Hospital of Jilin University
CollaboratorOTHER
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of early-onset neonatal infections7 days after birthThe incidence of early-onset neonatal infections will be compared between study group and control group.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026