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NCT Number: NCT03251898

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.

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Key information

Conditions

Premature Rupture of Membrane Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Neonatal Infection Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Chengdu Women's and Children's Central Hospital, Chengdu, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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