NCT03251898

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

Completed Last updated 27 April 2020

What this trial tests

trial in Premature Rupture of Membrane in 15,926 participants. Completed in 30 April 2018.

Timeline

15 August 2017

Primary endpoint
31 March 2018

30 April 2018

Quick facts

Lead sponsor	Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Status	Completed
Study type	OBSERVATIONAL
Enrollment	15,926
Start date	15 August 2017
Primary completion	31 March 2018
Estimated completion	30 April 2018
Sites	6 locations across China

Conditions studied

• Premature Rupture of Membrane — all drugs for Premature Rupture of Membrane →
• Neonatal Infection — all drugs for Neonatal Infection →

Sponsor

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

Who can join

Eligibility, female only, with Premature Rupture of Membrane or Neonatal Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The correlation between prelabour rupture of the membranes and neonatal infectious diseases, and the evaluation of guideline implementation in China: a multi-centre prospective cohort study.
   Zhuang L, Li ZK, Zhu YF, Ju R, et al · · 2020 · cited 19× · PMID 34327382 · DOI 10.1016/j.lanwpc.2020.100029
2. Latency period of PROM at term and the risk of neonatal infectious diseases.
   Zhuang L, Li ZK, Zhu YF, Ju R, et al · · 2022 · cited 7× · PMID 35851306 · DOI 10.1038/s41598-022-16593-6
3. Predicting risk of severe neonatal outcomes in preterm infants born from mother with prelabor rupture of membranes.
   Zhuang L, Li ZK, Zhu YF, Ju R, et al · · 2022 · PMID 35787798 · DOI 10.1186/s12884-022-04855-0