Identification of Microbial DNA in Maternal Plasma After PPROM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the use of metagenomic next generation sequencing in identifying microbial DNA in plasma samples of patients with preterm premature rupture of membranes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predicting EONS in PPROM Patients

NCT03819192

PPROM Early-Onset Neonatal Sepsis

UNKNOWN

Maternal Gut Microbiome (MGM) Study of Diet, the Gut Microbiome and Preterm Birth

NCT02560246

Preterm Birth

COMPLETED

Genomic Sequencing in Anatomically Normal Fetuses

NCT06211348

Pregnant Individuals Requesting Standard Microarray

RECRUITING NA

PROMComplete for Determination of Rupture of Fetal Membranes

NCT02369601

Fetal Membranes, Premature Rupture

UNKNOWN

Development of an Optimal Approach to Return of Results for Next-generation Sequencing for Prenatal Diagnosis

NCT02255825

Major Fetal Anomaly

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although preterm premature rupture of membranes (PPROM) occurs in only 3% of pregnancies, it accounts for 30% of preterm births (PTB) and is associated with serious maternal and neonatal morbidity. An important factor in the underlying pathophysiology of PPROM and subsequent PTB is subclinical infection, which promotes a cascade of events that contribute to synthesis of prostaglandins, release of proinflammatory cytokines, infiltration of neutrophils, and activation of metalloproteases. Over time, enhanced activity of these infectious and inflammatory pathways contributes to the development of spontaneous labor and/or overt intraamniotic infection (IAI). Unfortunately, the majority of patients with PPROM do not manifest signs and symptoms of infection that are detectable by clinical examination, laboratory evaluation, and traditional microdiagnostic tests, and attempting to predict length of latency period and/or timing of delivery remains a clinical challenge. We propose the use of metagenomic next-generation sequencing (mNGS) to identify microbial DNA in maternal plasma following PPROM. We hypothesize that the presence and abundance of microbial DNA is associated with a shorter latency period and that an increase in the abundance of microbial DNA precedes delivery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Rupture of Membranes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PPROM

Preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks gestation

mNGS

Intervention Type DIAGNOSTIC_TEST

Metagenomic next generation sequencing for microbial DNA

Healthy controls

Gestational-age-matched controls without preterm premature rupture of membranes or other pregnancy complications

mNGS

Intervention Type DIAGNOSTIC_TEST

Metagenomic next generation sequencing for microbial DNA

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mNGS

Metagenomic next generation sequencing for microbial DNA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* For PPROM group, preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks of gestation
* For control group, healthy pregnancy with no evidence of preterm premature rupture of membranes or other major complications