University of California, San Francisco
San Francisco, California, 94158, United States
NCT Number: NCT04318470
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.
Looking for future studies?
Notify Me18 year–55 year
Female
Observational
San Francisco, California, 94158, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Metagenomic next generation sequencing for microbial DNA
Time frame: From study enrollment to date of delivery, up to 24 weeks
Time between PPROM and delivery
Time frame: From study enrollment to date of delivery, up to 30 weeks
Composite of fever, intrauterine infection, sepsis, postpartum endometritis, surgical site infection, and administration of antibiotics
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Composite of fever, sepsis, administration of antibiotics, and need for blood/urine/cerebrospinal fluid (CSF) cultures
Time frame: At time of placental delivery
Histopathological signs of infection on routine post-delivery examination of placenta, membranes, and umbilical cord
Time frame: From study enrollment to 28 days of life
Composite of intrauterine fetal demise and neonatal demise
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
University of California, San Francisco
Other
Using Metagenomic Next-generation Sequencing to Identify Microbial DNA in Maternal Plasma in Cases of Preterm Premature Rupture of Membranes
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.
Published trials that share one or more normalized conditions with this study.
NCT04077944
Female Urogenital Diseases and Pregnancy Complications, Fetal Membranes, Premature Rupture
Gaziantep, Turkey (Türkiye)
View Trial DetailsNCT06639919
Female Urogenital Diseases and Pregnancy Complications, Fetal Membranes, Premature Rupture
Yunusemre, Mani̇sa, Turkey (Türkiye)
View Trial DetailsNCT07503184
Dexamethasone, Female Urogenital Diseases and Pregnancy Complications
Multan, Punjab Province, Pakistan
View Trial DetailsNCT06716710
Cardiovascular Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Kocaeli, Turkey (Türkiye)
View Trial Details