Clinical trial NCT04318470: Identification of Microbial DNA in Maternal Plasma After PPROM
Official title: Using Metagenomic Next-generation Sequencing to Identify Microbial DNA in Maternal Plasma in Cases of Preterm Premature Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Rupture of Membranes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients with preterm premature rupture of membranes and gestational-age-matched controls

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* Maternal age \< 18 years
* Major fetal congenital malformation

Primary outcomes:
measure: Length of latency
timeFrame: From study enrollment to date of delivery, up to 24 weeks
Secondary outcomes:
measure: Maternal infectious morbidity
timeFrame: From study enrollment to date of delivery, up to 30 weeks
measure: Neonatal infectious morbidity
timeFrame: From neonatal birth to neonatal hospital discharge, up to 1 year
measure: Histopathological signs of infection
timeFrame: At time of placental delivery
measure: Perinatal demise
timeFrame: From study enrollment to 28 days of life
measure: Admission to neonatal intensive care unit (NICU)
timeFrame: From neonatal birth to neonatal hospital discharge, up to 1 year
measure: NICU length of stay
timeFrame: From neonatal birth to neonatal hospital discharge, up to 1 year
measure: Neonatal need for supplemental oxygen
timeFrame: From neonatal birth to neonatal hospital discharge, up to 1 year
measure: Respiratory distress syndrome
timeFrame: From neonatal birth to neonatal hospital discharge, up to 1 year
measure: Necrotizing enterocolitis
timeFrame: From neonatal birth to neonatal hospital discharge, up to 1 year
measure: Intraventricular hemorrhage
timeFrame: From neonatal birth to neonatal hospital discharge, up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nasim C Sobhani, MD
role: PRINCIPAL_INVESTIGATOR
References: