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Identification of Microbial DNA in Maternal Plasma After PPROM

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ClinicalTrials.gov Identifier: NCT04318470
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment
Preterm Rupture of Membranes Diagnostic Test: mNGS

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Using Metagenomic Next-generation Sequencing to Identify Microbial DNA in Maternal Plasma in Cases of Preterm Premature Rupture of Membranes
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
PPROM
Preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks gestation
Diagnostic Test: mNGS
Metagenomic next generation sequencing for microbial DNA

Healthy controls
Gestational-age-matched controls without preterm premature rupture of membranes or other pregnancy complications
Diagnostic Test: mNGS
Metagenomic next generation sequencing for microbial DNA




Primary Outcome Measures :
  1. Length of latency [ Time Frame: From study enrollment to date of delivery, up to 24 weeks ]
    Time between PPROM and delivery


Secondary Outcome Measures :
  1. Maternal infectious morbidity [ 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

  2. Neonatal infectious morbidity [ 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

  3. Histopathological signs of infection [ Time Frame: At time of placental delivery ]
    Histopathological signs of infection on routine post-delivery examination of placenta, membranes, and umbilical cord

  4. Perinatal demise [ Time Frame: From study enrollment to 28 days of life ]
    Composite of intrauterine fetal demise and neonatal demise

  5. Admission to neonatal intensive care unit (NICU) [ Time Frame: From neonatal birth to neonatal hospital discharge, up to 1 year ]
  6. NICU length of stay [ Time Frame: From neonatal birth to neonatal hospital discharge, up to 1 year ]
  7. Neonatal need for supplemental oxygen [ Time Frame: From neonatal birth to neonatal hospital discharge, up to 1 year ]
  8. Respiratory distress syndrome [ Time Frame: From neonatal birth to neonatal hospital discharge, up to 1 year ]
  9. Necrotizing enterocolitis [ Time Frame: From neonatal birth to neonatal hospital discharge, up to 1 year ]
  10. Intraventricular hemorrhage [ Time Frame: From neonatal birth to neonatal hospital discharge, up to 1 year ]

Biospecimen Retention:   Samples With DNA
Maternal plasma


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients with preterm premature rupture of membranes and gestational-age-matched controls
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318470


Contacts
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Contact: Nasim C Sobhani, MD (415) 502-3231 Nasim.Sobhani@UCSF.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Nasim C Sobhani, MD    415-502-3231    Nasim.Sobhani@UCSF.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Nasim C Sobhani, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04318470    
Other Study ID Numbers: 10-00505-JD
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries