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Completed

NCT Number: NCT04318470

Identification of Microbial DNA in Maternal Plasma After PPROM

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mNGS

Diagnostic Test

Metagenomic next generation sequencing for microbial DNA

Primary outcomes

  1. Length of latency

    Time frame: From study enrollment to date of delivery, up to 24 weeks

    Time between PPROM and delivery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Using Metagenomic Next-generation Sequencing to Identify Microbial DNA in Maternal Plasma in Cases of Preterm Premature Rupture of Membranes

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2020
Registry last updated
Apr 7, 2023

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.

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