Identification of Microbial DNA in Maternal Plasma After PPROM

Preterm Rupture of Membranes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318470
• Other study ID #: 10-00505-JD
• Status: Completed
• Start date: February 12, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Rupture of Membranes
• Rupture

Intervention

Diagnostic Test:
• mNGS
Metagenomic next generation sequencing for microbial DNA

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of latency	Time between PPROM and delivery	From study enrollment to date of delivery, up to 24 weeks
Secondary	Maternal infectious morbidity	Composite of fever, intrauterine infection, sepsis, postpartum endometritis, surgical site infection, and administration of antibiotics	From study enrollment to date of delivery, up to 30 weeks
Secondary	Neonatal infectious morbidity	Composite of fever, sepsis, administration of antibiotics, and need for blood/urine/cerebrospinal fluid (CSF) cultures	From neonatal birth to neonatal hospital discharge, up to 1 year
Secondary	Histopathological signs of infection	Histopathological signs of infection on routine post-delivery examination of placenta, membranes, and umbilical cord	At time of placental delivery
Secondary	Perinatal demise	Composite of intrauterine fetal demise and neonatal demise	From study enrollment to 28 days of life
Secondary	Admission to neonatal intensive care unit (NICU)		From neonatal birth to neonatal hospital discharge, up to 1 year
Secondary	NICU length of stay		From neonatal birth to neonatal hospital discharge, up to 1 year
Secondary	Neonatal need for supplemental oxygen		From neonatal birth to neonatal hospital discharge, up to 1 year
Secondary	Respiratory distress syndrome		From neonatal birth to neonatal hospital discharge, up to 1 year
Secondary	Necrotizing enterocolitis		From neonatal birth to neonatal hospital discharge, up to 1 year
Secondary	Intraventricular hemorrhage		From neonatal birth to neonatal hospital discharge, up to 1 year