Identification of Microbial DNA in Maternal Plasma After PPROM

NCT04318470 | Completed

• 1 other identifier: 10-00505-JD
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Rupture of Membranes

Outcome Measures

Primary Outcomes (1)

• Length of latency

  Time between PPROM and delivery

  From study enrollment to date of delivery, up to 24 weeks

Secondary Outcomes (10)

• Maternal infectious morbidity

  From study enrollment to date of delivery, up to 30 weeks

• Neonatal infectious morbidity

  From neonatal birth to neonatal hospital discharge, up to 1 year

• Histopathological signs of infection

  At time of placental delivery

• Perinatal demise

  From study enrollment to 28 days of life

• Admission to neonatal intensive care unit (NICU)

  From neonatal birth to neonatal hospital discharge, up to 1 year

Study Arms (2)

PPROM

Preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks gestation

Diagnostic Test: mNGS

Healthy controls

Gestational-age-matched controls without preterm premature rupture of membranes or other pregnancy complications

Diagnostic Test: mNGS

Interventions

mNGS DIAGNOSTIC_TEST

Metagenomic next generation sequencing for microbial DNA

Healthy controls; PPROM

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients with preterm premature rupture of membranes and gestational-age-matched controls

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal plasma

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nasim C Sobhani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 24, 2020
• Study Start: February 12, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)