Microbiome And Multi'Omics In Preterm Birth: The Bacteria And Birth Study

NCT02392650 | Unknown

• 1 other identifier: H-34056
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 1

Brief Summary

Hominids and hominins serve as remarkable hosts to microbes, and we have co-evolved over the past 4.5 million years as highly plethoric communities. Human-associated microorganisms (the "microbiome") are present in numbers exceeding the quantities of human cells by at least 10-fold beginning in the neonatal period. The collective genome (the "metagenome") exceeds our human genome in terms of gene content by more than 150-fold. With respect to microbiota and preterm birth, it has generally assumed that the majority of intrauterine infections originate in the lower genital tract, with microbiota ascending into the otherwise sterile intrauterine environment to infect the placenta (preterm birth), fetal membranes (chorioamnionitis), umbilical cord (funisitis), and the fetus (sepsis). However, we and others have recently demonstrated that the vaginal and gut microbiome communities are distinctly structured in pregnancy, and the placenta is in fact not sterile, but rather harbors a low-abundance microbiome which is likely acquired through hematogenous transmission of the oral microbiome. Based on our prior studies and preliminary data, our central hypothesis is that a distinct and largely commensal resident microbiome in pregnancy renders risk for preterm birth. By utilizing our state-of-the-science technology and analysis tools in a longitudinal case-cohort of preterm birth subjects, we will be able to transform "discovery based" metagenomics and multi'omics science into readily translatable mechanistic studies at a previously unparalleled level.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (2)

• Characterization of Maternal-Fetal microbiome

  Longitudinally characterize the maternal, placental, and infant microbiome in a cohort at risk of preterm birth. Not all the women will ultimately deliver preterm; we we will be able to see if there are microbiome changes associated with preterm birth.

  Conception to 4-6 weeks postpartum

• Association of maternal microbiome (gut, oral, vaginal, placenta) with preterm birth

  Longitudinally characterize the maternal, placental, and infant microbiome in a cohort at risk of preterm birth. Not all the women will ultimately deliver preterm; we we will be able to see if there are microbiome changes associated with preterm birth.

  Conception to 4-6 weeks postpartum

Secondary Outcomes (2)

• Rate of Preterm Birth

  Conception to date of date of delivery, <37 weeks

• Rate of Term Birth

  Conception to date of date of delivery

Eligibility Criteria

• Age: 16 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who are currently pregnant who are at high risk for preterm birth; Pregnant with one baby (not twins or triplets) and who attend regular prenatal visits. They will spend an extra 20 minutes at 5-6 priority scheduled visits to obtain study samples and complete questionnaires, with the last visit occurring around 6 weeks after delivery.

You may qualify if:

• Gravidae at risk for preterm birth, defined as: History of prior spontaneous preterm birth at 16w0d-36w6d gestational age confirmed by review of medical records. If efforts to retrieve medical records are unsuccessful, eligibility will depend upon the events surrounding the prior birth and birthweight under 2 kg; Documented shortened cervix \<2.5 cm by transvaginal ultrasound performed by experienced sonographer at \<24 weeks gestational age; Documented and culture-proven complicated lower or upper urinary tract infection defined as a urinary tract infection requiring hospitalization (e.g., pyelonephritis); Documented periodontal disease, treated or untreated; Documented recurrent lower genital infection; Smoking or other chemical dependency that would convey an increased risk of preterm birth; Other clinical concern for high risk of preterm birth (and cleared by PI Dr. Aagaard at BCM or Dr. Saade at UTMB)
• Enrollment at less than or equal to 20 weeks gestation by best obstetrical estimate
• Able to speak English or work with an interpreter
• Cognitively aware enough to be able to participate in the study
• Gravidae with viable pregnancy \>10 weeks gestational age
• Willingness to consent to all required aspects of protocol - There will be additional non-required aspects that we will recruit 20% of subjects to participate in. These will be voluntary opt-in aspects
• years of age or older

You may not qualify if:

• Multifetal gestation at any time during the pregnancy
• Known HIV or Hepatitis C infection
• Known immunosuppressive disease
• Use of any of the following drugs within the last 6 months; Cytokines; Methotrexate or immunosuppressive cytotoxic agents
• History of cancer except for squamous or basal cell carcinomas of the skin or thyroid cancer that have been managed and fully treated.
• Major surgery of the GI tract (including gastric bypass), with the exception of cholecystectomy and appendectomy in the past five years. Any major bowel resection at any time. If conditions arise that require such surgeries during participation in the study, subjects will not be excluded after enrollment. If patient develops need for such surgery after enrollment, they will not be excluded.
• Documented chronic GI disorders, (e.g., Crohn's diseae)
• Chronic conditions with GI symptoms, (e.g. cystic fibrosis)
• Autism spectrum disorder or significant developmental delay, psychosis, major depressive disorder, or a history of bipolar disorder if there is concern about ability to consent
• Treatment for or suspicion of ever having had toxic shock syndrome.
• Fatal fetal anomaly. Will exclude after enrollment if not previously identified

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The University of Texas Medical Branch, Galveston: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA, RNA and metabolites

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Kjersti Aagaard, MD/PhD

  Associate Professor / Vice Chair for Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Maternal-Fetal Medicine and Vice Chair for Research at Baylor College of Medicine

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 19, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

US (1)