Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa

Summary

This cohort study plans to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.

The study enrols pregnant women at one public health care facility in East London, South Africa. At enrolment and 30-34 weeks of pregnancy, participants provide swabs for testing for sexually transmitted infections, vaginal yeasts and genital mycoplasmas; for microscopy and Nugent scoring; and for 16S ribosomal ribonucleic acid gene sequencing and quantification. The primary outcome is gestational age at birth.

Statistical analyses include: regression modelling to explore associations between specific microorganisms (including microbiota) and gestational age at birth; construction of an index of vaginal inflammation, using data about microorganism load and inflammatory potential; classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth.

Conditions

• Sexually Transmitted Infections (Not HIV or Hepatitis)
• Premature Birth
• Pregnancy; Infection
• Microbial Colonization
• Chlamydia Trachomatis Infection
• Neisseria Gonorrheae Infection
• Trichomonas Vaginitis
• Mycoplasma Genitalium Infection
• Bacterial Vaginosis
• Vaginal Candida
• Ureaplasma Urealyticum Infection
• Genital Mycoplasma Infection
• HIV Infections

Interventions

OTHER

No intervention

No intervention, observational cohort study

Sponsors & Collaborators

• Foundation for Professional Development

  collaborator UNKNOWN

• Utrecht University

  collaborator OTHER

• University of Pretoria

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• University of Bern

  lead OTHER

Principal Investigators

• Nicola Low, MD · University of Bern

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2024-04-30

Completion

2024-07-31

Countries

• South Africa

Study Locations