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

NCT06131749 | Completed

• 1 other identifier: SNSF197831
• Study Type: observational
• Target: 603
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sexually transmitted infections; Preterm birth; Gestational age at birth; Vaginal microbiome; Genital mycoplasmas; Organism load; Vaginal yeast; Antenatal care

Outcome Measures

Primary Outcomes (1)

• Gestational age at birth

  Gestational age in days, estimated using data from obstetric ultrasound at enrolment visit

  Recorded within 2 weeks of delivery

Secondary Outcomes (4)

• Preterm birth

  Recorded within 2 weeks of birth

• Low birth weight

  Measured within 72 hours of birth

• Miscarriage

  Collected throughout pregnancy until delivery

• Stillbirth

  Collected throughout pregnancy until delivery

Other Outcomes (2)

• Prevalence of microorganisms

  Measured at enrolment visit and at 30-34 week visit

• Incidence of microorganisms

  Measured at 30-34 week visit

Study Arms (1)

Pregnant women

No intervention. Followed during pregnancy at baseline and 30-34 weeks. Followed after delivery at 3-6 days.

Other: No intervention

Interventions

No intervention OTHER

No intervention, observational cohort study

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women receiving antenatal care at one primary health care facility in Buffalo City Metropolitan Municipality, Eastern Cape Province, South Africa.

You may qualify if:

• Living in Buffalo City Metropolitan Municipality
• Intend to deliver in the same municipality
• \<27 weeks of gestation at enrolment, confirmed by ultrasound
• Provide written informed consent

You may not qualify if:

• Participation in any other research study
• Inability to understand and speak a local language (English, Afrikaans, or isiXhosa).

Sponsors & Collaborators

• University of Bern: lead
• Foundation for Professional Development: collaborator
• Utrecht University: collaborator
• University of Pretoria: collaborator
• University of Cape Town: collaborator
• University of Southern California: collaborator
• University of Alabama at Birmingham: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Empilweni Gompo Community Health Centre

East London, Eastern Cape, 5209, South Africa

Location

Related Publications (1)

• Gigi RMS, Mdingi MM, Jung H, Claassen-Weitz S, Butikofer L, Klausner JD, Muzny CA, Taylor CM, van de Wijgert JHHM, Peters RPH, Low N. Genital tract infections, the vaginal microbiome and gestational age at birth among pregnant women in South Africa: a cohort study protocol. BMJ Open. 2023 Dec 28;13(12):e081562. doi: 10.1136/bmjopen-2023-081562.

  PMID: 38154893 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal swabs for on-site testing for Chlamydia trachomatis, Neisseria gonorrhoeae. Swabs discarded after testing Vaginal swabs for PCR detection of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum. Extracted DNA retained after testing Vaginal specimens for microscopy and Nugent scoring. Specimens retained Vaginal swab for 16S ribosomal ribonucleic acid (rRNA) amplicon sequencing. Extracted DNA retained after testing

MeSH Terms

Conditions

Sexually Transmitted Diseases; Hepatitis; Premature Birth; Pregnancy Complications, Infectious; Communicable Diseases; Gonorrhea; Trichomonas Vaginitis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; HIV Infections

Condition Hierarchy (Ancestors)

Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nicola Low, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: March 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)