NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedN/A

Sponsor: University of Bern

Conditions: Sexually Transmitted Infections (Not HIV or Hepatitis), Premature Birth, Pregnancy; Infection, Microbial Colonization, Chlamydia Trachomatis Infection

Interventions: No intervention

Countries: South Africa

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Locations (1)

East London, Eastern Cape, South Africa