Sexually Transmitted Infections (Not HIV or Hepatitis)NCT06131749
Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
An observational study of Sexually Transmitted Infections (Not HIV or Hepatitis) and Premature Birth, run by University of Bern at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexually Transmitted Infections (Not HIV or Hepatitis), Premature Birth, Pregnancy; Infection
- How many people
- 603 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Mar 2021to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women receiving antenatal care at one primary health care facility in Buffalo City Metropolitan Municipality, Eastern Cape Province, South Africa.
Who may be able to join
- 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
Who cannot join
- Participation in any other research study
- Inability to understand and speak a local language (English, Afrikaans, or isiXhosa).
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Empilweni Gompo Community Health Centre
East London, Eastern Cape, 5209
About this study
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.
Read the detailed description
Background: Preterm birth complications are the most common cause of death in children under 5 years. In South Africa, the prevalence of both genital tract infections and adverse pregnancy outcomes are high. This study takes a holistic approach, investigating both the presence and quantity of multiple lower genital tract microorganisms, including vaginal microbiota, in pregnancy and their associations with gestational age at birth. Specific objectives are to explore: (1) the association between the presence of specific lower genital tract microorganisms and gestational age at birth (primary outcome), as well as secondary adverse pregnancy outcomes; (2) the association between quantified load of vaginal and sexually transmitted microorganisms and gestational age at birth (primary outcome) as well as secondary adverse pregnancy outcomes; and (3) the combinations of microorganisms that are most strongly associated with earlier gestational age at birth.
Methods: This prospective closed cohort study follows women enrolled during pregnancy until after they give birth. This cohort study is part of a larger project, called Philani Ndiphile (meaning 'be healthy and I will be healthy' in isiXhosa).
A trained study field worker checks for eligibility and obtains written informed consent. A study nurse performs an abdominal ultrasound to estimate the gestational age and confirm eligibility.
At the enrolment visit and a follow-up visit at 30-34 weeks, a study nurse collects vaginal specimens for: on-site testing for Chlamydia trachomatis and Neisseria gonorrhoeae (with antibiotic treatment if positive); and offsite testing for: Nugent scoring; detection and quantification of Mycoplasma genitalium, M. hominis, Ureaplasma. parvum, U. Urealyticum, Trichomonas vaginalis, Candida spp. and 16S rRNA amplicon sequencing for vaginal microbiota analyses.
At a post-natal visit, 3-6 days after giving birth, a study nurse collects information about the birth outcome.
Statistical analyses include:
Objective 1. a) univariable and multivariable regression analyses for associations between specific microorganisms and gestational age at birth. b) compositional multivariable analysis methods to analyse individual taxon relative abundances and mixed effects models to assess associations between pregnancy outcome and vaginal microbiota diversity, vaginal microbiota types and absolute abundances of predefined bacterial groups.
Objective 2. Development of a 'vaginal inflammation index', based on quantification of the vaginal microbiota and their inflammatory potential. This vaginal inflammation index will be analysed as a fixed effect in mixed effects models with pregnancy outcomes.
Objective 3. Classification and regression tree analyses to examine the combination of microorganisms that best predicts 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
- Being tested
- No intervention
- Keywords
- Sexually transmitted infections, Preterm birth, Gestational age at birth, Vaginal microbiome, Genital mycoplasmas, Organism load, Vaginal yeast, Antenatal care
- Medical subject headings
- Sexually Transmitted Diseases, Hepatitis, Premature Birth, Pregnancy Complications, Infectious, Communicable Diseases, Gonorrhea, Trichomonas Vaginitis, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, observational cohort study
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | No intervention. Followed during pregnancy at baseline and 30-34 weeks. Followed after delivery at 3-6 days. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at birth
Gestational age in days, estimated using data from obstetric ultrasound at enrolment visit
Measured: Recorded within 2 weeks of delivery
Secondary outcomes (4)
Preterm birth
Number of babies liveborn before 37 completed weeks of pregnancy, estimated using data from obstetric ultrasound at enrolment visit
Measured: Recorded within 2 weeks of birth
Low birth weight
Number of babies with birth weight <2500g
Measured: Measured within 72 hours of birth
Miscarriage
Number of foetuses delivered dead before 28 completed weeks of pregnancy or with birth weight below 1000g. Gestational age estimated using data from obstetric ultrasound at enrolment visit
Measured: Collected throughout pregnancy until delivery
Stillbirth
Number of foetuses delivered dead at or after 28 completed weeks of pregnancy or with birth weight above 1000g at delivery. Gestational age estimated using data from obstetric ultrasound at enrolment visit
Measured: Collected throughout pregnancy until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Mar 2021
- Primary completion30 Apr 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted Infections (Not HIV or Hepatitis)Studies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Professional Development, Utrecht University, University of Pretoria, University of Cape Town, University of Southern California, University of Alabama at Birmingham, Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Sponsor
- Investigators
- Nicola Low, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131749
- Sponsor's protocol ID
- SNSF197831
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38154893
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
- ClinicalTrials.gov ID
- NCT06131749
- Acronym / sponsor ID
- SNSF197831
- Conditions
- Sexually Transmitted Infections (Not HIV or Hepatitis), Premature Birth, Pregnancy; Infection, Microbial Colonization, Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
- Keywords
- Sexually transmitted infections, Preterm birth, Gestational age at birth, Vaginal microbiome, Genital mycoplasmas, Organism load, Vaginal yeast, Antenatal care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Foundation for Professional Development, Utrecht University, University of Pretoria, University of Cape Town, University of Southern California, University of Alabama at Birmingham, Louisiana State University Health Sciences Center in New Orleans
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Preterm birth complications are the most common cause of death in children under 5 years. In South Africa, the prevalence of both genital tract infections and adverse pregnancy outcomes are high. This study takes a holistic approach, investigating both the presence and quantity of multiple lower genital tract microorganisms, including vaginal microbiota, in pregnancy and their associations with gestational age at birth. Specific objectives are to explore: (1) the association between the presence of specific lower genital tract microorganisms and gestational age at birth (primary outcome), as well as secondary adverse pregnancy outcomes; (2) the association between quantified load of vaginal and sexually transmitted microorganisms and gestational age at birth (primary outcome) as well as secondary adverse pregnancy outcomes; and (3) the combinations of microorganisms that are most strongly associated with earlier gestational age at birth.
Methods: This prospective closed cohort study follows women enrolled during pregnancy until after they give birth. This cohort study is part of a larger project, called Philani Ndiphile (meaning 'be healthy and I will be healthy' in isiXhosa).
A trained study field worker checks for eligibility and obtains written informed consent. A study nurse performs an abdominal ultrasound to estimate the gestational age and confirm eligibility.
At the enrolment visit and a follow-up visit at 30-34 weeks, a study nurse collects vaginal specimens for: on-site testing for Chlamydia trachomatis and Neisseria gonorrhoeae (with antibiotic treatment if positive); and offsite testing for: Nugent scoring; detection and quantification of Mycoplasma genitalium, M. hominis, Ureaplasma. parvum, U. Urealyticum, Trichomonas vaginalis, Candida spp. and 16S rRNA amplicon sequencing for vaginal microbiota analyses.
At a post-natal visit, 3-6 days after giving birth, a study nurse collects information about the birth outcome.
Statistical analyses include:
Objective 1. a) univariable and multivariable regression analyses for associations between specific microorganisms and gestational age at birth. b) compositional multivariable analysis methods to analyse individual taxon relative abundances and mixed effects models to assess associations between pregnancy outcome and vaginal microbiota diversity, vaginal microbiota types and absolute abundances of predefined bacterial groups.
Objective 2. Development of a 'vaginal inflammation index', based on quantification of the vaginal microbiota and their inflammatory potential. This vaginal inflammation index will be analysed as a fixed effect in mixed effects models with pregnancy outcomes.
Objective 3. Classification and regression tree analyses to examine the combination of microorganisms that best predicts earlier gestational age at birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: No interventionNo intervention. Followed during pregnancy at baseline and 30-34 weeks. Followed after delivery at 3-6 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women receiving antenatal care at one primary health care facility in Buffalo City Metropolitan Municipality, Eastern Cape Province, South Africa.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in any other research study
- Inability to understand and speak a local language (English, Afrikaans, or isiXhosa).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention, observational cohort study | Other | Pregnant women |
Primary outcome
Gestational age at birth
Time frame: Recorded within 2 weeks of delivery
Gestational age in days, estimated using data from obstetric ultrasound at enrolment visit
4 secondary outcomes
Preterm birth
Time frame: Recorded within 2 weeks of birth
Low birth weight
Time frame: Measured within 72 hours of birth
Miscarriage
Time frame: Collected throughout pregnancy until delivery
Stillbirth
Time frame: Collected throughout pregnancy until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 38154893Gigi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Low, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Infections (Not HIV or Hepatitis) and Premature Birth, run by University of Bern at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at birth (time frame: Recorded within 2 weeks of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.