Neonatal OutcomesNCT07592286
Systematic Screening of Lower Genital Tract Infections
A study testing Enhanced microbiological screening and Standard prenatal care in people with Neonatal Outcomes and Pregnancy Complications, Infectious, run by Universidade Federal do Pampa.
Trial summary
Introduction: The investigation of systematic screening for asymptomatic genital infections in pregnant women is justified by the relevance of these conditions in determining adverse neonatal outcomes, such as prematurity, low birth weight, and perinatal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Neonatal Outcomes, Pregnancy Complications, Infectious, Premature Birth
- What is being tested?
- Enhanced microbiological screening and Standard prenatal care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First-trimester pregnant women.
- Receiving care at the Women's Health service.
- Willingness to participate in the study.
Who cannot join
- #No specific exclusion criteria.
- The study has not started yet and no participants have been enrolled. The term "low-risk" was removed because the study will recruit pregnant women in general
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Systematic Screening of Lower Genital Tract Infections in Pregnant Women for Gestational and Neonatal Outcomes: a Randomized Controlled Trial
Introduction: The investigation of systematic screening for asymptomatic genital infections in pregnant women is justified by the relevance of these conditions in determining adverse neonatal outcomes, such as prematurity, low birth weight, and perinatal morbidity and mortality. Despite its importance, previous studies have shown inconsistent results, largely due to methodological limitations related to sample size, lack of standardized treatment protocols, and insufficient follow-up of pregnant women. There is also divergence among national and international guidelines, which vary between universal and selective recommendations, highlighting gaps in the standardization of clinical practices.
Objectives: To investigate the effectiveness of implementing systematic screening protocol for asymptomatic genital infections in pregnant women in preventing adverse gestational and neonatal outcomes. The specific objectives are: to identify the most prevalent infections in this group; to evaluate the relationship between treatment and the incidence of complications; to compare outcomes between participants assigned to systematic screening and those receiving standard care and to propose recommendations for clinical practice and health policies based on a critical review of the literature and the results obtained.
Read more
Methods: This is a randomized controlled trial that will recruit 250 pregnant women, followed from the first trimester until delivery. Participants will be randomized into two groups: an intervention group, undergoing systematic screening with protocol-guided treatment, and a control group, managed according to current standard care practices, following the municipality's protocol for screening and treatment of genital infections. Primary outcomes include preterm birth, preterm premature rupture of membranes, low birth weight, intra-amniotic infection, puerperal infection, neonatal infection, and fetal and neonatal mortality. Statistical analysis will follow the intention-to-treat principle, and differences in outcomes between groups will be estimated.
Expected Results: This study is expected to provide evidence on whether systematic screening reduces (or does not reduce) maternal and neonatal complications. The randomized controlled trial will be prospectively registered prior to the enrollment of the first participant, in accordance with current ethical standards.
** The study has not started yet and no participants have been enrolled. The term "low-risk" was removed because the study will recruit pregnant women in general
Read the detailed description
This randomized controlled trial will evaluate whether systematic microbiological screening and protocol-based treatment of asymptomatic lower genital tract infections during pregnancy can reduce adverse gestational and neonatal outcomes among low-risk pregnant women.
The study will be conducted in Uruguaiana, a municipality in southern Brazil, within the municipal prenatal care network. Pregnant women receiving care through the Family Health Strategy will be referred to a Women's Health referral service and followed from first-trimester enrollment until delivery. The study is linked to the Graduate Program in Pathology at São Paulo State University "Júlio de Mesquita Filho" (UNESP), Botucatu Medical School.
Participants will be randomized in a 1:1 allocation ratio to either an experimental arm or an active comparator arm. The random allocation sequence will be generated electronically and managed by a designated nursing technician. The physician responsible for clinical care will not have prior access to the allocation sequence, and group assignment will be revealed only after participant enrollment, in order to preserve allocation concealment.
Participants assigned to the experimental arm will undergo enhanced microbiological screening during prenatal follow-up. Vaginal samples will be collected at scheduled prenatal visits for Gram stain-based evaluation of vaginal microbiota. Endocervical samples will be collected once per trimester for real-time polymerase chain reaction detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis. Samples positive for Mycoplasma genitalium will undergo additional analysis for 23S rRNA gene mutations associated with macrolide resistance. Vaginal and cervical infections identified during follow-up will be managed according to a predefined study protocol based on current clinical guidelines.
Participants assigned to the active comparator arm will receive standard prenatal care according to the current municipal clinical protocol. In this group, screening for Chlamydia trachomatis and Neisseria gonorrhoeae will be performed during the first trimester only for pregnant women younger than 30 years, as established by the municipal protocol. Management of vulvovaginal infections will be based on clinical criteria, and treatment will follow the standard municipal protocol.
Study data will be obtained from clinical interviews, biological sample collection, laboratory testing, and review of maternal and neonatal medical records. Clinical interviews will collect sociodemographic, obstetric, and relevant clinical information. Vaginal samples will be analyzed by Gram staining and classified according to predefined microbiological criteria. Endocervical samples will be processed for molecular detection of selected sexually transmitted pathogens. Neonatal and delivery-related outcomes will be collected through review of hospital medical records after delivery at the reference maternity hospital.
All study procedures will be performed by trained personnel in appropriate clinical settings and in accordance with biosafety standards. No additional blood samples will be collected exclusively for research purposes; blood tests will be limited to those routinely performed during prenatal care according to current Brazilian Ministry of Health guidelines.
Participants in both groups will be followed until delivery. The study will compare maternal, obstetric, and neonatal outcomes between the experimental and active comparator groups. Data will be recorded using standardized electronic case report forms and stored in an anonymized electronic database with restricted access to authorized research personnel.
The statistical analysis will follow the intention-to-treat principle, with participants analyzed according to their originally assigned groups, regardless of adherence to the assigned protocol. Categorical variables will be described using absolute and relative frequencies, and continuous variables will be summarized using measures of central tendency and dispersion, as appropriate. Between-group comparisons will be performed using suitable statistical tests according to variable type and distribution. Logistic regression models may be used to estimate the association between the intervention and study outcomes, adjusting for potential confounding variables when applicable. Results will be reported with effect estimates and 95% confidence intervals.
The study will be conducted in accordance with the Declaration of Helsinki and applicable Brazilian regulations for research involving human participants. Written informed consent will be obtained before enrollment. For participants younger than 18 years, written informed consent will be obtained from a legal guardian, and assent will be obtained from the minor participant. Participant confidentiality and data protection will be ensured in accordance with the Brazilian General Data Protection Law.
** The study has not started yet and no participants have been enrolled. The term "low-risk" was removed because the study will recruit pregnant women in general
- Conditions
- Neonatal Outcomes, Pregnancy Complications, Infectious, Premature Birth, Premature Rupture of Fetal Membranes, Pregnancy
- Being tested
- Enhanced microbiological screening, Standard prenatal care
- Keywords
- screening, lower genital tract infections, pregnancy
- Medical subject headings
- Pregnancy Complications, Infectious, Premature Birth, Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced microbiological screeningDiagnostic test
Participants assigned to this intervention will undergo enhanced microbiological screening during prenatal care. Vaginal samples will be collected at all each scheduled prenatal visit for Gram stain-based evaluation, and endocervical samples will be collected once per trimester for real-time PCR detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis. Samples positive for Mycoplasma genitalium will undergo additional analysis for 23S rRNA gene mutations associated with macrolide resistance.
Standard prenatal careOther
Participants assigned to this intervention will receive standard prenatal care according to the current municipal clinical protocol. Screening for Chlamydia trachomatis and Neisseria gonorrhoeae will be performed only during the first trimester and only for pregnant women younger than 30 years. Management of vulvovaginal infections will be based on clinical criteria, and treatment will follow the standard municipal protocol. Participants will be followed at quarterly intervals for data collection until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Enhanced microbiological screening and protocol-based treatment | Experimental | Participants in this arm will undergo enhanced microbiological screening as part of prenatal care. Vaginal samples will be collected at each scheduled prenatal visit for Gram stain-based assessment, and endocervical samples will be collected once per trimester for real-time PCR detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis. Vaginal and cervical infections identified during follow-up will be managed according to the predefined study protocol. Participants will be followed from first-trimester enrollment until delivery. Receives: Diagnostic Test: Enhanced microbiological screening |
| Standard prenatal care according to municipal protocol | Active comparator | Pregnant women in this arm will receive standard prenatal care according to the current municipal clinical protocol. Screening for Chlamydia trachomatis and Neisseria gonorrhoeae will be performed only during the first trimester and only for pregnant women younger than 30 years. Management of vulvovaginal infections will be based on clinical criteria, and treatment will follow the standard municipal protocol. Participants will be followed at quarterly intervals for data collection until delivery. Receives: Other: Standard prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth
Occurrence of preterm birth, defined as delivery before 37 completed weeks of gestation.
Measured: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until 37 completed weeks of gestation, whichever occurs first.
Preterm premature rupture of membranes (PPROM)
From randomization until delivery, assessed up to approximately 22 weeks after randomization or until 37 completed weeks of gestation, whichever occurs first.
Measured: Occurrence of preterm premature rupture of membranes before 37 completed weeks of gestation.
Secondary outcomes (6)
Miscarriage
Occurrence of pregnancy loss before fetal viability, as defined by local clinical criteria, 22 weeks.
Measured: Occurrence of pregnancy loss before fetal viability, defined as spontaneous pregnancy loss before 22 completed weeks of gestation, according to local clinical criteria.
Intra-amniotic infection
Occurrence of clinically diagnosed intra-amniotic infection during pregnancy or labor.
Measured: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Puerperal infection
Occurrence of puerperal infection diagnosed during postpartum hospitalization, based on clinical assessment and/or medical record documentation.
Measured: From delivery until maternal hospital discharge, assessed up to 7 days postpartum.
Neonatal infection
Occurrence of clinically diagnosed neonatal infection during the neonatal hospitalization period, based on clinical assessment and/or medical record documentation.
Measured: From birth until neonatal hospital discharge, assessed up to 28 days of life.
Fetal death
Occurrence of fetal death during pregnancy or at delivery.
Measured: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Neonatal mortality
Occurrence of neonatal death during the neonatal hospitalization period, based on medical record documentation.
Measured: From birth until neonatal hospital discharge, assessed up to 28 days of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neonatal OutcomesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Pampa
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
- Responsible party
- Principal investigator, Rita de Cássia Fossati Silveira Evaldt, Universidade Federal do Pampa
- Investigators
- Marcia da Silva, Dra, Study chair, São Paulo State University (UNESP), Botucatu Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592286
- Sponsor's protocol ID
- RCT Rita
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. Requests for additional information may be evaluated by the study team according to ethical and institutional regulations.
Publications
20. ISSVD - International Society for the Study of Vulvovaginal Disease. Recommendations for the diagnosis and treatment of vaginitis. Journal of Lower Genital Tract Disease, v. 26, n. 1, p. 1-15, 2022.
Carey JC, Klebanoff MA, Hauth JC, Hillier SL, Thom EA, Ernest JM, Heine RP, Nugent RP, Fischer ML, Leveno KJ, Wapner R, Varner M. Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units. N Engl J Med. 2000 Feb 24;342(8):534-40. doi: 10.1056/NEJM200002243420802.
PubMed 10684911Sethi N, Narayanan V, Saaid R, Ahmad Adlan AS, Ngoi ST, Teh CSJ, Hamidi M; WHOW research group. Prevalence, risk factors, and adverse outcomes of bacterial vaginosis among pregnant women: a systematic review. BMC Pregnancy Childbirth. 2025 Jan 20;25(1):40. doi: 10.1186/s12884-025-07144-8.
PubMed 39833700Ng BK, Chuah JN, Cheah FC, Mohamed Ismail NA, Tan GC, Wong KK, Lim PS. Maternal and fetal outcomes of pregnant women with bacterial vaginosis. Front Surg. 2023 Feb 13;10:1084867. doi: 10.3389/fsurg.2023.1084867. eCollection 2023.
PubMed 36860946Kim MJ, Romero R, Gervasi MT, Kim JS, Yoo W, Lee DC, Mittal P, Erez O, Kusanovic JP, Hassan SS, Kim CJ. Widespread microbial invasion of the chorioamniotic membranes is a consequence and not a cause of intra-amniotic infection. Lab Invest. 2009 Aug;89(8):924-36. doi: 10.1038/labinvest.2009.49. Epub 2009 Jun 8.
PubMed 19506551Donders GG, Van Calsteren K, Bellen G, Reybrouck R, Van den Bosch T, Riphagen I, Van Lierde S. Predictive value for preterm birth of abnormal vaginal flora, bacterial vaginosis and aerobic vaginitis during the first trimester of pregnancy. BJOG. 2009 Sep;116(10):1315-24. doi: 10.1111/j.1471-0528.2009.02237.x. Epub 2009 Jun 17.
PubMed 19538417US Preventive Services Task Force; Owens DK, Davidson KW, Krist AH, Barry MJ, Cabana M, Caughey AB, Donahue K, Doubeni CA, Epling JW Jr, Kubik M, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Bacterial Vaginosis in Pregnant Persons to Prevent Preterm Delivery: US Preventive Services Task Force Recommendation Statement. JAMA. 2020 Apr 7;323(13):1286-1292. doi: 10.1001/jama.2020.2684.
PubMed 32259236
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Screening of Lower Genital Tract Infections in Pregnant Women for Gestational and Neonatal Outcomes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07592286
- Acronym / sponsor ID
- RCT Rita
- Conditions
- Neonatal Outcomes, Pregnancy Complications, Infectious, Premature Birth, Premature Rupture of Fetal Membranes, Pregnancy
- Keywords
- screening, lower genital tract infections, pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universidade Federal do PampaUniversity, hospital or other
- Collaborators
- Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 18 May 2026 (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.
Introduction: The investigation of systematic screening for asymptomatic genital infections in pregnant women is justified by the relevance of these conditions in determining adverse neonatal outcomes, such as prematurity, low birth weight, and perinatal morbidity and mortality. Despite its importance, previous studies have shown inconsistent results, largely due to methodological limitations related to sample size, lack of standardized treatment protocols, and insufficient follow-up of pregnant women. There is also divergence among national and international guidelines, which vary between universal and selective recommendations, highlighting gaps in the standardization of clinical practices.
Objectives: To investigate the effectiveness of implementing systematic screening protocol for asymptomatic genital infections in pregnant women in preventing adverse gestational and neonatal outcomes. The specific objectives are: to identify the most prevalent infections in this group; to evaluate the relationship between treatment and the incidence of complications; to compare outcomes between participants assigned to systematic screening and those receiving standard care and to propose recommendations for clinical practice and health policies based on a critical review of the literature and the results obtained.
Methods: This is a randomized controlled trial that will recruit 250 pregnant women, followed from the first trimester until delivery. Participants will be randomized into two groups: an intervention group, undergoing systematic screening with protocol-guided treatment, and a control group, managed according to current standard care practices, following the municipality's protocol for screening and treatment of genital infections. Primary outcomes include preterm birth, preterm premature rupture of membranes, low birth weight, intra-amniotic infection, puerperal infection, neonatal infection, and fetal and neonatal mortality. Statistical analysis will follow the intention-to-treat principle, and differences in outcomes between groups will be estimated.
Expected Results: This study is expected to provide evidence on whether systematic screening reduces (or does not reduce) maternal and neonatal complications. The randomized controlled trial will be prospectively registered prior to the enrollment of the first participant, in accordance with current ethical standards.
** The study has not started yet and no participants have been enrolled. The term "low-risk" was removed because the study will recruit pregnant women in general
Detailed description
This randomized controlled trial will evaluate whether systematic microbiological screening and protocol-based treatment of asymptomatic lower genital tract infections during pregnancy can reduce adverse gestational and neonatal outcomes among low-risk pregnant women.
The study will be conducted in Uruguaiana, a municipality in southern Brazil, within the municipal prenatal care network. Pregnant women receiving care through the Family Health Strategy will be referred to a Women's Health referral service and followed from first-trimester enrollment until delivery. The study is linked to the Graduate Program in Pathology at São Paulo State University "Júlio de Mesquita Filho" (UNESP), Botucatu Medical School.
Participants will be randomized in a 1:1 allocation ratio to either an experimental arm or an active comparator arm. The random allocation sequence will be generated electronically and managed by a designated nursing technician. The physician responsible for clinical care will not have prior access to the allocation sequence, and group assignment will be revealed only after participant enrollment, in order to preserve allocation concealment.
Participants assigned to the experimental arm will undergo enhanced microbiological screening during prenatal follow-up. Vaginal samples will be collected at scheduled prenatal visits for Gram stain-based evaluation of vaginal microbiota. Endocervical samples will be collected once per trimester for real-time polymerase chain reaction detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis. Samples positive for Mycoplasma genitalium will undergo additional analysis for 23S rRNA gene mutations associated with macrolide resistance. Vaginal and cervical infections identified during follow-up will be managed according to a predefined study protocol based on current clinical guidelines.
Participants assigned to the active comparator arm will receive standard prenatal care according to the current municipal clinical protocol. In this group, screening for Chlamydia trachomatis and Neisseria gonorrhoeae will be performed during the first trimester only for pregnant women younger than 30 years, as established by the municipal protocol. Management of vulvovaginal infections will be based on clinical criteria, and treatment will follow the standard municipal protocol.
Study data will be obtained from clinical interviews, biological sample collection, laboratory testing, and review of maternal and neonatal medical records. Clinical interviews will collect sociodemographic, obstetric, and relevant clinical information. Vaginal samples will be analyzed by Gram staining and classified according to predefined microbiological criteria. Endocervical samples will be processed for molecular detection of selected sexually transmitted pathogens. Neonatal and delivery-related outcomes will be collected through review of hospital medical records after delivery at the reference maternity hospital.
All study procedures will be performed by trained personnel in appropriate clinical settings and in accordance with biosafety standards. No additional blood samples will be collected exclusively for research purposes; blood tests will be limited to those routinely performed during prenatal care according to current Brazilian Ministry of Health guidelines.
Participants in both groups will be followed until delivery. The study will compare maternal, obstetric, and neonatal outcomes between the experimental and active comparator groups. Data will be recorded using standardized electronic case report forms and stored in an anonymized electronic database with restricted access to authorized research personnel.
The statistical analysis will follow the intention-to-treat principle, with participants analyzed according to their originally assigned groups, regardless of adherence to the assigned protocol. Categorical variables will be described using absolute and relative frequencies, and continuous variables will be summarized using measures of central tendency and dispersion, as appropriate. Between-group comparisons will be performed using suitable statistical tests according to variable type and distribution. Logistic regression models may be used to estimate the association between the intervention and study outcomes, adjusting for potential confounding variables when applicable. Results will be reported with effect estimates and 95% confidence intervals.
The study will be conducted in accordance with the Declaration of Helsinki and applicable Brazilian regulations for research involving human participants. Written informed consent will be obtained before enrollment. For participants younger than 18 years, written informed consent will be obtained from a legal guardian, and assent will be obtained from the minor participant. Participant confidentiality and data protection will be ensured in accordance with the Brazilian General Data Protection Law.
** The study has not started yet and no participants have been enrolled. The term "low-risk" was removed because the study will recruit pregnant women in general
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Enhanced microbiological screening and protocol-based treatment | Experimental | Diagnostic Test: Enhanced microbiological screeningParticipants in this arm will undergo enhanced microbiological screening as part of prenatal care. Vaginal samples will be collected at each scheduled prenatal visit for Gram stain-based assessment, and endocervical samples will be collected once per trimester for real-time PCR detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis. Vaginal and cervical infections identified during follow-up will be managed according to the predefined study protocol. Participants will be followed from first-trimester enrollment until delivery. |
| Standard prenatal care according to municipal protocol | Active comparator | Other: Standard prenatal carePregnant women in this arm will receive standard prenatal care according to the current municipal clinical protocol. Screening for Chlamydia trachomatis and Neisseria gonorrhoeae will be performed only during the first trimester and only for pregnant women younger than 30 years. Management of vulvovaginal infections will be based on clinical criteria, and treatment will follow the standard municipal protocol. Participants will be followed at quarterly intervals for data collection until delivery. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- First-trimester pregnant women.
- Receiving care at the Women's Health service.
- Willingness to participate in the study.
Key exclusion criteria (2 listed)
- #No specific exclusion criteria.
- The study has not started yet and no participants have been enrolled. The term "low-risk" was removed because the study will recruit pregnant women in general
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 |
|---|---|---|
| Enhanced microbiological screeningParticipants assigned to this intervention will undergo enhanced microbiological screening during prenatal care. Vaginal samples will be collected at all each scheduled prenatal visit for Gram stain-based evaluation, and endocervical samples will be collected once per trimester for real-time PCR detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis. Samples positive for Mycoplasma genitalium will undergo additional analysis for 23S rRNA gene mutations associated with macrolide resistance. | Diagnostic test | Experimental: Enhanced microbiological screening and protocol-based treatment |
| Standard prenatal careParticipants assigned to this intervention will receive standard prenatal care according to the current municipal clinical protocol. Screening for Chlamydia trachomatis and Neisseria gonorrhoeae will be performed only during the first trimester and only for pregnant women younger than 30 years. Management of vulvovaginal infections will be based on clinical criteria, and treatment will follow the standard municipal protocol. Participants will be followed at quarterly intervals for data collection until delivery. | Other | Standard prenatal care according to municipal protocol |
Primary outcome
Preterm birth
Time frame: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until 37 completed weeks of gestation, whichever occurs first.
Occurrence of preterm birth, defined as delivery before 37 completed weeks of gestation.
Preterm premature rupture of membranes (PPROM)
Time frame: Occurrence of preterm premature rupture of membranes before 37 completed weeks of gestation.
From randomization until delivery, assessed up to approximately 22 weeks after randomization or until 37 completed weeks of gestation, whichever occurs first.
6 secondary outcomes
Miscarriage
Time frame: Occurrence of pregnancy loss before fetal viability, defined as spontaneous pregnancy loss before 22 completed weeks of gestation, according to local clinical criteria.
Intra-amniotic infection
Time frame: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Puerperal infection
Time frame: From delivery until maternal hospital discharge, assessed up to 7 days postpartum.
Neonatal infection
Time frame: From birth until neonatal hospital discharge, assessed up to 28 days of life.
Fetal death
Time frame: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Neonatal mortality
Time frame: From birth until neonatal hospital discharge, assessed up to 28 days of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background20. ISSVD - International Society for the Study of Vulvovaginal Disease. Recommendations for the diagnosis and treatment of vaginitis. Journal of Lower Genital Tract Disease, v. 26, n. 1, p. 1-15, 2022.
- Background: PubMed 10684911Carey JC, Klebanoff MA, Hauth JC, Hillier SL, Thom EA, Ernest JM, Heine RP, Nugent RP, Fischer ML, Leveno KJ, Wapner R, Varner M. Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units. N Engl J Med. 2000 Feb 24;342(8):534-40. doi: 10.1056/NEJM200002243420802.
- Background: PubMed 39833700Sethi N, Narayanan V, Saaid R, Ahmad Adlan AS, Ngoi ST, Teh CSJ, Hamidi M; WHOW research group. Prevalence, risk factors, and adverse outcomes of bacterial vaginosis among pregnant women: a systematic review. BMC Pregnancy Childbirth. 2025 Jan 20;25(1):40. doi: 10.1186/s12884-025-07144-8.
- Background: PubMed 36860946Ng BK, Chuah JN, Cheah FC, Mohamed Ismail NA, Tan GC, Wong KK, Lim PS. Maternal and fetal outcomes of pregnant women with bacterial vaginosis. Front Surg. 2023 Feb 13;10:1084867. doi: 10.3389/fsurg.2023.1084867. eCollection 2023.
- Background: PubMed 19506551Kim MJ, Romero R, Gervasi MT, Kim JS, Yoo W, Lee DC, Mittal P, Erez O, Kusanovic JP, Hassan SS, Kim CJ. Widespread microbial invasion of the chorioamniotic membranes is a consequence and not a cause of intra-amniotic infection. Lab Invest. 2009 Aug;89(8):924-36. doi: 10.1038/labinvest.2009.49. Epub 2009 Jun 8.
- Background: PubMed 19538417Donders GG, Van Calsteren K, Bellen G, Reybrouck R, Van den Bosch T, Riphagen I, Van Lierde S. Predictive value for preterm birth of abnormal vaginal flora, bacterial vaginosis and aerobic vaginitis during the first trimester of pregnancy. BJOG. 2009 Sep;116(10):1315-24. doi: 10.1111/j.1471-0528.2009.02237.x. Epub 2009 Jun 17.
- Background: PubMed 32259236US Preventive Services Task Force; Owens DK, Davidson KW, Krist AH, Barry MJ, Cabana M, Caughey AB, Donahue K, Doubeni CA, Epling JW Jr, Kubik M, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Bacterial Vaginosis in Pregnant Persons to Prevent Preterm Delivery: US Preventive Services Task Force Recommendation Statement. JAMA. 2020 Apr 7;323(13):1286-1292. doi: 10.1001/jama.2020.2684.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. Requests for additional information may be evaluated by the study team according to ethical and institutional regulations.
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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.
Marcia da Silva, Dra study chair
São Paulo State University (UNESP), Botucatu Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced microbiological screening and Standard prenatal care in people with Neonatal Outcomes and Pregnancy Complications, Infectious, run by Universidade Federal do Pampa.
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 3 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita de Cássia Fossati Evaldt, Professor (+55 55984516440, ritaevaldt@unipampa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth (time frame: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until 37 completed weeks of gestation, whichever occurs first.). The study lists 2 primary outcomes in all. 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 NCT07592286, which also lists 7 linked publications.
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 17 Jun 2026.