Systematic Screening of Lower Genital Tract Infections

NCT07592286 | Not Yet Recruiting

• 1 other identifier: RCT Rita
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: The investigation of systematic screening for asymptomatic genital infections in low-risk 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 low-risk 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 low-risk 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.

Conditions

Low-risk Pregnancy; Neonatal Outcomes; Pregnancy Complications, Infectious; Premature Birth; Premature Rupture of Fetal Membranes

Keywords

screening; lower genital tract infections; low-risk pregancy

Outcome Measures

Primary Outcomes (2)

• Preterm birth

  Occurrence of preterm birth, defined as delivery 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.

• 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.

  Occurrence of preterm premature rupture of membranes before 37 completed weeks of gestation.

Secondary Outcomes (6)

• Miscarriage

  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

  From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.

• Puerperal infection

  From delivery until maternal hospital discharge, assessed up to 7 days postpartum.

• Neonatal infection

  From birth until neonatal hospital discharge, assessed up to 28 days of life.

• Fetal death

  From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.

Study Arms (2)

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.

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.

Other: Standard prenatal care

Interventions

Enhanced microbiological screening DIAGNOSTIC_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.

Experimental: Enhanced microbiological screening and protocol-based treatment

Standard prenatal care OTHER

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.

Standard prenatal care according to municipal protocol

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First-trimester pregnant women.
• Low-risk pregnancy, defined as absence of comorbidities associated with medically indicated preterm birth.
• Receiving care at the Women's Health service.
• Willingness to participate in the study.

Sponsors & Collaborators

• Universidade Federal do Pampa: lead
• Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil: collaborator

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  PMID: 10684911 BACKGROUND

• Sethi 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.

  PMID: 39833700 BACKGROUND

• Ng 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.

  PMID: 36860946 BACKGROUND

• Kim 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.

  PMID: 19506551 BACKGROUND

• Donders 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.

  PMID: 19538417 BACKGROUND

• US 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.

  PMID: 32259236 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications, Infectious; Premature Birth; Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Marcia da Silva, Dra

  São Paulo State University (UNESP), Botucatu Medical School

  STUDY CHAIR

Central Study Contacts

Rita de Cássia Fossati Evaldt, Professor

CONTACT

+55 55984516440; ritaevaldt@unipampa.edu.br

Luciana Nunes, Dra

CONTACT

+55 55991745291; luciananunes@unipampa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor of Medicine

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share