Systematic Screening of Lower Genital Tract Infections

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

Interventions

DIAGNOSTIC_TEST

Enhanced microbiological screening

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.

OTHER

Standard prenatal care

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.

Sponsors & Collaborators

• Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

  collaborator OTHER

• Universidade Federal do Pampa

  lead OTHER

Principal Investigators

• Marcia da Silva, Dra · São Paulo State University (UNESP), Botucatu Medical School

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2028-07-30

Completion

2028-12-30