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Systematic Screening of Lower Genital Tract Infections

15 juin 2026 mis à jour par: Rita de Cássia Fossati Silveira Evaldt, Universidade Federal do Pampa

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.

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Estimé)

250

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • First-trimester pregnant women.
  • Receiving care at the Women's Health service.
  • Willingness to participate in the study.

Exclusion Criteria:

#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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Dépistage
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental: Enhanced microbiological screening and protocol-based treatment
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.
Test diagnostique: 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.
Comparateur actif: Standard prenatal care according to municipal protocol
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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Preterm birth
Délai: 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.
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)
Délai: 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.
Occurrence of preterm premature rupture of membranes before 37 completed weeks of gestation.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Miscarriage
Délai: Occurrence of pregnancy loss before fetal viability, defined as spontaneous pregnancy loss before 22 completed weeks of gestation, according to local clinical criteria.
Occurrence of pregnancy loss before fetal viability, as defined by local clinical criteria, 22 weeks.
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
Délai: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Occurrence of clinically diagnosed intra-amniotic infection during pregnancy or labor.
From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Puerperal infection
Délai: From delivery until maternal hospital discharge, assessed up to 7 days postpartum.
Occurrence of puerperal infection diagnosed during postpartum hospitalization, based on clinical assessment and/or medical record documentation.
From delivery until maternal hospital discharge, assessed up to 7 days postpartum.
Neonatal infection
Délai: From birth until neonatal hospital discharge, assessed up to 28 days of life.
Occurrence of clinically diagnosed neonatal infection during the neonatal hospitalization period, based on clinical assessment and/or medical record documentation.
From birth until neonatal hospital discharge, assessed up to 28 days of life.
Fetal death
Délai: From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Occurrence of fetal death during pregnancy or at delivery.
From randomization until delivery, assessed up to approximately 22 weeks after randomization or until birth, whichever occurs first.
Neonatal mortality
Délai: From birth until neonatal hospital discharge, assessed up to 28 days of life.
Occurrence of neonatal death during the neonatal hospitalization period, based on medical record documentation.
From birth until neonatal hospital discharge, assessed up to 28 days of life.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidade Federal do Pampa

Collaborateurs

Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Les enquêteurs

  • Chaise d'étude: Marcia da Silva, Dra, São Paulo State University (UNESP), Botucatu Medical School

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 juillet 2026

Achèvement primaire (Estimé)

30 juillet 2028

Achèvement de l'étude (Estimé)

30 décembre 2028

Dates d'inscription aux études

Première soumission

18 avril 2026

Première soumission répondant aux critères de contrôle qualité

13 mai 2026

Première publication (Réel)

18 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RCT Rita

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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