Evidence map›Paper›PMID 38985817›Full record

ArticlePLOS global public health2024

Gynecologic infection rates after ablation treatment for cervical intraepithelial neoplasia grade 2 and higher (CIN2+): Secondary analysis of a non-inferiority randomized trial.

Rachel Masch, Gabriel Conzuelo-Rodriguez, Jameson A Mitchell, Karla Alfaro, Montserrat Soler, Luis F Chavez, Suhui Wu, Jinfen Sun, Longhua Hu, Dayana Marinela-Hernandez and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in PLOS global public health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03084081 (A Randomized Controlled Trial Comparing Cure Rates of Cervical Intraepithelial Neoplasia Grade 2 and Higher), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03084081 nacompletednot on this map

A Randomized Controlled Trial Comparing Cure Rates of Cervical Intraepithelial Neoplasia Grade 2 and Higher (CIN2+) Treated With CO2-based Cryotherapy, CropPen, and Thermoablation (UH3)

TypeinterventionalSponsorThe Cleveland ClinicRan2017 to 2024Enrolled1,132ConditionsCervical Intraepithelial NeoplasiaArmsCO2 standard therapy, CryoPen, Thermocoagulator
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Rachel MaschDepartment of Obstetrics, Gynecology and Reproductive Science, The Mount Sinai Hospital, New York, New York, United States of America.ORCID https://orcid.org/0000-0002-3761-858X
Gabriel Conzuelo-RodriguezBasic Health International, Pittsburgh, Pennsylvania, United States of America.ORCID https://orcid.org/0000-0002-4464-6095
Jameson A MitchellCleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States of America.ORCID https://orcid.org/0000-0003-3256-1702
Karla AlfaroBasic Health International, Pittsburgh, Pennsylvania, United States of America.
Montserrat SolerObstetrics, Gynecology Institute, Cleveland Clinic, Cleveland, Ohio, United States of America.
Luis F ChavezBasic Health International, Pittsburgh, Pennsylvania, United States of America.
Suhui WuDepartment of Obstetrics and Gynecology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China.
Jinfen SunDepartment of Obstetrics and Gynecology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China.
Longhua HuDepartment of Obstetrics and Gynecology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China.
Dayana Marinela-HernandezHospital Primero de Mayo, Instituto Salvadoreño del Seguro Social, San Salvador, El Salvador.
Todd A AlonzoDepartment of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, California, United States of America.
Juan C FelixDepartment of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, United States of America.
Miriam L CremerBasic Health International, Pittsburgh, Pennsylvania, United States of America.

Funding

CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource SettingUH3CA189883 · NCI · CLEVELAND CLINIC LERNER COM-CWRU · PI CREMER, MIRIAM · 2016 to 2018
$2.8M
NCI NIH HHS UH3 CA189883
6 · The paper itself

Abstract

Although concerns have been raised regarding potential infection and morbidity in women undergoing ablation treatment for cervical precancer in low- and middle-income countries (LMIC), there is extremely limited data to substantiate this claim. This is a secondary analysis of a randomized non-inferiority trial (id: NCT03084081) that compares the efficacy and safety of three ablation treatments for biopsy-confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+): CO2 gas-based cryotherapy, non-gas cryotherapy, and thermal ablation (TA). Here, we present findings regarding the incidence of sexually transmitted infections (STI) and vaginitis post-treatment. Samples were collected at enrollment and again at 6 weeks post-treatment and assessed for STIs (Chlamydia trachomatis (CT), Neisseria gonorrhea (NG), and Trichomonas vaginalis (TV)) and vaginitis (Bacterial vaginosis (BV) and/or Candida albicans (Candida)). This analysis reflects 864 women with baseline and 6-week follow-up data. None of the ablative treatments put women at increased risk for STIs (CT, NG, TV) or vaginitis (BV, Candida). While most women adhered to post-treatment recommendations (97%) and no difference by treatment arm was observed, the incidence of STIs at follow-up in women that did not adhere with a given recommendation was higher compared to their adherent counterparts. The incidence of gynecologic infection did not increase with any of the ablation treatments from baseline to the six-week follow-up. Non-gas cryotherapy and TA emerge as safe alternatives to gas-based cryotherapy with respect to gynecologic infection rates.

Identifiers

PMID38985817
PMCPMC11236093

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.