Evidence map›Paper›PMID 38107249›Full record

ArticleAJOG global reports2023

Primary prevention with vaginal chlorhexidine before 16 weeks reduces the incidence of preterm birth: results of the Preterm Labor Prevention Using Vaginal Antiseptics study.

José Morales-Roselló, Gabriela Loscalzo, Alicia Martínez-Varea, Blanca Novillo-Del Álamo, Mar Nieto-Tous

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in AJOG global reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 32% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Fetal Heart Rate at 12 Weeks' Gestation and the Risk of Preterm Birth: A Prospective Validation Study.Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine · 2026
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

José Morales-RosellóServicio de Obstetricia, Hospital Universitario y Politécnico La Fe, Valencia, Spain (Prof. Morales-Roselló, Dr Loscalzo, Dr Martínez-Varea, Dr Novillo-Del Alamo and Dr Nieto-Tous).
Gabriela LoscalzoServicio de Obstetricia, Hospital Universitario y Politécnico La Fe, Valencia, Spain (Prof. Morales-Roselló, Dr Loscalzo, Dr Martínez-Varea, Dr Novillo-Del Alamo and Dr Nieto-Tous).
Alicia Martínez-VareaServicio de Obstetricia, Hospital Universitario y Politécnico La Fe, Valencia, Spain (Prof. Morales-Roselló, Dr Loscalzo, Dr Martínez-Varea, Dr Novillo-Del Alamo and Dr Nieto-Tous).
Blanca Novillo-Del ÁlamoServicio de Obstetricia, Hospital Universitario y Politécnico La Fe, Valencia, Spain (Prof. Morales-Roselló, Dr Loscalzo, Dr Martínez-Varea, Dr Novillo-Del Alamo and Dr Nieto-Tous).
Mar Nieto-TousServicio de Obstetricia, Hospital Universitario y Politécnico La Fe, Valencia, Spain (Prof. Morales-Roselló, Dr Loscalzo, Dr Martínez-Varea, Dr Novillo-Del Alamo and Dr Nieto-Tous).
Hospital Universitari i Politècnic La Fe · ESUniversitat de València · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreterm labor is one of the leading causes of perinatal death and is currently considered a syndrome with many causes. One of the most important causes of preterm birth is ascending infection from bacterial vaginosis. Chlorhexidine has proven to be effective against bacterial vaginosis and against bacterial biofilms without affecting gestation.

objectiveWe aimed to evaluate the effectiveness of a universal primary prevention strategy for preterm birth using intravaginal chlorhexidine applied before 16 weeks (Preterm Labor Prevention Using Vaginal Antiseptics study). STUDY

designWe performed a prospective observational study with 2 cohorts of pregnant women that were assigned either to prevention of preterm birth by means of intravaginal chlorhexidine (Cum Laude Chlorhexidine, chlorhexidine digluconate 0.2%) before 16 weeks (n=413), or to no treatment following the usual hospital protocol (n=704). Primary outcomes were the incidence of spontaneous preterm birth before 34 and 37 weeks; the incidence of preterm birth before 34 and 37 weeks, including inductions for premature rupture of membranes; and the incidence of preterm birth before 34 and 37 weeks, including any indication for termination of pregnancy. Both cohorts were compared using Mann-Whitney and Fisher tests. Finally, a multivariable analysis, including the odds ratio was performed, adjusting for clinical parameters, to evaluate the importance of the different determinants in the prediction of preterm birth.

resultsIn pregnancies treated with chlorhexidine, the incidences of spontaneous preterm birth; preterm birth, including induction for premature rupture of membranas; and preterm birth, including any indication for termination of pregnancy were at 34 and 37 weeks: 0% and 0%, 0.24% and 1.69, and 2.90% and 3.15%, respectively; whereas in nontreated pregnancies, these incidences were 9% and 11%, 12% and 23%, and 35% and 43%, respectively. According to the multivariable analysis, the incidence of preterm birth among women treated with chlorhexidine before 16 weeks was halved (Odds ratio, 0.52;

conclusionUniversal treatment with vaginal chlorhexidine before 16 weeks reduces the incidence of preterm birth, especially before 34 weeks.

Indexed as

bacterial vaginosischlorhexidinelabor onsetpremature rupture of membranaspreterm birthprimary preventionvaginal dysbiosis

Identifiers

PMID38107249
PMCPMC10724831
OpenAlexW4387675966

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.