Trial reportBMC pregnancy and childbirth2011
Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial.
Trial report in BMC pregnancy and childbirth, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 4 of them syntheses that pooled 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.
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.
Who cites it
42 citing papers in PubMed, 4 syntheses or guidelines pooled it, 107 citations in OpenAlex.
- Vulvovaginal yeast infections during pregnancy and perinatal outcomes: systematic review and meta-analysis.BMC women's health · 2023Pooled it
- Guideline
- Treatment of vaginal candidiasis for the prevention of preterm birth: a systematic review and meta-analysis.Systematic reviews · 2015Pooled it
- Antenatal lower genital tract infection screening and treatment programs for preventing preterm delivery.The Cochrane database of systematic reviews · 2015Pooled it
- Sertaconazole 300 mg versus clotrimazole 500 mg vaginal suppository for treating pregnant women with acute vaginal candidiasis: a double-blinded, randomized trial.BMC pregnancy and childbirth · 2024Trial
- Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077].BMC pregnancy and childbirth · 2011Trial
- Article
- Vaginal colonization and vertical transmission of Candida species: prevalence and associated factors among pregnant women and their neonates at public health facilities of Northeast Ethiopia.BMC pregnancy and childbirth · 2025Article
- Article
- Utility of Cand PCR in the Diagnosis of Vulvovaginal Candidiasis in Pregnant Women.Journal of fungi (Basel, Switzerland) · 2024Article
- Congenital Sepsis withMicroorganisms · 2024Review
- Antifungal susceptibility pattern ofFrontiers in cellular and infection microbiology · 2024Article
- Stage 2: The Vaginal Flora in Women Undergoing Fetal Spina Bifida Repair and Its Potential Association with Preterm Rupture of Membranes and Preterm Birth.Journal of clinical medicine · 2022Article
- Growing importance of urogenital candidiasis in individuals with diabetes: A narrative review.World journal of diabetes · 2022Review
- The Antibiofilm Role of Biotics Family in Vaginal Fungal Infections.Frontiers in microbiology · 2022Review
- Prevalence and Risk Factors of Vulvovaginal Candidosis during Pregnancy: A Review.Infectious diseases in obstetrics and gynecology · 2022Review
- Candida Chorioamnionitis in Mothers with Gestational Diabetes Mellitus: A Report of Two Cases.International journal of environmental research and public health · 2021Article
- The impact of the Fungus-Host-Microbiota interplay upon Candida albicans infections: current knowledge and new perspectives.FEMS microbiology reviews · 2021Review
- Vulvovaginal Candidosis (Excluding Mucocutaneous Candidosis): Guideline of the German (DGGG), Austrian (OEGGG) and Swiss (SGGG) Society of Gynecology and Obstetrics (S2k-Level, AWMF Registry Number 015/072, September 2020).Geburtshilfe und Frauenheilkunde · 2021Article
- Validation of theJournal of fungi (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth.
methodsWe used a prospective, randomized, open-label, blinded-endpoint (PROBE) study design. Pregnant women presenting at <20 weeks gestation with singleton pregnancies self-collected a vaginal swab. Those who were asymptomatic and culture positive for Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg) or usual care (screening result is not revealed, no treatment). The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth <37 weeks gestation was also assessed.
resultsOf 779 women approached, 500 (64%) participated in candidiasis screening, and 98 (19.6%) had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03.
conclusionsA large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted.
trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609001052224.
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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.