Evidence map›Paper›PMID 27636701›Full record

Trial reportThe European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2016

Neither vaginal nor buccal administration of 800 μg misoprostol alters mucosal and systemic immune activation or the cervicovaginal microbiome: a pilot study.

Spyros A Kalams, Lisa M Rogers, Rita M Smith, Louise Barnett, Katie Crumbo, Shonda Sumner, Naomi Prashad, Kyle Rybczyk, Ginger Milne, Scot E Dowd and 3 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 92% 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, 1 citations in OpenAlex.

  1. Article
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 at 3 institutions in 1 country.

Spyros A Kalamsa Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Lisa M Rogersa Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Rita M Smitha Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Louise Barnetta Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Katie Crumboa Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Shonda Sumnera Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Naomi Prashada Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Kyle Rybczyka Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Ginger Milneb Division of Clinical Pharmacology, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Scot E Dowdc MR DNA (Molecular Research) , Shallowater , TX , USA.
Erica Chongd Gynuity Health Projects LLC , New York , NY , USA.
Beverly Winikoffd Gynuity Health Projects LLC , New York , NY , USA.
David M Aronoffa Division of Infectious Diseases, Department of Medicine , Vanderbilt University Medical Center , Nashville , TN , USA.
Vanderbilt University Medical Center · USGynuity Health Projects · USMassanutten Regional Library · US

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
NCATS NIH HHS UL1 TR000445
6 · The paper itself

Abstract

objectivesThe aim of the study was to assess the extent to which misoprostol alters mucosal or systemic immune responses following either buccal or vaginal administration.

methodsThis was a prospective, crossover pilot study of 15 healthy, reproductive-age women. Women first received 800 μg misoprostol either via buccal or vaginal administration and were crossed over 1 month later to receive the drug via the other route. Cervicovaginal lavage samples, cervical Cytobrush samples, cervicovaginal swabs, urine and blood were obtained immediately prior to drug administration and the following day. Parameters assessed included urine and cervicovaginal misoprostol levels, whole blood cytokine responses (by ELISA) to immune stimulation with lipopolysaccharide, peripheral blood and cervical lymphocyte phenotyping by flow cytometry, cervicovaginal antimicrobial peptide measurement by ELISA and vaginal microbial ecology assessment by 16S rRNA sequencing.

resultsNeither buccal nor vaginal misoprostol significantly altered local or systemic immune and microbiological parameters.

conclusionIn this pilot study, we did not observe significant alteration of mucosal or systemic immunology or vaginal microbial ecology 1 day after drug administration following either the buccal or vaginal route.

Indexed as

Cervix UteriVaginaAbortifacient Agents, NonsteroidalAdministration, BuccalAdministration, IntravaginalCross-Over StudiesElafinEnzyme-Linked Immunosorbent AssayFemaleHumansImmune SystemLymphocytesMicrobiotaMisoprostolPilot ProjectsUnited StatesAbortifacient Agents, NonsteroidalElafinMisoprostolPI3 protein, humanAbortionmicrobial ecologymucosal immunologyprostaglandins

Identifiers

PMID27636701
PMCPMC5589076
OpenAlexW2519235315

What OpenQuestion holds

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Registered trials

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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.