Evidence map›Paper›PMID 32102825›Full record

ArticleBMJ open2020

Impact of preconception vaginal microbiota on women's risk of spontaneous preterm birth: protocol for a prospective case-cohort study.

Erica M Lokken, Kishorchandra Mandaliya, Sujatha Srinivasan, Barbra A Richardson, John Kinuthia, Sophia Lannon, Walter Jaoko, Hudson Alumera, Arthur Kemoli, Emily Fay and 3 more

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Trichomoniasis and adverse birth outcomes: a systematic review and meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2021
    Pooled it
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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 6 institutions in 2 countries.

Erica M LokkenDepartment of Epidemiology, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-3285-4751
Kishorchandra MandaliyaPathCare Kenya, Mombasa, Kenya.
Sujatha SrinivasanVaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Barbra A RichardsonDepartment of Global Health, University of Washington, Seattle, Washington, USA.
John KinuthiaResearch and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Sophia LannonNorthwest Perinatal, Portland, Oregon, USA.
Walter JaokoMedical Microbiology, University of Nairobi, Nairobi, Kenya.
Hudson AlumeraUniversity of Nairobi School of Dental Sciences, Nairobi, Kenya.
Arthur KemoliUniversity of Nairobi School of Dental Sciences, Nairobi, Kenya.
Emily FayDepartment of Obstetrics and Gynecology, University of Washington, Seattle, Washington, USA.
G John-StewartDepartment of Epidemiology, University of Washington, Seattle, Washington, USA.
David N FredricksVaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
R Scott McClellandDepartment of Epidemiology, University of Washington, Seattle, Washington, USA mcclell@uw.edu.
University of Washington · USUniversity of Nairobi · KEEducation Northwest · USFred Hutch Cancer Center · USGoCare Health Solutions Limited · KEKenyatta National Hospital · KE

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
VENEREAL DISEASET32AI007140 · NIAID · UNIVERSITY OF WASHINGTON · PI Julia Cook Dombrowski · 1985 to 2026
$19.4M
NCCIH Supplement to NCATS/CTSA Program for KL2 Scholars - M. SoddersKL2TR002317 · NCATS · UNIVERSITY OF WASHINGTON · PI Christy Michelle McKinney · 2017 to 2026
$14.5M
NRSA Training CoreTL1TR002318 · NCATS · UNIVERSITY OF WASHINGTON · PI Megan Moore · 2017 to 2026
$8.4M
Impact of periconceptual vaginal microbiota on women's risk of preterm birthR01HD087346 · NICHD · UNIVERSITY OF WASHINGTON · PI MCCLELLAND, RAYMOND SCOTT · 2016 to 2020
$3.3M
RCT of an Implementation Science Tool to Integrate HIV testing into Family Planning Services K24HD088229 · NICHD · UNIVERSITY OF WASHINGTON · PI MCCLELLAND, RAYMOND SCOTT · 2016 to 2020
$863k
NCATS NIH HHS KL2 TR002317NCATS NIH HHS TL1 TR002318NCATS NIH HHS UL1 TR002319NIAID NIH HHS T32 AI007140NICHD NIH HHS K24 HD088229NICHD NIH HHS R01 HD087346
6 · The paper itself

Abstract

introductionBacterial vaginosis (BV) and vaginal microbiota disruption during pregnancy are associated with increased risk of spontaneous preterm birth (SPTB), but clinical trials of BV treatment during pregnancy have shown little or no benefit. An alternative hypothesis is that vaginal bacteria present around conception may lead to SPTB by compromising the protective effects of cervical mucus, colonising the endometrial surface before fetal membrane development, and causing low-level inflammation in the decidua, placenta and fetal membranes. This protocol describes a prospective case-cohort study addressing this hypothesis. METHODS AND ANALYSIS: HIV-seronegative Kenyan women with fertility intent are followed from preconception through pregnancy, delivery and early postpartum. Participants provide monthly vaginal specimens during the preconception period for vaginal microbiota assessment. Estimated date of delivery is determined by last menstrual period and first trimester obstetrical ultrasound. After delivery, a swab is collected from between the fetal membranes. Placenta and umbilical cord samples are collected for histopathology. Broad-range 16S rRNA gene PCR and deep sequencing of preconception vaginal specimens will assess species richness and diversity in women with SPTB versus term delivery. Concentrations of key bacterial species will be compared using quantitative PCR (qPCR). Taxon-directed qPCR will also be used to quantify bacteria from fetal membrane samples and evaluate the association between bacterial concentrations and histopathological evidence of inflammation in the fetal membranes, placenta and umbilical cord. ETHICS AND DISSEMINATION: This study was approved by ethics committees at Kenyatta National Hospital and the University of Washington. Results will be disseminated to clinicians at study sites and partner institutions, presented at conferences and published in peer-reviewed journals. The findings of this study could shift the paradigm for thinking about the mechanisms linking vaginal microbiota and prematurity by focusing attention on the preconception vaginal microbiota as a mediator of SPTB.

Indexed as

MicrobiotaAdolescentAdultCase-Control StudiesClinical ProtocolsFemaleFollow-Up StudiesHumansKenyaMiddle AgedPreconception InjuriesPregnancyPremature BirthProspective StudiesVaginaYoung Adultepidemiologymicrobiologyobstetrics

Identifiers

PMID32102825
PMCPMC7045118
OpenAlexW3006995732

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.