Evidence map›Paper›PMID 39289685›Full record

ArticleTrials2024

Synbiotics in patients at risk for spontaneous preterm birth: protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI).

Katrien Nulens, Els Papy, Katrien Tartaglia, Isabelle Dehaene, Hilde Logghe, Joachim Van Keirsbilck, Frédéric Chantraine, Veronique Masson, Eva Simoens, Willem Gysemans and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05966649 (Synbiotics in Patients at RIsk fOr Preterm Birth), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT05966649 narecruitingnot on this map

Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal

TypeinterventionalSponsorZiekenhuis Oost-LimburgRan2023 to 2029Enrolled402ConditionsPreterm Spontaneous Labor With Preterm Delivery, Preterm Birth, Microbial Colonization, Microbiome DysbiosisArmsSynbiotics, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
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

19 authors.

Katrien NulensDepartment of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium. katrien_nulens@hotmail.com.ORCID http://orcid.org/0000-0002-6718-1454
Els PapyDepartment of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium.
Katrien TartagliaClinical Trial Unit, Ziekenhuis Oost-Limburg, Genk, Belgium.
Isabelle DehaeneDepartment of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium.
Hilde LoggheDepartment of Obstetrics and Gynaecology, AZ Sint-Lucas, Bruges, Belgium.
Joachim Van KeirsbilckDepartment of Obstetrics and Gynaecology, AZ Sint-Jan, Bruges, Belgium.
Frédéric ChantraineDepartment of Obstetrics and Gynaecology, Hopital Citadelle, CHU Liège, Liège, Belgium.
Veronique MassonDepartment of Obstetrics and Gynaecology, Hopital Citadelle, CHU Liège, Liège, Belgium.
Eva SimoensDepartment of Obstetrics and Gynaecology, AZ Groeninge, Kortrijk, Belgium.
Willem GysemansDepartment of Paediatrics and Neonatal Intensive Care Unit, Ziekenhuis Oost-Limburg, Genk, Belgium.
Liesbeth BruckersData Science Institute, I-Biostat, Hasselt University, Diepenbeek, Belgium.
Sarah LebeerDepartment of Bioscience Engineering, Research Group Applied Microbiology and Biotechnology, University of Antwerp, Antwerp, Belgium.
Camille Nina AllonsiusDepartment of Bioscience Engineering, Research Group Applied Microbiology and Biotechnology, University of Antwerp, Antwerp, Belgium.
Eline OerlemansDepartment of Bioscience Engineering, Research Group Applied Microbiology and Biotechnology, University of Antwerp, Antwerp, Belgium.
Deborah SteenselsDepartment of Microbiology, Ziekenhuis Oost-Limburg, Genk, Belgium.
Marijke ReyndersDepartment of Microbiology, AZ Sint-Jan, Bruges, Belgium.
Dirk TimmermanDepartment of Development and Regeneration, KULeuven, Cluster Woman and Child, Leuven, Belgium.
Roland DevliegerDepartment of Development and Regeneration, KULeuven, Cluster Woman and Child, Leuven, Belgium.
Caroline Van HolsbekeDepartment of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrematurity remains one of the main causes of neonatal morbidity and mortality. Approximately two thirds of preterm births are spontaneous, i.e. secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) or cervical insufficiency. Etiologically, the vaginal microbiome plays an important role in spontaneous preterm birth (sPTB). Vaginal dysbiosis and bacterial vaginosis are well-known risk factors for ascending lower genital tract infections and sPTB, while a Lactobacillus crispatus-dominated vaginal microbiome is associated with term deliveries. Synbiotics may help to achieve and/or maintain a normal, Lactobacillus-dominated vaginal microbiome.

methodsWe will perform a multi-centre, double-blind, randomised, placebo-controlled trial. Women aged 18 years or older with a singleton pregnancy are eligible for inclusion at 8 DISCUSSION: This study will evaluate the effect of oral synbiotics on the vaginal microbiome during pregnancy in a high-risk population and correlate the microbial changes with the gestational age at delivery and relevant pregnancy outcomes.

trial registrationClinicalTrials.gov, NCT05966649. Registered on April 5, 2024.

Indexed as

Multicenter Studies as TopicPremature BirthRandomized Controlled Trials as TopicSynbioticsVaginaDouble-Blind MethodFemaleGestational AgeHumansInfant, NewbornMicrobiotaPregnancyRisk FactorsTreatment OutcomeVaginosis, BacterialLactobacilliNext-generation sequencingPPROMPregnancyPrematurityPreterm birthProbioticsRandomised controlled trialSynbioticsVaginal microbiome

Identifiers

PMID39289685
PMCPMC11406859

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.