Evidence map›Paper›PMID 30041702›Full record

ArticleTrials2018

Prophylactic antibiotics for the prevention of infection following operative vaginal delivery (ANODE): study protocol for a randomised controlled trial.

Marian Knight, Linda Mottram, Shan Gray, Christopher Partlett, Ed Juszczak, ANODE collaborative group

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Antibiotic prophylaxis for operative vaginal delivery.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Review
  4. 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

6 authors at 1 institution in 1 country.

Marian KnightNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK. Marian.knight@npeu.ox.ac.uk.ORCID http://orcid.org/0000-0002-1984-4575
Linda MottramNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.
Shan GrayNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.
Christopher PartlettNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.
Ed JuszczakNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.
ANODE collaborative group
University of Oxford · GB

Funding

Department of Health HTA/13/96/07Department of Health RP-PG-0608-10038Health Technology Assessment Programme 13/96/07
6 · The paper itself

Abstract

backgroundSepsis is one of the most important causes of maternal death and severe morbidity worldwide. Studies conducted both in the UK and US have documented an additional risk associated with operative vaginal delivery. However, a Cochrane review, updated in 2017, identified only one small trial of prophylactic antibiotics following operative vaginal delivery, which included a total of 393 women. Given the small size of that trial, it recommended that further robust evidence is needed. Operative vaginal delivery rates vary worldwide, but typically 5-10% of women have operative vaginal births. A conservative estimated incidence of maternal infection following operative vaginal delivery is 4%, based on the one previous trial. There is, therefore, considerable scope for direct patient benefit from an effective preventive strategy. METHODS/

designThis protocol describes a multicentre, randomised, blinded, placebo-controlled trial aiming to recruit 3424 participants from over 20 hospital sites in the UK. Women who have undergone an operative vaginal delivery at 36 DISCUSSION: This randomised trial will investigate whether a prophylactic dose of antibiotic following operative vaginal delivery can reduce the incidence of infection and sepsis. If shown to be effective, this could lead to a change in recommended practice and the prevention of infection. Conversely, if there is no significant difference between the two arms, then this could contribute to a reduction in antibiotic use and improved antimicrobial stewardship.

trial registrationISRCTN11166984 . Registered on 23 September 2015.

Indexed as

Antibiotic ProphylaxisAdolescentAdultAnti-Bacterial AgentsDelivery, ObstetricDrug Administration ScheduleEndometritisFemaleHumansMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicRisk FactorsSepsisSurgical Wound InfectionTime FactorsAnti-Bacterial AgentsAntibiotic prophylaxisInfectionOperative vaginal deliveryPreventionRandomised controlled trialSepsis

Identifiers

PMID30041702
PMCPMC6056933
OpenAlexW2883243256

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.