Evidence map›Paper›PMID 38532503›Full record

Trial reportTrials2024

The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear-a double-blinded placebo controlled randomized trial.

Kathrine Perslev, Niels Klarskov, Thomas Bergholt, Hanna Jangö

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report 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 NCT05830162 (Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% 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.

NCT05830162 phase4completednot on this map

Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail

TypeinterventionalSponsorHanna JangöRan2023 to 2024Enrolled442ConditionsObstetric Trauma, Infections, Wound DehiscenceArmsPlacebo, Bioclavid (Amoxicillin and Clavulanic acid)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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

4 authors at 2 institutions in 1 country.

Kathrine PerslevDepartment of Obstetrics and Gynecology, Herlev University Hospital, Borgmester Ib Juuls Vej 1, 15, Herlev, 2730, Denmark.
Niels KlarskovDepartment of Obstetrics and Gynecology, Herlev University Hospital, Borgmester Ib Juuls Vej 1, 15, Herlev, 2730, Denmark.
Thomas BergholtDepartment of Obstetrics and Gynecology, Herlev University Hospital, Borgmester Ib Juuls Vej 1, 15, Herlev, 2730, Denmark.
Hanna JangöDepartment of Obstetrics and Gynecology, Herlev University Hospital, Borgmester Ib Juuls Vej 1, 15, Herlev, 2730, Denmark. hanna.jango@regionh.dk.ORCID http://orcid.org/0000-0003-0224-1425
University of Copenhagen · DKHerlev Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApproximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and/or infection. Previous publications suggest that intravenous antibiotics administrated during delivery reduces this risk. We do not know if oral antibiotics given after delivery can reduce the risk of wound dehiscence or infection. Our aim is to investigate whether three doses of oral antibiotics (amoxicillin 500 mg/clavulanic acid 125 mg) given after delivery can reduce the risk of wound dehiscence and infection in patients with a second-degree obstetric tear or episiotomy.

methodsWe will perform a randomized, controlled, double-blinded study including 221women in each arm with allocation 1:1 in relation to the randomization. The study is carried out at Department of Obstetrics & Gynecology, Herlev University Hospital, Copenhagen, Denmark. The women will be included after delivery if they have had a second-degree tear or episiotomy. After inclusion, the women will have a clinical follow-up visit after 1 week. The tear and healing will be evaluated regarding signs of infection and/or dehiscence. The women will again be invited for a 1-year clinical examination including ultrasound. Questionnaires exploring symptoms related to the obstetric tear and possible complications will be answered at both visits. Our primary outcome is wound dehiscence and/or wound infection, which will be calculated using χ DISCUSSION: Reducing the risk of wound dehiscence and/or infection would decrease the number of control visits, prevent the need for longer antibiotic treatment, and possibly also decrease both short-term and long-term symptoms. This would be of great importance so the mother, her partner, and the baby could establish and optimize their initial family relation.

trial registrationThe conduction of this study is approved the 2/2-2023 with the EU-CT number: 2022-501930-49-00. CLINICALTRIALS: gov Identifier: NCT05830162.

Indexed as

Anti-Bacterial AgentsEpisiotomyAmoxicillinClavulanic AcidDelivery, ObstetricFemaleHumansPerineumPostoperative ComplicationsPregnancyRuptureAmoxicillinAnti-Bacterial AgentsClavulanic AcidAntibioticsInfectionObstetric tearRandomized controlled trialWomen’s healthWound dehiscence

Identifiers

PMID38532503
PMCPMC10967187
OpenAlexW4393233936

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.