Evidence map›Paper›PMID 41161737›Full record

Trial reportBMJ (Clinical research ed.)2025

Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.

Kathrine Perslev, Niels Klarskov, Thomas Bergholt, Hanna Jangö

Registry-linked trialAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2025. 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 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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

4 authors.

Kathrine PerslevDepartment of Gynaecology and Obstetrics, Herlev Hospital, 2730 Herlev, Denmark Kathrine.perslev@regionh.dk.ORCID 0000-0001-5201-8171
Niels KlarskovDepartment of Gynaecology and Obstetrics, Herlev Hospital, 2730 Herlev, Denmark.ORCID 0000-0003-1906-3135
Thomas BergholtDepartment of Gynaecology and Obstetrics, Herlev Hospital, 2730 Herlev, Denmark.ORCID 0000-0002-7284-6094
Hanna JangöDepartment of Gynaecology and Obstetrics, Herlev Hospital, 2730 Herlev, Denmark.ORCID 0000-0003-0224-1425

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect of prophylactic antibiotics on the risk of wound complications after episiotomy or second degree tear.

designSingle centre, double blind, placebo controlled randomised trial.

settingOne university hospital in the Capital Region of Denmark. Participants were enrolled between March and December 2023. All initial clinical consultations were conducted between March 2023 and January 2024, and all long term follow-up consultations were conducted between March and November 2024. This article reports only data from the first consultation.

participants442 women with episiotomies or second degree tears were consecutively recruited at delivery. Exclusion criteria included treatment allergy (or risk of cross reactivity with related antibiotics), antibiotic use within 24 hours of delivery, non-Danish speakers, caesarean section, or episiotomy extension.

interventionA computer generated program randomised participants to either three doses of amoxicillin (500 mg) with clavulanic acid (125 mg) or placebo starting within six hours post partum and repeated at eight hour intervals. Follow-up was conducted four to 14 days post partum. Physicians, the steering committee, and participants were blinded.

main outcome measuresWound complications (primary outcome) and clinically relevant wound complications (secondary outcome).

resultsThe study ended as planned, in December 2024. 433 women completed follow-up and were included in the primary analysis. No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10), with a risk difference of -7.2% (95% confidence interval (CI) -15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04). For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9%

conclusionAlthough no significant effect was seen for overall wound complications, prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications in women with episiotomies and second degree tears and should be considered in postpartum care.

trial registrationClinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162.

Indexed as

Anti-Bacterial AgentsAntibiotic ProphylaxisEpisiotomySurgical Wound DehiscenceSurgical Wound InfectionAdultAmoxicillinDenmarkDouble-Blind MethodFemaleHumansLacerationsPregnancyAmoxicillinAnti-Bacterial Agents

Identifiers

PMID41161737
PMCPMC12570273

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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.