Review article

Efficacy of Antibiotic Prophylaxis for Hysteroscopy: A Meta-Analysis

of Randomized Trials
Ludovico Muzii, MD, Violante Di Donato, MD, Chiara Di Tucci, MD, Anna Di Pinto, MD,
Gianluca Cascialli, MD, Marco Monti, MD, Felice Patacchiola, MD, and
Pierluigi Benedetti Panici, MD
From the Department of Obstetrics and Gynecology (Drs. Muzii, Di Donato, Di Tucci, Di Pinto, Cascialli, Monti, and Panici), “Sapienza” University of
Rome, Rome, Italy, and Department of Obstetrics and Gynecology (Dr. Patacchiola), ’San Camillo De’ Lellis’ Hospital, Rieti, Italy.

ABSTRACT Objective: To assess the efficacy and side effects of antibiotic prophylaxis compared with placebo or no treatment in
women undergoing hysteroscopy.
Data Sources: A structured search was carried out in PubMed-Medline, Embase, and Cochrane Controlled Trials Register
databases through December 31, 2018.
Methods of Study Selection: The search included a combination of the following terms: “hysteroscopy,” “endoscopic sur-
gery,” “antibiotic prophylaxis.” The following outcomes were selected: postoperative fever, infection rate, pelvic inflamma-
tory disease (PID) and abscess occurrence, postoperative antibiotic requirement, and side effects occurrence (lower
abdominal pain, vomiting, diarrhea, anaphylactic reaction). A random-effects model was used at meta-analysis. Study qual-
ity and bias risk were assessed with the Cochrane tool.
Tabulation, Integration, and Results: Five randomized controlled trials comparing efficacy of antibiotic prophylaxis with
placebo or no treatment were included in the meta-analysis. Overall, pooled incidence of events was very low in both groups
(fever, 3.79% vs 1.8%; overall infection, .52% vs .58%; postoperative antibiotic therapy, 1.18% vs 1.32%; and lower
abdominal pain, 12.46% vs 9.31%). Moreover, the incidence of serious infections requiring further actions (PID or abscess)
appeared to be extremely low (.2% in pretreated women and none in control groups). No one trial individually or the pooled
analysis showed a statistically significant benefit of antibiotics prophylaxis over placebo for the outcome considered.
Conclusion: The use of antibiotics appears not to be beneficial to prevent infection after hysteroscopy; however, the lack of
high-quality studies makes it difficult to draw firm conclusions. Considering the very low infection rate highlighted after
hysteroscopic procedures, a difference will probably never be proven in a randomized trial. A larger population and program
data to confirm these results are therefore warranted. Journal of Minimally Invasive Gynecology (2020) 27, 29−37. © 2019
AAGL. All rights reserved.
Keywords: Antibiotic prophylaxis; Hysteroscopy; Infection prevention

Operative hysteroscopy represents the gold standard for
the treatment of intrauterine pathology. The most common
indication for hysteroscopy is diagnosis, and hysteroscopy
is the treatment of most common causes of abnormal uter-
ine bleeding, infertility, and mullerian anomalies [1,2]. The
Drs. Muzii and Di Donato contributed equally to this article.
The authors declare that they have no conflict of interest.
Corresponding author: Violante Di Donato, MD, PhD, Department of
Gynecology and Obstetrics Science and Urologic Sciences, University of
Rome “Sapienza,” V. le Regina Elena, 324, 00161 Rome, Italy.
E-mail: violante.didonato@uniroma1.it
Submitted January 26, 2019, Revised June 12, 2019, Accepted for publication
July 4, 2019.
Available at www.sciencedirect.com and www.jmig.org
microbiologic flora of the lower female genital tract pro-
vides a dynamic, complex example of microbial coloniza-
tion [3,4]; therefore, transcervical procedures may
potentially increase the risk of contamination of the uterine
cavity or pelvic inflammatory disease.
The prevalence of infections after surgical hysteroscopy
is reported to be between .18% and 1.5% [5−7]. Interna-
tional guidelines do not recommend the use of antibiotic
prophylaxis for operative hysteroscopy, and limited scien-
tific evidence supports these recommendations [8−10]. A
Cochrane review, published in 2013, was unable to draw
indications about the prevention of infections after transcer-
vical intrauterine procedures [11]. Presently, only a few
randomized controlled trials (RCTs) evaluating the effect
of antibiotics compared with placebo or no treatment in

1553-4650/$ — see front matter © 2019 AAGL. All rights reserved.

https://doi.org/10.1016/j.jmig.2019.07.006
30
patients undergoing operative hysteroscopy have been
published [11].
The purpose of our analysis was to assess the effective-
ness and safety of preventive antibiotic therapy for women
undergoing hysteroscopy comparing the use and nonuse of
antibiotic therapy. We wished to determine whether preven-
tive antibiotic therapy in women undergoing hysteroscopy
reduces the occurrence of infections, reduces the occur-
rence of elevated body temperature (temperature ≥ 38˚C),
reduces the risk of lower abdominal pain, and leads to
an increased rate of serious adverse events, such as anaphy-
lactic reaction, skin rash, or colonization with antibiotic-
resistant microorganisms.
Methods
Search Strategy
The present meta-analysis was performed in accordance
with guidelines from the Cochrane Collaboration [12] and
followed Preferred Reporting Items for Systematic Reviews
and Meta-Analyses guidelines [13]. An electronic database
search was performed using for the identification of articles
published until December 2018. PubMed, Medline, and
Embase were screened to identify RCTs that evaluated the
effect of antibiotic prophylaxis over placebo or no treatment
to prevent infectious complications after hysteroscopy,
using a combination of the following search terms:
“hysteroscopy,” “endoscopic surgery,” “antibiotic prophy-
laxis.” In an effort to identify further published, unpub-
lished, and ongoing trials, we searched trials and research
registers and scanned reference lists. The search strategy
consisted of specific vocabulary and National Library of
Medicine’s Medical Subject Headings. The search strategy
is described in detail in Appendix 1.
Only articles written in English were included. The
search was conducted independently by 3 investigators
(VDD, CDT, and ADP). Discrepancies were discussed and
resolved by a consensus.
All records identified by the search were independently
screened by all reviewers. The initial screening process was
by title and abstract followed by full-text screening. Any
discrepancies between the reviewers for inclusion or exclu-
sion of the studies were resolved by discussion and consen-
sus. The process was also recorded using the Preferred
Reporting Items for Systematic Reviews and Meta-Analy-
ses flow diagram [13].
Inclusion Criteria and Trial Selection
After the search all articles considered pertinent on the
basis of the title and abstract were retrieved. Subsequently,
3 investigators independently read the full text of the pr-
selected articles to verify the pertinence of the articles to
the systematic review on antibiotic prophylaxis before hys-
teroscopy compared with no antibiotic prophylaxis.
Journal of Minimally Invasive Gynecology. Vol 27, No 1, January 2020
Inclusion criteria were prospective RCTs of preventive
antibiotic therapy versus control (placebo or open control)
in patients undergoing hysteroscopy for the following indi-
cations: menometrorrhagia, submucous myomas, postmen-
opausal bleeding, endometrial polyps, or infertility or
mullerian anomalies. Antibiotic prophylaxis was consid-
ered the administration of antibiotic before the end of the
hysteroscopy procedure. After confirmation of pertinence,
studies were excluded if reporting partial or incomplete
data. A flow diagram of the study selection process is pre-
sented in Fig. 1.
Quality Assessment
All identified RCTs were included in the meta-analysis.
The methodologic quality of each study was assessed
according to how patients were allocated to the arms of the
study, the concealment of allocation procedures, blinding,
and data loss to attrition. The studies were then classified
qualitatively according to the guidelines published in the
Cochrane Handbook for Systematic Reviews of Interven-
tions v.5.1.0 [14] .Based on the quality assessment criteria,
each study was rated and assigned to 1 of the 3 following
quality categories: A, if all quality criteria were adequately
met, the study was deemed to have a low risk of bias; B, if
1 or more of the quality criteria was only partially met or
was unclear, the study was deemed to have a moderate risk
of bias; or C, if 1 or more of the criteria was not met or not
included, the study was deemed to have a high risk of bias.
Differences were resolved by discussion among the
authors.
Outcomes
Two groups of outcomes that are particularly concerning
for patients in this context were selected: efficacy and
adverse effects.
Efficacy
The occurrence of postoperative fever was defined as an
increase in internal body temperature >38˚C on 2 consecu-
tive postoperative days or >39˚C on any 1 postoperative
day starting from 24 hours and within 10 days after the sur-
gical procedure. The occurrence of postoperative infections
was defined as any infection confirmed by positive results
of microbiologic culture or symptoms and signs confirmed
by ultrasound. The occurrence of pelvic inflammatory dis-
ease (PID) and abscess was confirmed by ultrasound. Post-
operative antibiotic therapy incidence requirement was also
assessed.
Adverse Effects
The occurrence of the following adverse events within
2 weeks after hysteroscopic procedures was assessed:
lower abdominal pain, vomiting, diarrhea, and anaphylactic
reaction.
Muzii et al. Efficacy of Antibiotic Prophylaxis for Hysteroscopy 31

Fig. 1
Flow chart identification process for the RCTs included in the meta-analysis.

PRISMA 2009 Flow Diagram

Number of records identified through searching electronic

databases (n= 1,336*).
Idenficaon

Records after duplicates removed

(n = 1,225* )
Screening

Number of titles (and/or Number of obviously irrelevant

abstracts) screened (n= 775 titles reports excluded (n= 770 titles and
and n= 450*) n = 444* )

5 full-text records excluded being:

Full-text articles assessed for
eligibility
Eligibility

- not randomized study (n= 4)

(n = 11) - not english language (n=1)

Studies included in qualitative

1 full-text article excluded,
synthesis
no data available on patients
(n =6 )
t
Included

Studies included in quantitative

synthesis (meta-analysis)
(n =5 )

From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-
Analyses: The PRISMA Statement. PLoS Med. 2009;6: e1000097.

For more informaon, visit www.prisma-statement.org.

32 Journal of Minimally Invasive Gynecology. Vol 27, No 1, January 2020

Analysis [16,17]. As regards hysteroscopic procedures, 2 studies

assessed the effects of diagnostic hysteroscopy [16,17] and
Data were pooled using RevMan software (Review Man-
3 studies the effects of operative hysteroscopy [15,18,19].
ager version 5.3; the Cochrane Collaboration, Copenhagen,
All articles included 1 group of patients who received
Denmark). Dichotomous outcomes from each study were
antibiotic prophylaxis for hysteroscopy. All studies admin-
express as an odds ratio (OR) with a 95% confidence inter-
istered beta-lactam antibiotics [15,17−19], but only 1 study
val (CI). Heterogeneity between studies was reported with
added a second antibiotic, doxycycline, for prophylaxis
the I2 statistic (Cochrane’s Q). A random-effects model was
[16]. In 3 studies patients received antibiotic prophylaxis
used at meta-analysis if any heterogeneity was detected,
during the procedure [15,17,18], in 1 study the antibiotic
whereas a fixed-effects model was used if no heterogeneity
was administered 2 hours before the procedure 16, and in 1
was identified. A value of p <.05 was considered to be sta-
study the antibiotic was administered 30 minutes before the
tistically significant. We decided to examine publication
procedure [19].
bias with Egger’s test and funnel plots if the number of
studies was 10 or above, because these analyses are under-
Random Sequence Generation
powered otherwise.
Four studies [15,17−19] gave an account of the genera-
tion of randomization sequence, so we rated these as having
Results low risk of bias for this item.

Study Characteristics and Quality of the Evidence Allocation Concealment Procedure

Sixteen studies were preselected after the electronic
search based on article title and abstract and after manual
search of the reference list of the full articles (Fig. 1). After
reading the full text 10 studies were excluded: 5 studies
because they were concerned about another topic, 1 study
was excluded because it was not written in English, and 4
studies were excluded because they were not randomized
studies. An additional study was excluded because no data
were available on patient outcome. Therefore, 5 studies
were included at the final analysis [15−19] enrolling 2327
patients: 1106 patients received antibiotic prophylaxis and
1221 did not, of which 523 women received placebo [18]
and 698 women received no therapy [15,17,19].
Characteristics of the 5 trials are shown in Table 1.
Briefly, in 1 study the indications for the hysteroscopy was
menometrorrhagia [17], in 2 studies menorrhagia [15,19];
in 1 of these studies patients were affected by submucous
myomas and polyps [19]. In 1 study the indication for hys-
teroscopy was the presence of intrauterine lesions [18]. In 2
studies the indication for hysteroscopy was infertility
Four studies [15,17−19] documented an actual proce-
dure for allocation concealment, so we rated these as having
low risk of bias for this item.
Blinding
Most studies did not report actual procedures for blind-
ing. We assessed 2 studies [18,19] as having low risk of
bias across the 3 domains we labeled “participant blind-
ed?”, “provider blinded?”, and “outcome assessor blind-
ed?”. However, we assessed 2 studies [15,17] as having low
risk of bias across the domain “outcome assessor blinded.”
Incomplete Outcome Data
Only 1 study [16] did not report clear drop-out rates. All
other studies [15,17−19] were rated as having low risk of
bias for this domain.
Selective Reporting
Four studies [15−18] did not clearly report all outcome
measures, so we rated them at unclear risk of reporting

Table 1
Characteristics of selected studies

Author n˚ of patients Indications Antibiotic regimen Timing Blinding

(year of publications) enrolled
Bhattacharya et al.1995 116 Menorrhagia Augmentin 1.2 g i.v. at induction of anesthesia yes
Kasius et al. 2011 627 Infertility canditate to Augmentin 825 gr and d 2 hours prior procedure not
ICSI/IVF Doxycycline 200 mg
Nappi et al. 2012 1046 Intrauterine lesions Cefazolin 1g im during procedure yes
Gregoriu et al. 2012 364 Menometrorrhagia, post meo- 2 g cefoxitin i.v. or 1.5 g yes
pausal bleeding, infertility cefuroxime i.v.
Muzii et al. 2016 170 Endometrial, myomas, polyps, Cefazolin 2 g iv 30 minutes prior the yes
menhorragis procedure

n˚:numbers; ICSI: Intracytoplasmic sperm injection; IVF: in vitro fertilization; im: intramuscular; iv:intravenous.
Muzii et al. Efficacy of Antibiotic Prophylaxis for Hysteroscopy
bias. None of the studies included financial disclosures. The
risk of bias is reported in Fig. 2.
Effects of Interventions
Efficacy
Fever. Three studies with 650 patients evaluated the inci-
dence of postoperative fever [15,17,19] (Fig. 3). It was
observed that incidence of fever was not statistically differ-
ent for antibiotics versus control groups (OR, 2.17; 95% CI,
.80−5.88; p = .13).
Infections. Three studies with 2041 patients reported an
overall incidence of infections [16−18]. Definitions
reported in trials included in the meta-analysis are reported
in Table 2. Nonsignificant differences were shown for the
difference in overall odds of infections for antibiotics ver-
sus control groups (OR, 1.66; 95% CI, .43−6.50; p = .46)
(Fig. 4). However, because of the different definitions of
“infection” between studies, a subanalysis was performed.
In particular, only 1 study [16] reported the occurrence of
endometritis, and a nonsignificant difference was observed
(OR, 1.71; 95% CI, .45−6.50; p = .43). Four studies on
2211 patients evaluated the cumulative incidence of PID
and abscess [16−19]. Of these, 2 studies reported no events
in both arms, whereas only 2 studies reported 1 event in 1
arm [16,17]. No significant differences were evident for
this comparison for antibiotics versus control groups (OR,
3.56; 95% CI, .38−35.20; p = .26) (Fig. 5).
Postoperative antibiotic therapy. Four studies with 2157
patients reported the incidence of postoperative antibiotics
requirement [15−18]. Nonsignificant differences were pres-
ent for the difference in overall odds of infections for antibi-
otics versus control groups (OR, .84; 95% CI, .39−1.83;
p = .66) (Fig. 6).
Adverse Effects
Only 1 study [19] reported nausea, vomiting, diarrhea,
and anaphylactic reaction; for this reason a meta-analysis
was not performed. Nonsignificant differences were present
between groups.
Lower abdominal pain. Three studies [15,17,19] reported
the incidence of lower abdominal pain between the antibi-
otic versus control groups (Fig. 7). No statistical difference
was highlighted in overall odds of lower abdominal pain
for antibiotics versus control groups (OR, 1.84; 95% CI,
.99−3.40; p = .05).
Discussion
The present meta-analysis summarizes the highest-qual-
ity evidence available in the English language gynecology
literature on antibiotic prophylaxis. On the basis of the
33
analyzed outcomes, antibiotics therapy does not reduce the
fever rate, the overall infection rate, and in particular endo-
metritis and PID after hysteroscopy.
In 2013 a Cochrane review [11] of prophylactic antibiot-
ics for transcervical intrauterine procedures failed to iden-
tify any RCTs to either support or discourage the use of
antibiotics to prevent infection for transcervical intrauterine
procedures. However, additional studies with a greater
number of patients have been published since that meta-
analysis [18,19].
Moreover, guidelines on the use of antibiotic prophy-
laxis, published by the Society of Obstetricians and Gyne-
cologists of Canada [20], the American College of
Obstetricians and Gynecologists [21], the Surgical Infection
Prevention Project [22], and the National Institute for
Health and Care Excellence [23], considered the studies
presented here as robust enough to recommend against the
use of prophylaxis in hysteroscopic surgery. The present
meta-analysis supports the current guidelines [20,23] not
recommending antibiotic prophylaxis for routine hystero-
scopic procedures.
Overall, incidences of events were very low. After hys-
teroscopy was performed in a control group, 2% had fever,
.3% had overall infection, and 1.3% had postoperative anti-
biotic therapy. When using prophylactic antibiotics, no sta-
tistical difference was highlighted.
Interestingly, the pooled incidence of serious infections
needing further actions (PID and abscess) also appeared to
be extremely low: no cases in 1160 control subjects and 2
cases in 1051 pretreated women (i.e., between 0% and
0.2%). In the present meta-analysis only 1 study [19]
reported the incidence of collateral effects, but no differen-
ces were highlighted between groups. Moreover, the pooled
incidence of lower abdominal pain was reported in 12.4%
of patients treated with prophylactic antibiotics versus
9.3% in control subjects. Although nonsignificant, all evalu-
ated adverse effects appear to be higher in the prophylactic
antibiotics group, not supporting the use of prophylactic
antibiotics before hysteroscopy.
The present review has some limitations. First, random-
ized trials are few in number and in some cases of poor
quality. Second, the indications and techniques of hysteros-
copies within the included RCTs are heterogeneous and
probably associated with different risk (cervical inflation,
uterine perforation, bleeding, etc.). Infectious complications
risk is also likely to be different between different types
of hysteroscopies. Third, a significant heterogeneity in
definitions of “infection” and timing and delivery of
“prophylaxis” is reported between studies. Fourth, different
studies report no event for some outcomes, giving a risk of
misleading or estimations. Finally, an additional potential
limitation is the heterogeneity level, which often remains
undetected in small meta-analyses and leads to poor pooled
estimates [24]. However, in most of our meta-analysis het-
erogeneity is successfully modeled using random-effects
meta-analysis methods.
34 Journal of Minimally Invasive Gynecology. Vol 27, No 1, January 2020

Fig. 2
Risk of bias assessment. (A) Risk of bias graph. (B) Risk of bias summary.

B
Muzii et al. Efficacy of Antibiotic Prophylaxis for Hysteroscopy 35

Fig. 3
Forest plot of comparison: Effect of antibiotic therapy on fever occurrence after hysteroscopy.

Table 2
Definitions of infections used in the 5 RCTs

Author Definitions
Bhattacharya the triad of fever, pelvic pain and vaginal discharge found in 72 h after procedure
Kasius Adnexitis.
Nappi 2 or more of the following signs were found in the 5 days after the procedure:
 fever (body temperature greater than 38 C or 100.4 F at repeated measurements over a period of at least 48 hours
 low abdominal pain
 uterine, adnexal, or cervical motion tenderness;
 purulent leucorrhoea
 vaginal discharge or itchiness
 dysuria
Gregoriu Vaginal discharge 12 days after procedure; fever and abdominal pain suggestive of pelvic inflammatory disease ten days after
diagnostic hysteroscopy.
Muzii Any infection confirmed by positive results of microbiological culture or symptoms of infection confirmed by ultrasound such as
endo- metritis, pelvic inflammatory disease, pelvic abscess, and cervico vaginitis.

Fig. 4
Forest plot of comparison: Effect of antibiotic therapy on overall infection rate after hysteroscopy.

Fig. 5
Forest plot of comparison: Effect of antibiotic therapy on PID or abscess occurrence after hysteroscopy.
36
Fig. 6
Forest plot of comparison: Effect of antibiotic therapy on post-operative antibiotic therapy use after hysteroscopy.
Fig. 7
Forest plot of comparison: Effect of antibiotic therapy on lower abdominal pain occurrence after hysteroscopy.
Because of the limited number of high-quality studies, a
global assessment of the patient is mandatory, especially
when treating patients with a high risk of infection (immu-
nosuppressed; transplanted; suffering from connective tis-
sue disorders, heart disease, or mitral valve prolapse with
regurgitation; history of PID or pelvic abscess) [25−27].
Considering the possible side effects, today the use
of antibiotics with no potential benefits is therefore discour-
aged. Moreover, the unconditional use of antibiotics
could increase the risk of antibiotic-resistant bacteria,
unnecessary costs, adverse reactions, and changes in natural
flora [8].
Considering the relative paucity of high-quality evidence
on this topic, conclusions could be debatable. However,
because of the very low infection rate highlighted after hys-
teroscopy in the present meta-analysis, the number of
patients needed to be included for finding a difference is
enormous. Procedures to avoid events of very low inciden-
ces will probably never be proven, and the clinical benefit
of such procedures could also be very limited.
In conclusion, the present meta-analysis summarizes the
highest-quality evidence available in literature on antibiotic
prophylaxis. The use of antibiotics appears to be nonbenefi-
cial to prevent infection after hysteroscopy; however,
the lack of high-quality studies makes it difficult to draw
firm conclusions. Considering the very low infection rate
highlighted after hysteroscopic procedures, a difference
Journal of Minimally Invasive Gynecology. Vol 27, No 1, January 2020
will probably never be proven in a randomized trial. The
number of patients needed to be included in a potential new
prospective trial to have an 80% chance (2 sided, level of
significance .05) of detecting a decrease in the primary out-
come measure from 3.8% to 1.8% is 2130. After adjustment
for noncompliance, crossover, or losses to follow-up of
about 5% in both groups 2630 patients need to be included
in the study, 1315 in each group. Large population program
data to confirm these results are therefore warranted.
Supplementary materials
Supplementary material associated with this article can
be found in the online version at https://doi.org/10.1016/j.
jmig.2019.07.006.
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