Middle East Fertility Society Journal (2015) xxx, xxx–xxx

Middle East Fertility Society

Middle East Fertility Society Journal

www.mefsjournal.org
www.sciencedirect.com

ORIGINAL ARTICLE

Evaluation of the risk of postcesarean endometritis

with preoperative vaginal preparation with
povidone–iodine: A randomized controlled study
Ameer Ahamed Abdallah

Department of Obstetrics & Gynaecology, Minia University, Minia 61111, Egypt

Received 2 November 2014; accepted 27 March 2015

KEYWORDS Abstract Objective: To investigate the effect of preoperative vaginal preparation with povidone–
Postcesarean endometritis; iodine as a preventive intervention against postcesarean endometritis and wound infection.
Preoperative vaginal; Design: Randomized controlled study.
Povidone–iodine Setting: Suzan Mubarak University Hospital, Egypt & Aramco Hospital, Saudia Arabia.
Patients: 400 women were to undergononemergent cesarean delivery. Subjects received either
standard abdominal scrub alone or abdominal scrub with an additional vaginal preparation with
povidone–iodine solution. All subjects received prophylactic antibiotic preoperatively.
Interventions: Each subject’s postoperative course was reviewed for development of febrile
morbidity (temperature > 38.0 °C), endometritis (temperature > 38.4 °C accompanied by fundal
tenderness occurring beyond the first postoperative day, in the absence of evidence of other
infection), and wound infection.
Results: Postcesarean endometritis occurred in 7.0% of subjects who received a preoperative
vaginal preparation and 14.5% of controls (P < .05). There was no measurable effect of a vaginal
scrub on the development of postoperative fever or wound infection. The adjusted odds ratio for
developing endometritis after a vaginal preparation was 0.44 (95% confidence interval (CI)
0.193–0.997). Multivariate analysis showed an increased risk of developing endometritis in associ-
ation with severe anemia (adjusted OR 4.26, 95% Cl 1.568–11.582), use of intrapartum internal
monitors (adjusted OR 2.84, 95% Cl 1.311–6.136), or history of antenatal genitourinary infection
(adjusted OR 2.9, 95% CI 1.265–6.596).
Conclusion: Preoperative vaginal scrub with povidone–iodine decreases the incidence of postce-
sarean endometritis. This intervention does not seem to decrease the overall risk of postoperative
fever or wound infection.
Ó 2015 The Author. Production and hosting by Elsevier B.V. on behalf of Middle East Fertility Society.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-
nd/4.0/).

E-mail address: ameerelsherief@yahoo.com

Peer review under responsibility of Middle East Fertility Society. 1. Introduction

Postcesarean endometritis and wound infection remain signif-

Production and hosting by Elsevier icant morbidities, despite use of strategies to prevent these

http://dx.doi.org/10.1016/j.mefs.2015.03.002
1110-5690 Ó 2015 The Author. Production and hosting by Elsevier B.V. on behalf of Middle East Fertility Society.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article in press as: Abdallah AA Evaluation of the risk of postcesarean endometritis with preoperative vaginal preparation with povidone–iodine: A
randomized controlled study, Middle East Fertil Soc J (2015), http://dx.doi.org/10.1016/j.mefs.2015.03.002
2 A.A. Abdallah
complications with respect to patient cost, prolonged hospital
stay, use of parenteral antibiotics, and patient discomfort (1).
The risk of postcesarean infectious morbidity is reported to
range from 5% to 85%. The most recognized risk factors for
developing postcesarean endometritis involve pathways that
introduce large quantities of bacteria into the uterine cavity.
These include a large number of vaginal examinations in labor,
prolonged duration of active labor, prolonged membrane rup-
ture, and failure to use antimicrobial prophylaxis (2). Other
reported risk factors include nulliparity, use of internal
monitors in labor, adolescence, the presence of intrapartum
bacterial vaginosis, and the presence of an immunocompro-
mised state such as diabetes mellitus or human immunodefi-
ciency virus infection (2–4). The pathophysiology is
theoretically an ascending polymicrobial infection of cervical
and vaginal organisms into the uterus, with hematogenous
spread through exposed edges of incised myometrium. The
bacterial species implicate in postcesarean endometritis and
wound infection includes gram-negative bacilli, aerobic and
anaerobic gram-positive cocci, and anaerobic bacilli associated
with bacterial vaginosis (5–7).
There is an evidence in the literature to support the use of
preoperative vaginal scrub with povidone–iodine before a hys-
terectomy to decrease the incidence of postoperative infectious
morbidity (8). Vaginal preparation has been shown to decrease
the quantitative load of vaginal microorganisms as well as to
remove certain species of bacteria (9,10). There is limited infor-
mation in the literature regarding the ‘use of preoperative vagi-
nal preparation with povidone–iodine as a prophylactic
measure against postcesarean infectious morbidity (10). ‘‘In
this randomized controlled trial, the hypothesis that vaginal
preparation with povidone–iodine scrub before a cesarean
delivery will decrease the incidence of postoperative
endometritis, wound infection, and overall postoperative
febrile morbidity was prospectively investigated.
2. Materials and methods
Eligible patients were recruited at Suzan Mubarak University
Hospital, Egypt & Aramco Hospital, Saudia Arabia from
November 2006 through March 2010. A11 women who were
to undergo nonemergent cesarean delivery were eligible for
recruitment, excluding those with placenta previa or a diagno-
sis of chorioamnionitis. Eligible patients were approached for
the study at the time of admission for an elective cesarean
delivery or, in the case of laboring patients, at the time the
decision for cesarean delivery was made. After informed
consent was obtained, each patient was assigned to receive a
standard abdominal skin preparation with povidone–iodine
solution or the standard abdominal preparation plus an
additional 30-s vaginal scrub with povidone–iodine solution.
Vaginal preparation was performed at the time of the
abdominal scrub with povidone–iodine solution. Each sponge
was rotated 360° in the vagina such that the entire process
lasted about 30 s. All patients received a single dose of
parenteral antibiotic prophylaxis.
After the patients were discharged from the hospital and
completed a 6-week puerperal period, their charts were
reviewed for development of postoperative febrile morbidity,
diagnosis of endometritis, or diagnosis of wound infection,
Febrile morbidity was defined as any postoperative
Please cite this article in press as: Abdallah AA Evaluation of the risk of postcesarean endometritis with preoperative vaginal preparation with povidone–iodine: A
randomized controlled study, Middle East Fertil Soc J (2015), http://dx.doi.org/10.1016/j.mefs.2015.03.002
temperature greater than 38 °C. Endometritis was defined by
a temperature elevation greater than 38.4 °C persisting beyond
the first postoperative day, in association with uterine tender-
ness and foul lochia, in the absence of physical or laboratory
evidence of other infection. Wound infection was a clinical
diagnosis, evidenced by erythema or wound edge separation
with purulent drainage. This last diagnosis also included such
entities as wound dehiscence and necrotizing fasciitis, Cases of
skin separation without evidence of cellulitis were not
included, because this information was not consistently avail-
able in the hospital charts. Analysis of the number of patients
with endometritis was as a subgroup of patients with febrile
morbidity. Because febrile morbidity, endometritis, and wound
infection were defined as the primary outcomes for this study,
data were not collected with respect to other sources of postop-
erative fever such as urinary tract infection, pneumonia, atelec-
tasis, or drug fever. Appropriate antibiotic therapy was
initiated for patients with a clear diagnosis of infection,
whether pelvic or nonpelvic in origin. At our hospital, outpa-
tients who are diagnosed with postoperative wound infections
are admitted to the hospital for initial intravenous antibiotic
therapy and wound care, therefore documentation of this com-
plication is available in their hospital charts.
Other information abstracted from the chart review
included patient demographics, parity, gestational age, indica-
tion for cesarean delivery, history of antenatal genitourinary
infection, number of vaginal examinations, evidence of pro-
longed active labor (>10 h) (11) and prolonged ruptured
membranes (>18 h) (12), the presence of meconium-stained
amniotic fluid, use of internal monitors in labor, and postoper-
ative length of stay. Antenatal genitourinary infections
included urinary tract infections, bacterial vaginosis, or docu-
mented infection with Neisseria gonorrhoeae or Chlamydia
trachomatis. Additionally, hospital charts were reviewed for
the presence of maternal comorbid conditions including severe
anemia (hematocrit < 30%), diabetes, and morbid obesity
(>114 kg).
Measurement bias was minimized because the physicians
who evaluated all patients with postoperative fever were una-
ware of any patient’s participation in the study. This was pos-
sible because, at any given time, the postpartum service was a
completely different team of physicians from that which
staffed the labor and delivery unit, where patient enrollment
took place. Reporting bias was minimal, because all hospital
charts were reviewed without knowledge of patient assignment
to either arm of the study.
3. Results
Four hundred patients were recruited into the study. Thirty-
three subjects were excluded because their assignment envel-
opes that contained patient identification were lost, and no
patient information was available. Of these unidentified sub-
jects, 21 had been randomly assigned to receive a vaginal
scrub, as indicated by the envelope assignment number.
Hospital charts were unable to be located for 53 additional
patients, 28 of whom had been assigned to the treatment
group. Additionally, 6 subjects were excluded due to violation
of inclusion criteria (5 had intrapartum chorioamnionitis, and
1 patient had a vaginal delivery). In this last group, 5 patients
were assigned to receive a vaginal scrub. Ultimately, 92
Risk of postcesarean endometritis, vaginal preparation with povidone-iodine
subjects were excluded from the final analysis (Fig. 1). Primary
analysis was intention-to-treat and involved all participants
who were randomly assigned and for whom all data were
available.
Complete data were available for 308 subjects. One hun-
dred sixty-six subjects were assigned to receive a standard
abdominal scrub, and 142 subjects were assigned to receive
an additional vaginal preparation. Comparison of the control
group to the treatment group scrub did not demonstrate a sig-
nificant difference in patient demographics, pregnancy history,
obstetric characteristics, or maternal comorbid conditions
(Table 1).
Postcesarean endometritis occurred in 24 of 166 (14%) of
control patients and in 10 of 142 (7%) patients who received
a preoperative vaginal scrub (P < .05). Forty-seven of 166
(28%) control patients and 34 of 142 (24%) patients in the
treatment group developed postoperative febrile morbidity.
(P = .437) Wound infection was an infrequent complication
that developed in 2 (1.2%) control patients and l (0.7%)
patient in the treatment group. (P = .403) Postoperative
length of stay was similar in the 2 groups. A postoperative stay
that exceeded 4 days was seen in 14 (8.4%) control patients
and 7 (5.0%) of treatment patients (P = 224) (Table 2).
Multivariate analysis indicated several factors that affected
the risk for developing postcesarean endometritis. The
adjusted odds ratio (OR) for developing endometritis after a
Randomized patients
(n=400)
Identified patients
(n=367)
Identified participating patients
(n=361)
Patients available for analysis
(n=308)
Figure 1 Flow of study participants included and excluded in trial of vaginal preparation compared with abdominal scrub only.
Please cite this article in press as: Abdallah AA Evaluation of the risk of postcesarean endometritis with preoperative vaginal preparation with povidone–iodine: A
randomized controlled study, Middle East Fertil Soc J (2015), http://dx.doi.org/10.1016/j.mefs.2015.03.002
3
vaginal scrub was 0.44. (95% confidence interval [CI] 0.193–
0.997). The risk of developing endometritis was significantly
increased in association with severe anemia (adjusted OR
4.26, 95% CI 1.568–9611.582), the use of internal monitors
(adjusted OR 2.84, 95% CI 1.311–6.136), or a history of ante-
natal genitourinary infection (adjusted OR 2.89, 95% CI
1.265–6.595) (Table 3).
4. Discussion
The concept of vaginal antisepsis is not new to the field of
gynecology. Since the 1970s, it has been demonstrated that a
povidone–iodine vaginal scrub before vaginal surgery or
abdominal hysterectomy is associated with lower postopera-
tive infectious morbidity (13). Osborne and Wright (9) showed
that a preoperative povidone–iodine vaginal scrub decreased
the total number of bacterial species in the vagina by at least
98%. A preoperative vaginal scrub with povidone–iodine
was shown to remove anaerobic gram-positive bacilli and dra-
matically decreases the quantities of gram-negative bacilli and
aerobic and anaerobic gram-positive cocci, especially
Enterococcus species (14).
Risk factors for developing postcesarean endometritis have
been recognized, and all involve an increased risk of exposure
of the upper genital tract to lower tract bacteria. A large
Unidentified patients (n=33)
Vaginal preparations (n=21)
Controls (n=12)
Violations of inclusion (n=6)
Vaginal preparation (n=5)
Control (n=1)
Unavailable charts (n=53)
Vaginal preparation (n=28)
Controls (n=25)
4 A.A. Abdallah

the use of internal monitoring (15,2,5,6,11). Maternal charac-

Table 1 Baseline characteristics of study population com-
teristics that seem to contribute to the development of postce-
pared with women who received standard abdominal scrub
sarean endometritis include age and socioeconomic status,
only.
with the highest rate of infection developing in indigent young
Variable Standard Standard women (16). Additionally, the presence of bacterial vaginosis
scrub, scrub + Vaginal scrub, or other concurrent vaginal infection predisposes the patient
n = 166 n = 142 to an ascending infection. Watts et al. (4,5) found a 6-fold
Age increase of postcesarean endometritis when bacterial vaginosis
<20 years 19 (11.4) 16(11.3) was associated with delivery.
P20 years 147 (88.6) 126 (88.7) Strategies to decrease the incidence of postcesarean
Gestational age endometritis are currently being used, including conscientious
P37 weeks 136 (81.9) 126 (88.7)
surgical technique and the routine use of antibiotic prophy-
<37 weeks 30 (18.1) 16 (11.3)
Indication for Cesarean
laxis. Despite these interventions, infectious morbidity after a
Elective repeat 59 (35.5) 60 (42.2) cesarean delivery remains significant (2,3,5).
Arrested labor 35 (21.1) 39 (27.5) The effectiveness of prophylactic parenteral antibiotics has
Fetal distress 24 (14.5) l2(8.5) been well demonstrated in the literature, with cumulative data
Fetal malpresentation 28 (16.9) 14 (9.9) suggesting a reduction in postcesarean endometritis of approx-
Suspected macrosomia 4 (2.4) 3 (2.1) imately 50% in a given institution. The eradication of infection
Previous myomectomy 6 (3.6) 8 (5.6) is thus incomplete, with a resultant postcesarean endometritis
Multifetal gestation 8 (4.8) 2 (1.4) rate of 10–20% despite the use of prophylactic antibiotics
History of antenatal 30 (18.1) 23 (16.2) (3,5). Prophylaxis failure with increased doses of cefazolin
infection
has been reported, and may be due to a shift in vaginal flora
Severe anemia 98 (59.0) 79 (55.6)
(hematocrit < 30%)
with a dominance of organisms resistant to cefazolin, such as
Meconium-stained 4 (8.4) 11 (7.7) Enterococcus (2,3,6).
amniotic fluid Recent studies have investigated specific preoperative inter-
Intrapartum internal 45 (27.1) 38 (26.8) ventions to decrease the risk of postcesarean endometritis. One
monitors published study also investigated the use of preoperative vagi-
Diabetes mellitus 13 (7.8) 19 (13.4) nal preparation with povidone–iodine before cesarean delivery
Maternal obesity 44 (26.5) 25 (17.6) (10). Reid et al. (10) reported that vaginal preparation did not
(weight > 114 kg) affect the incidence of postoperative fever, endometritis, or
Number of intrapartum wound infection, however, that study did not address several
vaginal examination
potential risks for increased exposure to infection, specifically,
65 132 (79.5) 118 (83.1)
>5 32 (19.3) 24 (16.9)
a history of antenatal genitourinary infection, use of intra-
Intact membranes 53 (31.9) 56 (39.4) partum internal monitors, severe anemia, or the presence of
Prolonged rupture of 7 (4.2) 11 (7.7) diabetes mellitus or obesity. Also, that study did not indicate
membranes whether all participants received parenteral prophylactic
Prolonged active labor 16 (9.6) 14 (9.9) antibiotic at the time of umbilical cord clamping.
Pitt et al. (17) reported that the use of preoperative intrav-
aginal metronidazole gel reduced the incidence of postcesarean
endometritis, presumably by reducing the local exposure of
anaerobic bacteria during a cesarean delivery. This finding
supports our hypothesis that, similar to antisepsis before a hys-
Table 2 Postcesarean outcomes in study group compared
terectomy, postcesarean infection rates may be improved by
with control.
reducing the vaginal bacterial load preoperatively.
Outcome Standard scrub Standard + Vaginal P A general interpretation of the results suggests that a preop-
n = 166 scrub n = 142 erative vaginal scrub decreases the risk of postcesarean
Endometritis 24 (14.5) 10 (7.0) .045 endometritis. This intervention, however, does not seem to
Febrile morbidity 47 (28.3) 34 (23.9) .437
Wound infection 2 (1.2) 1 (0.7) .403
Postoperative .224
length of stay
Table 3 Multivariate analysis of factors affecting risk for
P4 d 152 (91.5) 135 (95.0)
>4 d 14 (8.4) 7 (5.0) postcesarean endometritis (N = 308).
Variable Adjusted odds 95% Confidence
ratio interval
Vaginal scrub 0.44 0.193–0.997
Severe anemia 4.26 1.568–11.582
number of vaginal examinations in labor have the strongest
(hematocrit < 30%)
association with postoperative infection, likely due to an Use of intrapartum internal 2.84 1.311–6.136
increased size and speed of entry of bacterial inoculums from monitors
the vagina into the uterus (1–12,14–16). Other frequently History of antenatal 2.89 1.265–6.595
described obstetric risk factors for postcesarean infection genitourinary infections
include pro-longed labor, prolonged membrane rupture, and

Please cite this article in press as: Abdallah AA Evaluation of the risk of postcesarean endometritis with preoperative vaginal preparation with povidone–iodine: A
randomized controlled study, Middle East Fertil Soc J (2015), http://dx.doi.org/10.1016/j.mefs.2015.03.002
Risk of postcesarean endometritis, vaginal preparation with povidone-iodine
reduce the overall risk of developing postoperative febrile mor-
bidity. Within our model, severe anemia, the use of internal
monitors, and a history of antenatal genitourinary infections
were independently associated with an increased risk of postce-
sarean endometritis. Differences in reported postoperative
endometritis rates could be attributed to the technique and
materials used for the vaginal preparation itself perhaps subtle
differences in contact time and distribution of povidone–iodine
within the vagina, or the amount of antiseptic used for the
preparation might affect infectious outcomes.
Several limitations have been identified in the assignment of
this randomized study. The total number and demographic
data of patients who underwent cesarean delivery during the
study period are unknown, therefore it is also unknown
whether we obtained a valid representation of our eligible
patient pool. There was a large amount of data that was lost
due to the unavailability of hospital charts. These data were
balanced with respect to the number of subjects assigned to
each arm of the trial. However, there was an additional large
imbalanced loss of information for the subjects excluded for
violation of recruitment criteria and for the unidentified sub-
jects for whom no data are available. In these latter 2 groups
of Patients, more information was lost for the treatment arm
of the trial. Finally, the power calculation was not met in the
final analysis of available charts. These shortcomings intro-
duce the possibility of bias, with a possible overestimation of
the treatment effect of a preoperative vaginal scrub. With
respect to the assessment of primary outcomes, we did not
collect specific data about those patients, if any, who were
diagnosed with endometritis during the first postoperative
day, nor those who may have developed fundal tenderness
and foul lochia but did not have temperatures that exceeded
38.4 °C, and the effect of vaginal preparation within this sub-
group is unknown. Additionally, an examination of nonuterine
sources of fever may be useful in interpreting the overall
incidence of febrile morbidity.
Within study population, this trial demonstrates a benefit
of a preoperative vaginal scrub just before cesarean delivery.
The incidence of postcesarean endometritis was significantly
decreased in those subjects who were scrubbed with both
abdominal and vaginal povidoneiodine compared with those
who received a standard abdominal scrub alone. Used in
conjunction with prophylactic antibiotics, a vaginal povi-
doneiodine preparation may further decrease the number of
bacteria species exposed to the endometritis at the time of uter-
ine incision, especially Enterococcus species that are resistant
to cefazolin prophylaxis. Further studies are required to con-
firm these findings before a change in practice is instituted.
Conflict of interest
The author delcares that there is no conflict of interest
statement.
Please cite this article in press as: Abdallah AA Evaluation of the risk of postcesarean endometritis with preoperative vaginal preparation with povidone–iodine: A
randomized controlled study, Middle East Fertil Soc J (2015), http://dx.doi.org/10.1016/j.mefs.2015.03.002
5
References
(1) Soper DE. Infections following cesarean section. Curr Opin
Obstet Gynecol 1993;5(5):17–20.
(2) Chang PL, Newton ER. Predictors of antibiotic prophylactic
failure in post-cesarean endometritis. Obstet Gynecol
1992;80(1):17–22.
(3) Watts DH, Hillier SL, Eschenbach. Upper genital tract isolates at
delivery as predictors of post-cesarean infections among Women
receiving antibiotic prophylaxis. Obstet Gynecol 1991;77:287–92.
(4) Gabbe SG, Niebyl JR, Simpson JL, editors. Obstetrics: normal
and problem pregnancies. London (UK): Churchill Livingstone,
Inc.; 1996.
(5) Watts DH, Krohn MA, Hillier SL, Eschenbach DA. Bacterial
vaginosis as a risk factor for post-cesarean endometritis. Obstet
Gynecol 1990;75:52–8.
(6) Roberts S, Maccato M, Faro S, Pinell P. The microbiology of
post-cesarean Wound morbidity. Obstet Gynecol 1993;81:383–6.
(7) Berenson AB, Hammill HA, Martens MG, Faro S. Bacteriologic
findings of post-cesarean endornetritis in adolescents. Obstet
Gynecol 1990;75:627–9.
(8) Eason EL, Sampalis JS, Hemmings R, Joseph L. Povidone l
iodine gel vaginal antisepsis for abdominal hysterectomy. Am J
Obstet Gynecol 1997;l76:101l–6.
(9) Osborne NG, Wright RC. Effect of preoperative scrub on the
bacterial flora of the endocervix and vagina. Obstet Gynecoll
1977;50:l48–150.
(10) Reid VC, Hartmann KE, McMahon M, Fry EP. Vaginal
preparation with povidone–iodine and postcesarean infectious
morbidity: a randomized controlled trial. Obstet Gynecol
2001;97:l47–152.
(11) Cunningham FG, Gant NF, Leveno KJ, Gilstrap LCIH, Hauth
JC, Wenstrom KD, editors. Williams’s obstetrics. New York
(NY): McGraw-Hill; 2001.
(12) Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of
prenatal Group B Streptococcal disease. Revised guidelines from
CDC. MMWR Recomrn Rep 2002;51(RR-11):l–22.
(13) Haeri AD, Kloppers LL, Forder AA, Baillie P. Effect of different
pre-operative vaginal preparations on morbidity of patients
undergoing abdominal hysterectomy. S Afr Med J
1976;50:l984–6.
(14) Amstey MS, Jones AP. Preparation of the vagina for surgery: a
comparison of povidoneiodine and saline solution. JAMA
1981;245:839–41.
(15) Gonik B, Shannon RL, Shawar R, Costner M, Seibel M. Why
patients fail antibiotic prophylaxis at cesarean delivery: histologic
evidence for incipient infection. Obstet Gynecol 1992;79:l79–84.
(16) Magann EF, Dodson MK, Ray MA, Harris RL, Martin JN,
Morrision JC. Preoperative skin preparation and intraoperative
pelvic irrigation: impact on post-cesarean endometritis and
wound infection. Obstet Gynecol 1993;81:922–5.
(17) Pitt C, Sanchez-Ramos L, Kaunitz AM. Adjunctive intravaginal
metronidazole for the prevention of postcesarean endometritis: a
randomized controlled trial. Obstet Gynecol 2001;98:745–50.