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Cochrane Database of Systematic Reviews

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

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DOI:
https://doi.org/10.1002/14651858.CD007892.pub6Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 17 July 2018see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Pregnancy and Childbirth Group

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • David M Haas

    Correspondence to: Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, USA

    [email protected]

  • Sarah Morgan

    OB/GYN Residency, St. Vincent Women's Hospital, Indianapolis, USA

  • Karenrose Contreras

    Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, USA

  • Savannah Enders

    Indiana University School of Medicine, Indianapolis, USA

Contributions of authors

David Haas is the guarantor for the review. Drs. Haas, Morgan, and Contreras developed the original protocol, data extraction sheet, and preparation of results and final original report and previous updates. Ms. Enders was added for this update and all four authors contributed to study selection, data extraction, and preparation of results and final report for this update.

Sources of support

Internal sources

  • Indiana University School of Medicine, Indianapolis, USA.

External sources

  • No sources of support supplied

Declarations of interest

David Haas is the Principal Investigator for a randomized trial included in this review (Haas 2010). He has no financial conflicts of interest to disclose.

Sarah Morgan is also an investigator in the Haas 2010 trial. She has no financial conflicts of interest to disclose.

Trial authors for Haas 2010 were not involved in assessing trial quality or extracting data from the Haas 2010 study. This task was carried out by Karenrose Contreras and a third party (Dr Jon Hathaway, MD, PhD).

Karenrose Contreras has no financial conflicts of interest to disclose.

Savannah Enders has no financial conflicts of interest to disclose.

Acknowledgements

The authors thank Dr Jon Hathaway for his independent assessment of trial quality and data extraction for the Haas 2010 study (original version of the review) and Erika Ota for preparing the 'Summary of findings' table for the previous version of this review (Haas 2014b). At that time, Erika Ota's work was financially supported by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization.

The 'Summary of findings' table in this update was prepared by the current review team using GradePro software.

As part of the pre‐publication editorial process, this review has been commented on by three peers (an editor and two referees who are external to the editorial team) and the Group's Statistical Adviser.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

We wish to thank Dr Ida Envall of Stockholm, who brought a trial to our attention that had been missed in our search methodology after the 2014 update (Haas 2014b).

Version history

Published

Title

Stage

Authors

Version

2020 Apr 26

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

Review

David M Haas, Sarah Morgan, Karenrose Contreras, Savannah Kimball

https://doi.org/10.1002/14651858.CD007892.pub7

2018 Jul 17

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

Review

David M Haas, Sarah Morgan, Karenrose Contreras, Savannah Enders

https://doi.org/10.1002/14651858.CD007892.pub6

2014 Dec 21

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

Review

David M Haas, Sarah Morgan, Karenrose Contreras

https://doi.org/10.1002/14651858.CD007892.pub5

2014 Sep 09

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

Review

David M Haas, Sarah Morgan, Karenrose Contreras

https://doi.org/10.1002/14651858.CD007892.pub4

2013 Jan 31

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

Review

David M Haas, Sarah Morgan, Karenrose Contreras

https://doi.org/10.1002/14651858.CD007892.pub3

2010 Mar 17

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

Review

David M Haas, Sarah Morgan Al Darei, Karenrose Contreras

https://doi.org/10.1002/14651858.CD007892.pub2

2009 Jul 08

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections

Protocol

David M Haas, Sarah Al Darei, Karenrose Contreras

https://doi.org/10.1002/14651858.CD007892

Differences between protocol and review

Three of the planned subgroup analyses were unable to be performed as they were not reported in the trials.

In the 2017 update, we added an additional search of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for unpublished, planned and ongoing trial reports.

A new co‐author (Savannah Enders) has joined the review team for this update.

We have edited the list of outcomes for use in GRADE. We have edited, postpartum endometritis, postoperative wound infection and postoperative fever to include definitions as per the list of outcomes in the main methods/types of outcomes. We have also added 'Composite wound complications or endometritis' to our list of outcomes for use in GRADE.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figures and Tables -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 1 Post‐cesarean endometritis.
Figures and Tables -
Analysis 1.1

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 1 Post‐cesarean endometritis.

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 2 Postoperative fever.
Figures and Tables -
Analysis 1.2

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 2 Postoperative fever.

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 3 Postoperative wound infection.
Figures and Tables -
Analysis 1.3

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 3 Postoperative wound infection.

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 4 Composite wound complication.
Figures and Tables -
Analysis 1.4

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 4 Composite wound complication.

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 5 Composite wound complication or endometritis.
Figures and Tables -
Analysis 1.5

Comparison 1 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation), Outcome 5 Composite wound complication or endometritis.

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 1 Post‐cesarean endometritis.
Figures and Tables -
Analysis 2.1

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 1 Post‐cesarean endometritis.

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 2 Postoperative fever.
Figures and Tables -
Analysis 2.2

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 2 Postoperative fever.

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 3 Postoperative wound infection.
Figures and Tables -
Analysis 2.3

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 3 Postoperative wound infection.

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 4 Composite wound complication.
Figures and Tables -
Analysis 2.4

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 4 Composite wound complication.

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 5 Composite wound complication or endometritis.
Figures and Tables -
Analysis 2.5

Comparison 2 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor, Outcome 5 Composite wound complication or endometritis.

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 1 Post‐cesarean endometritis.
Figures and Tables -
Analysis 3.1

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 1 Post‐cesarean endometritis.

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 2 Postoperative fever.
Figures and Tables -
Analysis 3.2

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 2 Postoperative fever.

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 3 Postoperative wound infection.
Figures and Tables -
Analysis 3.3

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 3 Postoperative wound infection.

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 4 Composite wound complication.
Figures and Tables -
Analysis 3.4

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 4 Composite wound complication.

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 5 Composite wound complication or endometritis.
Figures and Tables -
Analysis 3.5

Comparison 3 Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes, Outcome 5 Composite wound complication or endometritis.

Summary of findings for the main comparison. Vaginal preparation with antiseptic solution compared to control (no preparation or saline preparation) for preventing postoperative infections

Vaginal preparation with antiseptic solution compared to control (no preparation or saline preparation) for preventing postoperative infections

Patient or population: pregnant women who were about to receive a cesarean delivery. This included women receiving elective, laboring, or urgent cesareans
Setting: multiple countries (United States‐5, Pakistan‐2, Turkey‐2, Iran‐1, Saudi Arabia‐1) mostly in academic centers or large hospitals
Intervention: vaginal preparation ‐ 9 trials using iodine solution and 2 using chlorhexidine solution
Comparison: control ‐ 9 trials with no vaginal cleansing and 2 with a saline vaginal cleansing

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with control

Risk with vaginal preparation

Post‐cesarean endometritis

Study population

Average RR 0.36
(0.20 to 0.63)

3283
(10 RCTs)

⊕⊕⊕⊝
MODERATE 1

86 per 1000

31 per 1000
(17 to 54)

Postoperative fever

Study population

RR 0.87
(0.72 to 1.05)

3109
(8 RCTs)

⊕⊕⊕⊝
MODERATE 2

125 per 1000

109 per 1000
(90 to 131)

Postoperative wound infection

Study population

RR 0.74
(0.49 to 1.11)

2839
(8 RCTs)

⊕⊕⊕⊝
MODERATE 2

36 per 1000

27 per 1000
(18 to 41)

Composite wound complication or endometritis

Study population

RR 0.46
(0.26 to 0.82)

499
(2 RCTs)

⊕⊕⊕⊝
MODERATE 1

135 per 1000

62 per 1000
(35 to 111)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Over 40% of included studies had some design limitations.

2 Wide confidence intervals in included studies.

Figures and Tables -
Summary of findings for the main comparison. Vaginal preparation with antiseptic solution compared to control (no preparation or saline preparation) for preventing postoperative infections
Comparison 1. Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Post‐cesarean endometritis Show forest plot

10

3283

Risk Ratio (M‐H, Random, 95% CI)

0.36 [0.20, 0.63]

1.1 Iodine‐based solution

8

3069

Risk Ratio (M‐H, Random, 95% CI)

0.38 [0.21, 0.69]

1.2 Chlorhexidine‐based solution

2

214

Risk Ratio (M‐H, Random, 95% CI)

0.22 [0.07, 0.75]

2 Postoperative fever Show forest plot

8

3109

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.72, 1.05]

2.1 Iodine‐based solution

7

2909

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.72, 1.06]

2.2 Chlorhexidine‐based solution

1

200

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.09, 2.56]

3 Postoperative wound infection Show forest plot

8

2839

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.49, 1.11]

3.1 Iodine‐based solution

7

2639

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.50, 1.19]

3.2 Chlorhexidine‐based solution

1

200

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.17, 1.82]

4 Composite wound complication Show forest plot

2

729

Risk Ratio (M‐H, Fixed, 95% CI)

0.63 [0.37, 1.07]

5 Composite wound complication or endometritis Show forest plot

2

499

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.26, 0.82]

Figures and Tables -
Comparison 1. Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation)
Comparison 2. Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Post‐cesarean endometritis Show forest plot

5

1846

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.32, 1.06]

1.1 Women in labor

4

960

Risk Ratio (M‐H, Random, 95% CI)

0.41 [0.19, 0.89]

1.2 Women not in labor

4

886

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.35, 2.84]

2 Postoperative fever Show forest plot

3

1402

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.57, 1.03]

2.1 Women in labor

3

741

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.43, 0.96]

2.2 Women not in labor

2

661

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.61, 1.49]

3 Postoperative wound infection Show forest plot

3

1402

Risk Ratio (M‐H, Fixed, 95% CI)

0.59 [0.32, 1.08]

3.1 Women in labor

3

741

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.23, 1.24]

3.2 Women not in labor

2

661

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.27, 1.57]

4 Composite wound complication Show forest plot

2

729

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.38, 1.09]

4.1 Women in labor

2

314

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.36, 1.61]

4.2 Women not in labor

2

415

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.25, 1.16]

5 Composite wound complication or endometritis Show forest plot

2

499

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.27, 0.85]

5.1 Women in labor

2

164

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.13, 0.87]

5.2 Women not in labor

2

335

Risk Ratio (M‐H, Fixed, 95% CI)

0.60 [0.29, 1.26]

Figures and Tables -
Comparison 2. Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of labor
Comparison 3. Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Post‐cesarean endometritis Show forest plot

4

1329

Risk Ratio (M‐H, Fixed, 95% CI)

0.41 [0.27, 0.62]

1.1 Women with ruptured membranes

3

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.24 [0.10, 0.55]

1.2 Women with intact membranes

4

1057

Risk Ratio (M‐H, Fixed, 95% CI)

0.50 [0.31, 0.82]

2 Postoperative fever Show forest plot

3

1169

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.59, 1.11]

2.1 Women with ruptured membranes

2

200

Risk Ratio (M‐H, Fixed, 95% CI)

0.62 [0.34, 1.12]

2.2 Women with intact membranes

3

969

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.61, 1.30]

3 Postoperative wound infection Show forest plot

4

1329

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.43, 1.30]

3.1 Women with ruptured membranes

3

272

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.16, 6.70]

3.2 Women with intact membranes

4

1057

Risk Ratio (M‐H, Random, 95% CI)

0.68 [0.36, 1.28]

4 Composite wound complication Show forest plot

1

300

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.28, 1.44]

4.1 Women with ruptured membranes

1

76

Risk Ratio (M‐H, Fixed, 95% CI)

0.53 [0.15, 1.89]

4.2 Women with intact membranes

1

224

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.25, 2.10]

5 Composite wound complication or endometritis Show forest plot

2

500

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.27, 0.85]

5.1 Women with ruptured membranes

2

134

Risk Ratio (M‐H, Fixed, 95% CI)

0.39 [0.13, 1.13]

5.2 Women with intact membranes

2

366

Risk Ratio (M‐H, Fixed, 95% CI)

0.52 [0.26, 1.04]

Figures and Tables -
Comparison 3. Vaginal preparation with antiseptic solution versus control (no preparation or saline preparation) ‐ stratified by presence of ruptured membranes