Project: Screening for Bacterial Vaginosis in Pregnant Adolescents and Women to Prevent Preterm Delivery
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Project Summary

Title and Description

Title

Screening for Bacterial Vaginosis in Pregnant Adolescents and Women to Prevent Preterm Delivery

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Description

A review of the evidence about screening for bacterial vaginosis during pregnancy to prevent preterm delivery.

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Contributor(s)

The authors gratefully acknowledge the following individuals for their contributions to this project: Tina Fan, MD, MPH, AHRQ Medical Officer; Tracy Wolff, MD, MPH, AHRQ Associate Scientific Director; Quyen Ngo-Metzger, MD, MPH, Professor at Kaiser Permanente School of Medicine; current members of the U.S. Preventive Services Task Force; expert peer reviewers Mark Klebanoff, MD, MPH; John Thorp, MD; Valerie J. King, MD, MPH; and Julie van Schalkwyk, MD; two Federal partner reviewers; and RTI International–University of North Carolina EPC staff: Carol Woodell, BSPH; B. Lynn Whitener, DrPH; Sharon Barrell, MA; and Loraine Monroe.

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Methodology

We conducted a systematic review to evaluate the benefits and harms of screening and treatment for bacterial vaginosis during pregnancy to prevent preterm delivery and the diagnostic accuracy of tests used to screen for bacterial vaginosis. We searched 3 databases from January 1, 2006, through May 29, 2019, building on the literature included in the prior 2008 evidence review for the USPSTF. Because the previous reviews on this topic for the USPSTF did not include a systematic search for KQ 2 (diagnostic test accuracy), we conducted a separate PubMed search from inception through December 31, 2005, to supplement our main search for this update. Two investigators screened each abstract and full-text article for inclusion; abstracted data; and performed quality ratings, applicability ratings, and evidence grading. Where appropriate, we performed a quantitative synthesis by fitting the bivariate model to generate a summary receiver operating characteristics curve (SROC) and a pooled summary point estimate of sensitivity and specificity.

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DOI

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Funding Source

AHRQ

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Notes

Evidence tables and study quality ratings can be accessed at this link: https://srdr.s3.amazonaws.com/uploads/02-16-2021/BV+Tables+for+SRDR.docx

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Key Questions

Does screening for bacterial vaginosis in asymptomatic pregnant adolescents and women reduce preterm delivery and related morbidity and mortality? a) Does the effect of screening vary by baseline risk (e.g., low- vs. high-risk) for preterm delivery? b) Does the effect of screening vary by race/ethnicity? c) Does the effect of screening vary by maternal age? d) Does the effect of screening vary by gestational age? e) Does the effect of screening vary by other risks for preterm delivery (e.g., coinfection with STIs, HIV status)?

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What is the diagnostic accuracy of tests used to screen for bacterial vaginosis? a) Does diagnostic accuracy vary based on whether an individual is pregnant?

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What are the harms of screening for bacterial vaginosis in asymptomatic pregnant adolescents and women?

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Does treatment of bacterial vaginosis during pregnancy reduce preterm delivery and related morbidity and mortality? a) Does the effect of treatment vary by baseline risk (e.g., low- vs. high-risk) for preterm delivery? b) Does the effect of treatment vary by race/ethnicity? c) Does the effect of treatment vary by maternal age? d) Does the effect of treatment vary by gestational age? e) Does the effect of treatment vary by other risks for preterm delivery (e.g., coinfection with STIs, HIV status)?

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What are the harms of treatment of bacterial vaginosis in pregnant adolescents and women? a) What are harms to pregnant adolescents and women? b) What are harms to the fetus or newborn?

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Associated Extraction Forms

Title	Created by	Key Questions Addressed	Form Notes
Study Data for this published project can be accessed from the SRDR Published Projects page, under the link in the Study Notes section of this project	Robyn Fortman	1, 2, 3, 4, 5

Associated Studies (each link opens a new tab)

Title	Author	Year
Evaluation of a point-of-care test, BVBlue, and clinical and laboratory criteria for diagnosis of bacterial vaginosis.	Bradshaw CS., Morton AN., Garland SM., Horvath LB., Kuzevska I., Fairley CK.	2005
Evaluation of affirm VP Microbial Identification Test for Gardnerella vaginalis and Trichomonas vaginalis.	Briselden AM., Hillier SL.	1994
Safety of metronidazole in pregnancy: a meta-analysis.	Burtin P., Taddio A., Ariburnu O., Einarson TR., Koren G.	1995
Affirm VPIII microbial identification test can be used to detect gardnerella vaginalis, Candida albicans and trichomonas vaginalis microbial infections in Korean women.	Byun SW., Park YJ., Hur SY.	2016
Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units.	Carey JC., Klebanoff MA., Hauth JC., Hillier SL., Thom EA., Ernest JM., Heine RP., Nugent RP., Fischer ML., Leveno KJ., Wapner R., Varner M.	2000
Is metronidazole teratogenic? A meta-analysis.	Caro-Patón T., Carvajal A., Martin de Diego I., Martin-Arias LH., Alvarez Requejo A., Rodríguez Pinilla E.	1997
Comparison of nucleic acid amplification assays with BD affirm VPIII for diagnosis of vaginitis in symptomatic women.	Cartwright CP., Lembke BD., Ramachandran K., Body BA., Nye MB., Rivers CA., Schwebke JR.	2013
A population based case-control teratologic study of oral metronidazole treatment during pregnancy.	Czeizel AE., Rockenbauer M.	1998
Pregnancy outcome after gestational exposure to metronidazole: a prospective controlled cohort study.	Diav-Citrin O., Shechtman S., Gotteiner T., Arnon J., Ornoy A.	2001
Prevalence of bacterial vaginosis and correlation of clinical to Gram stain diagnostic criteria in low risk pregnant women.	Gratacós E., Figueras F., Barranco M., Ros R., Andreu A., Alonso PL., Cararach V.	1999
Treatment of asymptomatic bacterial vaginosis to prevent pre-term delivery: a randomised trial.	Guaschino S., Ricci E., Franchi M., Frate GD., Tibaldi C., Santo DD., Ghezzi F., Benedetto C., Seta FD., Parazzini F.	2003
Evaluation of clinical methods for diagnosing bacterial vaginosis.	Gutman RE., Peipert JF., Weitzen S., Blume J.	2005
Reduced incidence of preterm delivery with metronidazole and erythromycin in women with bacterial vaginosis.	Hauth JC., Goldenberg RL., Andrews WW., DuBard MB., Copper RL.	1995
Diagnosis of bacterial vaginosis in a gynaecology clinic.	Hay PE., Taylor-Robinson D., Lamont RF.	1992
The diagnosis of bacterial vaginosis and vaginal flora changes.	Hellberg D., Nilsson S., Mårdh PA.	2001
Vaginal clindamycin in preventing preterm birth and peripartal infections in asymptomatic women with bacterial vaginosis: a randomized, controlled trial.	Kekki M., Kurki T., Pelkonen J., Kurkinen-Räty M., Cacciatore B., Paavonen J.	2001
Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery.	Kiss H., Petricevic L., Husslein P.	2004
Intravaginal clindamycin to reduce preterm birth in women with abnormal genital tract flora.	Lamont RF., Duncan SL., Mandal D., Bassett P.	2003
Predictive value of the clinical diagnosis of lower genital tract infection in women.	Landers DV., Wiesenfeld HC., Heine RP., Krohn MA., Hillier SL.	2004
Late miscarriage and preterm birth after treatment with clindamycin: a randomised consent design study according to Zelen.	Larsson PG., Fåhraeus L., Carlsson B., Jakobsson T., Forsum U.	2006
Improving Gram-stained reproducible result by further adding clue cells in diagnosing bacterial vaginosis.	Lin DP., Pan BJ., Fuh JC., Huang TH.	2002
Wet smear compared with gram stain diagnosis of bacterial vaginosis in asymptomatic pregnant women.	Mastrobattista JM., Bishop KD., Newton ER.	2000
Impact of metronidazole therapy on preterm birth in women with bacterial vaginosis flora (Gardnerella vaginalis): a randomised, placebo controlled trial.	McDonald HM., O'Loughlin JA., Vigneswaran R., Jolley PT., Harvey JA., Bof A., McDonald PJ.	1997
Bacterial vaginosis is associated with prematurity and vaginal fluid mucinase and sialidase: results of a controlled trial of topical clindamycin cream.	McGregor JA., French JI., Jones W., Milligan K., McKinney PJ., Patterson E., Parker R.	1994
Effect of metronidazole in patients with preterm birth in preceding pregnancy and bacterial vaginosis: a placebo-controlled, double-blind study.	Morales WJ., Schorr S., Albritton J.	1994
BVBlue test for diagnosis of bacterial vaginosis.	Myziuk L., Romanowski B., Johnson SC.	2003
Detection of bacterial vaginosis in wet mount, Papanicolaou stained vaginal smears and in gram stained smears.	Platz-Christensen JJ., Larsson PG., Sundström E., Wiqvist N.	1995
A wet smear criterion for bacterial vaginosis.	Schmidt H., Hansen JG.	1994
Validity of the vaginal gram stain for the diagnosis of bacterial vaginosis.	Schwebke JR., Hillier SL., Sobel JD., McGregor JA., Sweet RL.	1996
Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis.	Schwebke JR., Gaydos CA., Nyirjesy P., Paradis S., Kodsi S., Cooper CK.	2018
The amine test: a simple, rapid, inexpensive method for diagnosing bacterial vaginosis.	Sonnex C.	1995
Safety of metronidazole during pregnancy: a cohort study of risk of congenital abnormalities, preterm delivery and low birth weight in 124 women.	Sørensen HT., Larsen H., Jensen ES., Thulstrup AM., Schønheyder HC., Nielsen GL., Czeizel A.	1999
Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial.	Subtil D., Brabant G., Tilloy E., Devos P., Canis F., Fruchart A., Bissinger MC., Dugimont JC., Nolf C., Hacot C., Gautier S., Chantrel J., Jousse M., Desseauve D., Plennevaux JL., Delaeter C., Deghilage S., Personne A., Joyez E., Guinard E., Kipnis E., Faure K., Grandbastien B., Ancel PY., Goffinet F., Dessein R.	2018
Prenatal exposure to metronidazole and risk of childhood cancer: a retrospective cohort study of children younger than 5 years.	Thapa PB., Whitlock JA., Brockman Worrell KG., Gideon P., Mitchel EF., Roberson P., Pais R., Ray WA.	1998
Prophylactic administration of clindamycin 2% vaginal cream to reduce the incidence of spontaneous preterm birth in women with an increased recurrence risk: a randomised placebo-controlled double-blind trial.	Vermeulen GM., Bruinse HW.	1999
DNA hybridization test: rapid diagnostic tool for excluding bacterial vaginosis in pregnant women with symptoms suggestive of infection.	Witt A., Petricevic L., Kaufmann U., Gregor H., Kiss H.	2002
Effect of early oral clindamycin on late miscarriage and preterm delivery in asymptomatic women with abnormal vaginal flora and bacterial vaginosis: a randomised controlled trial.	Ugwumadu A., Manyonda I., Reid F., Hay P.	2003
		2016
Accuracy of clinical diagnosis of bacterial vaginosis by human immunodeficiency virus infection status.	Gallo MF., Jamieson DJ., Cu-Uvin S., Rompalo A., Klein RS., Sobel JD.	2011
Evaluation of a rapid Gram stain interpretation method for diagnosis of bacterial vaginosis.	Hilmarsdóttir I., Hauksdóttir GS., Jóhannesdóttir JD., Daníelsdóttir T., Thorsteinsdóttir H., Olafsson JH.	2006
The role of physical examination in diagnosing common causes of vaginitis: a prospective study	Singh, R. H. Zenilman, J. M. Brown, K. M. Madden, T. Gaydos, C. Ghanem, K. G.	2013
Analysis of standard methods for diagnosing vaginitis: HIV infection does not complicate the diagnosis of vaginitis.	Sha BE., Gawel SH., Hershow RC., Passaro D., Augenbraun M., Darragh TM., Stek A., Golub ET., Mph LC., Moxley MD., Weber KM., Watts DH.	2007
Diagnosis of bacterial vaginosis in the pregnant patient in an acute care setting.	Rouse AG., Gil KM., Davis K.	2009
Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.	Lowe NK., Neal JL., Ryan-Wenger NA.	2009

Creative Commons
The data contained in this project are distributed under the terms of the Creative Commons Attribution-NonCommerical license, which permits the use, dissemination, and reproduction in any medium, provided the original work is properly cited, and that the use is non-commercial and otherwise in compliance with the license. See: https://creativecommons.org/licenses/by-nc/3.0/

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Project: Screening for Bacterial Vaginosis in Pregnant Adolescents and Women to Prevent Preterm Delivery Public Report Complete

Project: Screening for Bacterial Vaginosis in Pregnant Adolescents and Women to Prevent Preterm Delivery

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Project: Screening for Bacterial Vaginosis in Pregnant Adolescents and Women to Prevent Preterm Delivery
Public Report Complete