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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2015

Open Access 01-12-2015 | Study protocol

Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial

Authors: Anne CC Lee, Mohammad A. Quaiyum, Luke C. Mullany, Dipak K. Mitra, Alain Labrique, Parvez Ahmed, Jamal Uddin, Iftekhar Rafiqullah, Sushil DasGupta, Arif Mahmud, Emilia H. Koumans, Parul Christian, Samir Saha, Abdullah H. Baqui, for the Projahnmo Study Group

Published in: BMC Pregnancy and Childbirth | Issue 1/2015

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Abstract

Background

Approximately half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings. Our primary aim is to determine the impact of early pregnancy screening and treatment of maternal genitourinary tract infections on the incidence of preterm live birth in Sylhet, Bangladesh. We will also assess the effect on other adverse pregnancy outcomes, including preterm birth (stillbirth and live birth), late miscarriage, maternal morbidity, and early onset neonatal sepsis.

Methods/Design

We are conducting a cluster randomized controlled trial that will enroll 10,000 pregnant women in Sylhet district in rural northeastern Bangladesh. Twenty-four clusters, each with ~4000 population (120 pregnant women/year) and served by a community health worker (CHW), are randomized to: 1) the control arm, which provides routine antenatal and postnatal home-based care, or 2) the intervention arm, which includes routine antenatal and postnatal home-based care plus screening and treatment of pregnant women between 13 and 19 weeks of gestation for abnormal vaginal flora (AVF) and urinary tract infection (UTI). CHWs conduct monthly pregnancy surveillance, make 2 antenatal and 4 postnatal home visits for all enrolled pregnant women and newborns, and refer mothers or newborns with symptoms of serious illness to the government sub-district hospital. In the intervention clusters, CHWs perform home-based screening of AVF and UTI. Self-collected vaginal swabs are plated on slides, which are Gram stained and Nugent scored. Women with AVF (Nugent score ≥4) are treated with oral clindamycin, rescreened and retreated, if needed, after 3 weeks. Urine culture is performed and UTI treated with nitrofurantoin. Repeat urine culture is performed after 1 week for test of cure. Gestational age is determined by maternal report of last menstrual period at study enrollment using prospectively completed study calendars, and in a subset by early (<20 week) ultrasound. CHWs prospectively collect data on all pregnancy outcomes, maternal and neonatal morbidity and mortality.

Implications/Discussion

Findings will enhance our understanding of the burden of AVF and UTI in rural Bangladesh, the impact of a maternal screening-treatment program for genitourinary tract infections on perinatal health, and help formulate public health recommendations for infection screening in pregnancy in low-resource settings.

Trial registration

The study was registered on ClinicalTrials.gov:NCT01572532 on December 15, 2011. The study was funded by NICHD: R01HD066156.
Literature
1.
Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, et al. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012;379:2162–72.CrossRefPubMed
2.
Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012;379:2151–61.CrossRefPubMed
3.
Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, et al. Global, regional, and national causes of child mortality in 2000–13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015;385:430–40.CrossRefPubMed
4.
Lawn JE, Cousens S, Zupan J. 4 million neonatal deaths: when? Where? Why? Lancet. 2005;365:891–900.CrossRefPubMed
5.
Saigal S, Doyle LW. An overview of mortality and sequelae of preterm birth from infancy to adulthood. Lancet. 2008;371:261–9.CrossRefPubMed
6.
Chang HH, Larson J, Blencowe H, Spong CY, Howson CP, Cairns-Smith S, et al. Born Too Soon preterm prevention analysis group, Preventing preterm births: analysis of trends and potential reductions with interventions in 39 countries with very high human development index. Lancet. 2012;381:223–34.CrossRefPubMedPubMedCentral
7.
Joseph KS, Brahmadathan KN, Abraham S, Joseph A. Detecting bacteriuria in a primary maternal and child health care programme. Br Med J (Clin Res Ed). 1988;296:906–7.CrossRef
8.
Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371:75–84.CrossRefPubMed
9.
Hamilton BE, Minino AM, Martin JA, Kochanek KD, Strobino DM, Guyer B. Annual summary of vital statistics: 2005. Pediatrics. 2007;119:345–60.CrossRefPubMed
10.
Martius J, Eschenbach DA. The role of bacterial vaginosis as a cause of amniotic fluid infection, chorioamnionitis and prematurity--a review. Arch Gynecol Obstet. 1990;247:1–13.CrossRefPubMed
11.
Tracy SK, Tracy MB, Dean J, Laws P, Sullivan E. Spontaneous preterm birth of liveborn infants in women at low risk in Australia over 10 years: a population-based study. BJOG. 2007;114:731–5.CrossRefPubMed
12.
Newton ER. Preterm labor, preterm premature rupture of membranes, and chorioamnionitis. Clin Perinatol. 2005;32:571–600.CrossRefPubMed
13.
Stanton C, Lawn JE, Rahman H, Wilczynska-Ketende K, Hill K. Stillbirth rates: delivering estimates in 190 countries. Lancet. 2006;367:1487–94.CrossRefPubMed
14.
Goldenberg RL, Culhane JF, Johnson DC. Maternal infection and adverse fetal and neonatal outcomes. Clin Perinatol. 2005;32:523–59.CrossRefPubMed
15.
Dammann O, Leviton A. Role of the fetus in perinatal infection and neonatal brain damage. Curr Opin Pediatr. 2000;12:99–104.CrossRefPubMed
16.
Nelson KB, Willoughby RE. Infection, inflammation and the risk of cerebral palsy. Curr Opin Neurol. 2000;13:133–9.CrossRefPubMed
17.
Knippenberg R, Lawn JE, Darmstadt GL, Begkoyian G, Fogstad H, Walelign N, et al. Systematic scaling up of neonatal care in countries. Lancet. 2005;365:1087–98.CrossRefPubMed
18.
Behrman RE, Butler AS. Preterm birth: causes, consequences, and prevention. Washington: National Academies Press; 2007.
19.
20.
21.
Hillier SL, Nugent RP, Eschenbach DA, Krohn MA, Gibbs RS, Martin DH, et al. Association between bacterial vaginosis and preterm delivery of a low-birth-weight infant. The Vaginal Infections and Prematurity Study Group. N Engl J Med. 1995;333:1737–42.CrossRefPubMed
22.
Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991;29:297–301.PubMedPubMedCentral
23.
Leitich H, Kiss H. Asymptomatic bacterial vaginosis and intermediate flora as risk factors for adverse pregnancy outcome. Best Pract Res Clin Obstet Gynaecol. 2007;2:375–90.CrossRef
24.
Ugwumadu A, Manyonda I, Reid F, Hay P. 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. Lancet. 2003;361:983–8.CrossRefPubMed
25.
Donder G. Abnormal vaginal flora in the first trimeter, but not full-blown bacterial vaginosis, is associated with preterm birth. Prenatal Neonatal Med. 1998;3:588–93.
26.
Hay PE, Lamont RF, Taylor-Robinson D, Morgan DJ, Ison C, Pearson J. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. BMJ. 1994;308:295–8.CrossRefPubMedPubMedCentral
27.
McDonald HM, O’Loughlin JA, Jolley PT, Vigneswaran R, McDonald PJ. Changes in vaginal flora during pregnancy and association with preterm birth. J Infect Dis. 1994;170:724–8.CrossRefPubMed
28.
29.
Hauth JC, Goldenberg RL, Andrews WW, DuBard MB, Copper RL. Reduced incidence of preterm delivery with metronidazole and erythromycin in women with bacterial vaginosis. N Engl J Med. 1995;333:1732–6.CrossRefPubMed
30.
Carey JC, Klebanoff MA, Hauth JC, Hillier SL, Thom EA, Ernest JM, et al. 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. N Engl J Med. 2000;342:534–40.CrossRefPubMed
31.
Lamont RF, Duncan SL, Mandal D, Basset P. Intravaginal clindamycin to reduce preterm birth in women with abnormal genital tract flora. Obstet Gynecol. 2003;101:516–22.PubMed
32.
33.
McDonald HM, Brocklehurst P, Gordon A. Antibiotics for treating bacterial vaginosis in pregnancy. Cochrane Database Syst Rev. 2007;(1)CD000262.
34.
Gebre-Selassie S. Asymptomatic bacteriuria in pregnancy: epidemiological, clinical and microbiological approach. Ethiop Med J. 1998;36:185–92.PubMed
35.
Akerele J, Abhulimen P, Okonofua F. Prevalence of asymptomatic bacteriuria among pregnant women in Benin City, Nigeria. J Obstet Gynaecol. 2001;21:141–4.CrossRefPubMed
36.
37.
Hill JB, Sheffield JS, McIntire DD, Wendel Jr GD. Acute pyelonephritis in pregnancy. Obstet Gynecol. 2005;105:18–23.CrossRefPubMed
38.
Romero R, Oyarzun E, Mazor M, Sirtori M, Hobbins JC, Bracken M. Meta-analysis of the relationship between asymptomatic bacteriuria and preterm delivery/low birth weight. Obstet Gynecol. 1989;73:576–82.PubMed
39.
Meis PJ, Goldenberg RL, Mercer B, Moawad A, Das A, McNellis D, et al. The preterm prediction study: significance of vaginal infections. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. 1995;173:1231–5.CrossRefPubMed
40.
Shah R, Mullany LC, Darmstadt GL, Talukder RR, Rahman SM, Mannan I, et al. Neonatal mortality risks among preterm births in a Rural Bangladeshi Cohort. Paediatr Perinat Epidemiol. 2014;28(6):510–20.CrossRefPubMed
41.
Baqui AH, Arifeen SE, Darmstadt GL, Ahmed S, Williams EK, Seraki HR, et al. Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial. Lancet. 2008;371:1936–44.CrossRefPubMed
42.
Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, et al. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012;379:1022–8.CrossRefPubMed
43.
Christian P, Labrique AB, Richman MJ, Wu L, Rashid M, West Jr KP. Maternal vitamin A and beta-carotene supplementation and risk of bacterial vaginosis: a randomized controlled trial in rural Bangladesh. Am J Clin Nutr. 2011;94:1643–9.CrossRefPubMed
44.
Knox J, Tabrizi SN, Miller P, Petoumenos K, Law M, Chen S, et al. Evaluation of self-collected samples in contrast to practitioner-collected samples for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis by polymerase chain reaction among women living in remote areas. Sex Transm Dis. 2002;29:647–54.CrossRefPubMed
45.
Blake DR, Maldeis N, Barnes MP, Hardick A, Quinn TC, Gaydos CA. Cost-effectiveness of screening strategies for Chlamydia trachomatis using cervical swabs, urine, and self-obtained vaginal swabs in a sexually transmitted disease clinic setting. Sex Transm Dis. 2008;35:649–55.CrossRefPubMedPubMedCentral
46.
Anemona A, Plummer M, Chilongani J, Wamoyi J, Everett D, Changalucha J, et al. The acceptability and quality of self-administered vaginal swabs among adolescents in rural Tanzania. Barcelona: The XIV International AIDS Conference; 2002. p. MoPeB3116.
47.
Ugwumadu A, Reid F, Hay P, Manyonda I. Natural history of bacterial vaginosis and intermediate flora in pregnancy and effect of oral clindamycin. Obstet Gynecol. 2004;104:114–9.CrossRefPubMed
48.
Donders GG. Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol. 2007;21:355–73.CrossRefPubMed
49.
American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 91: treatment of urinary tract infections in nonpregnant women. Obstet Gynecol. 2008;111:785–94.CrossRef
50.
Baqui AH, Choi Y, Williams EK, Arifeen SE, Mannan I, Darmstadt GL, et al. Levels, timing, and etiology of stillbirths in Sylhet district of Bangladesh. BMC Pregnancy Childbirth. 2011;11:25.CrossRefPubMedPubMedCentral
51.
Baqui AH, Arifeen SE, Williams EK, Ahmed S, Mannan I, Rahman SM, et al. Effectiveness of home-based management of newborn infections by community health workers in rural Bangladesh. Pediatr Infect Dis J. 2009;28:304–10.CrossRefPubMedPubMedCentral
52.
Gove S. Integrated management of childhood illness by outpatient health workers: technical basis and overview. The WHO Working Group on Guidelines for Integrated Management of the Sick Child. Bull World Health Organ. 1997;75 Suppl 1:7–24.PubMedPubMedCentral
53.
Villar J, Cheikh Ismail L, Victora CG, Ohuma EO, Bertino E, Altman DG, et al. International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project. Lancet. 2014;384:857–68.CrossRefPubMed
54.
Kalter HD, Gray RH, Black RE, Gultiano SA. Validation of postmortem interviews to ascertain selected causes of death in children. Int J Epidemiol. 1990;19:380–6.CrossRefPubMed
55.
Baqui AH, Black RE, Arifeen SE, Hill K, Mitra SN, al Sabir A. Causes of childhood deaths in Bangladesh: results of a nationwide verbal autopsy study. Bull World Health Organ. 1998;76:161–71.PubMedPubMedCentral
56.
Kalter HD, Hossain M, Burnham G, Khan NZ, Saha SK, Ali MA, et al. Validation of caregiver interviews to diagnose common causes of severe neonatal illness. Paediatr Perinat Epidemiol. 1999;13:99–113.CrossRefPubMed
57.
Baqui AH, Darmstadt GL, Williams EK, Kumar V, Kiran TU, Panwar D, et al. Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programmes. Bull World Health Organ. 2006;84:706–13.CrossRefPubMedPubMedCentral
58.
Freeman JV, Christian P, Khatry SK, Adhikari RK, LeClerq SC, Katz J, et al. Evaluation of neonatal verbal autopsy using physician review versus algorithm-based cause-of-death assignment in rural Nepal. Paediatr Perinat Epidemiol. 2005;19:323–31.CrossRefPubMed
59.
Manatunga AK, Hudgens MG, Chen S. Sample size estimation in cluster randomized studies with varying cluster size. Biom J. 2001;43:5–86.CrossRef
60.
Schnarr J, Smaill F. Asymptomatic bacteriuria and symptomatic urinary tract infections in pregnancy. Eur J Clin Invest. 2008;38 Suppl 2:50–7.CrossRefPubMed
61.
Leitich H, Bodner-Adler B, Brunbauer M, Kaider A, Egarter C, Husslein P. Bacterial vaginosis as a risk factor for preterm delivery: a meta-analysis. Am J Obstet Gynecol. 2003;189:139–47.CrossRefPubMed
62.
Bhutta ZA, Darmstadt GL, Hasan BS, Haws RA. Community-based interventions for improving perinatal and neonatal health outcomes in developing countries: a review of the evidence. Pediatrics. 2005;115(2 Suppl):519–617.PubMed
Metadata
Title
Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial
Authors
Anne CC Lee
Mohammad A. Quaiyum
Luke C. Mullany
Dipak K. Mitra
Alain Labrique
Parvez Ahmed
Jamal Uddin
Iftekhar Rafiqullah
Sushil DasGupta
Arif Mahmud
Emilia H. Koumans
Parul Christian
Samir Saha
Abdullah H. Baqui
for the Projahnmo Study Group
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2015
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-015-0724-8

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