Dataset Information

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

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 .

SUBMITTER: Lee AC

PROVIDER: S-EPMC4672554 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Lee Anne C C AC Quaiyum Mohammad A MA Mullany Luke C LC Mitra Dipak K DK Labrique Alain A Ahmed Parvez P Uddin Jamal J Rafiqullah Iftekhar I DasGupta Sushil S Mahmud Arif A Koumans Emilia H EH Christian Parul P Saha Samir S Baqui Abdullah H AH

BMC pregnancy and childbirth 20151207

<h4>Background</h4>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, mater ...[more]

PMID: 26643558

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Project description:BackgroundOne-third of preterm births are attributed to pregnancy infections. We implemented a community-based intervention to screen and treat maternal genitourinary tract infections, with the aim of reducing the incidence of preterm birth.MethodsWe did an unblinded cluster-randomised controlled trial in two subdistricts of Sylhet, Bangladesh. Clusters were defined as the contiguous area served by a single community health worker, and each cluster comprised several contiguous villages, contained roughly 4000 people, and had about 120 births per year. Eligible participants within clusters were all ever-married women and girls of reproductive age (ie, aged 15-49 years) who became pregnant during the study period. Clusters were randomly assigned (1:1) to the intervention or control groups via a restricted randomisation procedure. In both groups, community health workers made home visits to identify pregnant women and girls and provide antenatal and postnatal care. Between 13 and 19 weeks' gestation, participants in the intervention group received home-based screening for abnormal vaginal flora and urinary tract infections. A random 10% of the control group also received the intervention to examine the similarity of infection prevalence between groups. If present, abnormal vaginal flora (ie, Nugent score ≥4 was treated with oral clindamycin (300 mg twice daily for 5 days) and urinary tract infections with cefixime (400 mg once daily for 3 days) or oral nitrofurantoin (100 mg twice daily for 7 days). Both infections were retreated if persistent. The primary outcome was the incidence of preterm livebirths before 37 weeks' gestation among all livebirths. This trial is registered with ClinicalTrials.gov, number NCT01572532. The trial is closed to new participants, with follow-up completed.FindingsBetween Jan 2, 2012, and July 28, 2015, 9712 pregnancies were enrolled (4840 in the intervention group, 4391 in the control group, and 481 in the control subsample). 3818 livebirths in the intervention group and 3557 livebirths in the control group were included in the primary analysis. In the intervention group, the prevalence of abnormal vaginal flora was 16·3% (95% CI 15·1-17·6) and that of urinary tract infection was 8·6% (7·7-9·5). The effective coverage of successful treatment in the intervention group was 58% in participants with abnormal vaginal flora (ie, abnormal vaginal flora resolved in 361 [58%] of the 622 participants who initially tested positive), and 71% in those with urinary tract infections (ie, resolution in 224 [71%] of the 317 participants who initially tested positive). Overall, the incidence of preterm livebirths before 37 weeks' gestation did not differ significantly between the intervention and control groups (21·8% vs 20·6%; relative risk 1·07 [95% CI 0·91-1·24]).InterpretationA population-based antenatal screening and treatment programme for genitourinary tract infections did not reduce the incidence of preterm birth in Bangladesh.FundingEunice Kennedy Shriver National Institute of Child Health and Human Development and Saving Lives at Birth Grand Challenges.

Project description:BACKGROUND:Preterm birth is a disease of multifactorial etiologies that has environmental, social, and maternal health components. Individual studies have shown that exposure to arsenic contaminated drinking water, child marriage, and low maternal weight gain during pregnancy contribute to preterm birth. These factors are highly prevalent and often co-exist in Bangladesh, a country in South Asia with one of the world's highest prevalences of preterm birth. OBJECTIVE:To evaluate the individual and interactive effects of prenatal arsenic exposure, child marriage, and pregnancy weight gain on preterm birth in a prospective birth cohort in Bangladesh. METHODS:During 2008-2011, we recruited 1613 pregnant women aged ?18years at ?16weeks of gestation and followed them until 1-month post-partum. We measured total arsenic in drinking water (n=1184) and in maternal toenails (n=1115) collected at enrollment and ?1-month post-partum, respectively using inductively coupled plasma mass spectrometry. Child marriage (<18years old) was defined using self-report, and 2nd and 3rd trimester pregnancy weight gain was calculated using monthly records. Gestational age was determined at enrollment by ultrasound. RESULTS:In multivariate adjusted Poisson regression models, the risk ratios (RR) for preterm birth were 1.12 (95% CI: 1.07-1.18) for a unit change in natural log water arsenic exposure, 2.28 (95% CI: 1.76-2.95) for child marriage, and 0.64 (95% CI: 0.42-0.97) for a pound per week increase in maternal weight during the 2nd and 3rd trimesters. In stratified analysis by child marriage, pregnancy weight gain was inversely associated with preterm birth among women with a history of child marriage (RR=0.58; 95% CI: 0.37-0.92), but not among women with no history of child marriage (RR=86; 95% CI: 0.37-2.01). Mediation analysis revealed that both arsenic exposure and child marriage had small but significant associations with preterm birth via lowering pregnancy weight gain. Similar associations were observed when arsenic exposure was assessed using maternal toenail arsenic concentrations. CONCLUSIONS:Reducing arsenic exposure and ending child marriage could reduce the risk of preterm birth in Bangladesh. Furthermore, enhancing nutritional support to ensure adequate weight gain during pregnancy may provide additional benefits especially for women with a history of child marriage.

Project description:ObjectivesLow-income and middle-income countries are undergoing epidemiological transition, however, progression is varied. Bangladesh is simultaneously experiencing continuing burden of communicable diseases and emerging burden of non-communicable diseases (NCDs). For effective use of limited resources, an increased understanding of the shifting burden and better characterisation of risk factors of NCDs, including hypertension is needed. This study provides data on prevalence and factors associated with hypertension among males and females 35 years and older in rural Bangladesh.MethodsThis is a population-based cross-sectional study conducted in Zakiganj and Kanaighat subdistricts of Sylhet district of Bangladesh. Blood pressure was measured and data on risk factors were collected using STEPS instrument from 864 males and 946 females aged 35 years and older between August 2017 and January 2018. Individuals with systolic blood pressure of ?140?mm Hg or diastolic blood pressure of ?90?mm Hg or taking antihypertensive drugs were considered hypertensive. Bivariate and multivariate analyses were performed to identify factors associated with hypertension.ResultsThe prevalence of hypertension was 18.8% (95% CI 16.3 to 21.5) and 18.7% (95% CI 16.3 to 21.3) in adult males and females, respectively. Among those who were hypertensive, the prevalence of controlled, uncontrolled and unaware/newly identified hypertension was 23.5%, 25.9% and 50.6%, respectively among males and 38.4%, 22.6% and 39.0%, respectively among females. Another 22.7% males and 17.8% females had prehypertension. Increasing age and higher waist circumference (?90?cm for males and ?80?cm for females) were positively associated with hypertension both in males (OR 4.0, 95%?CI 2.5 to 6.4) and females (OR 2.8, 95%?CI 2.0 to 4.1).ConclusionsIn view of the high burden of hypertension and prehypertension, a context-specific scalable public health programme including behaviour change communications, particularly to increase physical activity and consumption of healthy diet, as well as identification and management of hypertension needs to be developed and implemented.

Project description:ObjectiveTo improve the accuracy of the prediction of gestational age (GA) before birth with the standardised measurement of symphysis-fundal height (SFH), estimation of uterine volume, and statistical modelling including maternal anthropometrics and other factors.DesignProspective pregnancy cohort study.SettingRural communities in Sylhet, Bangladesh.Participants1516 women with singleton pregnancies with early pregnancy ultrasound dating (<20 weeks); 1486 completed follow-up.MethodsSFH and abdominal girth were measured at subsequent antenatal care (ANC) visits by community health workers at 24 to 28, 32 to 36, and/or >37 weeks gestation. An estimated uterine volume (EUV) was calculated from these measures. Data on pregnancy characteristics and other maternal anthropometrics were also collected.Primary outcome measureGA at subsequent ANC visits, as defined by early ultrasound dating.Results1486 (98%) women had at least one subsequent ANC visit, 1102 (74%) women had two subsequent ANC visits, and 748 (50%) had three visits. Using the common clinical practice of approximating the GA (in weeks) with the SFH measurement (cm), SFH systematically underestimated GA in late pregnancy (mean difference -4.4 weeks, 95% limits of agreement -12.5 to 3.7). For the classification of GA <28 weeks, SFH <26 cm had 85% sensitivity and 81% specificity; and for GA <34 weeks, SFH <29 cm had 83% sensitivity and 71% specificity. EUV had similar diagnostic accuracy. Despite rigorous statistical modelling of SFH, accounting for repeated longitudinal measurements and additional predictors, the best model without including a known last menstrual period predicted 95% of pregnancy dates within ±7.4 weeks of early ultrasound dating.ConclusionsWe were unable to predict GA with a high degree of accuracy before birth using maternal anthropometric measures and other available maternal characteristics. Efforts to improve GA dating in low- and middle-income countries before birth should focus on increasing coverage and training of ultrasonography.Trial registration numberNCT01572532.

Project description:Despite decades of attempts to link infectious agents to preterm birth, an exact causative microbe or community of microbes remains elusive. Nonculture 16S ribosomal RNA gene sequencing suggests important racial differences and pregnancy specific changes in the vaginal microbial communities. A recent study examining the association of the vaginal microbiome and preterm birth documented important findings but was performed in a predominantly white cohort. Given the important racial differences in bacterial communities within the vagina as well as persistent racial disparities in preterm birth, it is important to examine cohorts with varied demographic compositions.To characterize vaginal microbial community characteristics in a large, predominantly African-American, longitudinal cohort of pregnant women and test whether particular vaginal microbial community characteristics are associated with the risk for subsequent preterm birth.This is a nested case-control study within a prospective cohort study of women with singleton pregnancies, not on supplemental progesterone, and without cervical cerclage in situ. Serial mid-vaginal swabs were obtained by speculum exam at their routine prenatal visits. Sequencing of the V1V3 region of the 16S rRNA gene was performed on the Roche 454 platform. Alpha diversity community characteristics including richness, Shannon diversity, and evenness as well as beta diversity metrics including Bray Curtis Dissimilarity and specific taxon abundance were compared longitudinally in women who delivered preterm to those who delivered at term.A total of 77 subjects contributed 149 vaginal swabs longitudinally across pregnancy. Participants were predominantly African-American (69%) and had a preterm birth rate of 31%. In subjects with subsequent term delivery, the vaginal microbiome demonstrated stable community richness and Shannon diversity, whereas subjects with subsequent preterm delivery had significantly decreased vaginal richness, diversity, and evenness during pregnancy (P < .01). This change occurred between the first and second trimesters. Within-subject comparisons across pregnancy showed that preterm birth is associated with increased vaginal microbiome instability compared to term birth. No distinct taxa were associated with preterm birth.In a predominantly African-American population, a significant decrease of vaginal microbial community richness and diversity is associated with preterm birth. The timing of this suppression appears early in pregnancy, between the first and second trimesters, suggesting that early gestation may be an ecologically important time for events that ordain subsequent term and preterm birth outcomes.

Project description:BackgroundShort birth intervals are associated with increased risk of adverse maternal and neonatal health (MNH) outcomes. Improving postpartum contraceptive use is an important programmatic strategy to improve the health and well-being of women, newborns, and children. This article documents the intervention package and evaluation design of a study conducted in a rural district of Bangladesh to evaluate the effects of an integrated, community-based MNH and postpartum family planning program on contraceptive use and birth-interval lengths.InterventionThe study integrated family planning counseling within 5 community health worker (CHW)-household visits to pregnant and postpartum women, while a community mobilizer (CM) led community meetings on the importance of postpartum family planning and pregnancy spacing for maternal and child health. The CM and the CHWs emphasized 3 messages: (1) Use of the Lactational Amenorrhea Method (LAM) during the first 6 months postpartum and transition to another modern contraceptive method; (2) Exclusive, rather than fully or nearly fully, breastfeeding to support LAM effectiveness and good infant breastfeeding practices; (3) Use of a modern contraceptive method after a live birth for at least 24 months before attempting another pregnancy (a birth-to-birth interval of about 3 years) to support improved infant health and nutrition. CHWs provided only family planning counseling in the original study design, but we later added community-based distribution of methods, and referrals for clinical methods, to meet women's demand.MethodsUsing a quasi-experimental design, and relying primarily on pre/post-household surveys, we selected pregnant women from 4 unions to receive the intervention (n = 2,280) and pregnant women from 4 other unions (n = 2,290) to serve as the comparison group. Enrollment occurred between 2007 and 2009, and data collection ended in January 2013.Preliminary resultsFormative research showed that women and their family members generally did not perceive birth spacing as a priority, and most recently delivered women were not using contraception. At baseline, women in the intervention and comparison groups were similar in terms of age, husband's education, religion, and parity. CHWs visited over 90% of women in both intervention and comparison groups during pregnancy and the first 3 months postpartum.DiscussionThis article provides helpful intervention-design details for program managers intending to add postpartum family planning services to community-based MNH programs. Outcomes of the intervention will be reported in a future paper. Preliminary findings indicate that the package of 5 CHW visits was feasible and did not compromise worker performance. Adding doorstep delivery of contraceptives to the intervention package may enhance impact.

Dataset Information

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

Background

Methods/design

Implications/discussion

Trial registration

Publications

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

Similar Datasets

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