Prevalence of and risk factors for abnormal vaginal flora and its association with adverse pregnancy outcomes in a rural district in north-east Bangladesh.

INTRODUCTION: The role of screening and treatment for abnormal vaginal flora (AVF) on adverse pregnancy outcomes remains unclear. Using data from women who participated in a population-based cluster randomized trial who were screened and treated for AVF, we report risk factors for AVF and association of persistent AVF with adverse perinatal outcomes. MATERIAL AND METHODS: Pregnant women (n = 4221) <19 weeks of gestation provided self-administered mid-vaginal swabs; smears were Nugent-scored. AVF was treated with oral clindamycin; if AVF was present 3 weeks after treatment, persistent AVF was re-treated. We examined risk factors for AVF and the association of persistent AVF with adverse pregnancy outcomes. RESULTS: The prevalence of AVF was 16.5%: 9.8% of women had bacterial vaginosis and 6.8% had intermediate flora. Lower economic and educational status of women were associated with increased risk of AVF. One-third of women with AVF had persistent abnormal flora; these women had a higher risk of a composite measure of adverse pregnancy outcomes from 20 to <37 weeks (preterm live birth, preterm still birth, late miscarriage) (relative risk [RR] 1.33, 95% confidence interval [CI] 1.07-1.65) and of late miscarriage alone (RR 4.15, 95% CI 2.12-8.12) compared to women without AVF. CONCLUSIONS: In this study in Sylhet District, Bangladesh, rates of AVF and persistent AVF were high and persistent AVF was associated with adverse pregnancy outcomes, with an especially high associated risk for late miscarriage. Further characterization of the microbiome and relative bacterial species density associated with persistent AVF is needed.

Urinary tract infections in pregnancy in a rural population of Bangladesh: population-based prevalence, risk factors, etiology, and antibiotic resistance.

BACKGROUND: Urinary tract infection (UTI) in pregnancy, including asymptomatic bacteriuria, is associated with maternal morbidity and adverse pregnancy outcomes, including preterm birth and low birthweight. In low-middle income countries (LMICs), the capacity for screening and treatment of UTIs is limited. The objective of this study was to describe the population-based prevalence, risk factors, etiology and antimicrobial resistance patterns of UTIs in pregnancy in Bangladesh. METHODS: In a community-based cohort in Sylhet district, Bangladesh, urine specimens were collected at the household level in 4242 pregnant women (< 20 weeks gestation) for culture and antibiotic susceptibility testing. Basic descriptive analysis was performed, as well as logistic regression to calculate adjusted odds ratios (aOR) for UTI risk factors. RESULTS: The prevalence of UTI was 8.9% (4.4% symptomatic UTI, 4.5% asymptomatic bacteriuria). Risk factors for UTI in this population included maternal undernutrition (mid-upper arm circumference <23 cm: aOR= 1.29, 95% CI: 1.03-1.61), primiparity (aOR= 1.45, 95% CI: 1.15-1.84), and low paternal education (no education: aOR= 1.56, 95% CI: 1.09-2.22). The predominant uro-pathogens were E. coli (38% of isolates), Klebsiella (12%), and staphyloccocal species (23%). Group B streptococcus accounted for 5.3% of uro-pathogens. Rates of antibiotic resistance were high, with only two-thirds of E. coli susceptible to 3rd generation cephalosporins. CONCLUSIONS: In Sylhet, Bangladesh, one in 11 women had a UTI in pregnancy, and approximately half of cases were asymptomatic. There is a need for low-cost and accurate methods for UTI screening in pregnancy and efforts to address increasing rates of antibiotic resistance in LMIC.

Household coping strategies for delivery and related healthcare cost: findings from rural Bangladesh.

OBJECTIVES: This study aims to measure the economic costs of maternal complication and to understand household coping strategies for financing maternal healthcare cost. METHODS: A household survey of the 706 women with maternal complication, of whom 483 had normal delivery, was conducted to collect data at 6 weeks and 6 months post-partum. Data were collected on socio-economic information of the household, expenditure during delivery and post-partum, coping strategies adopted by households and other related information. RESULTS: Despite the high cost of health care associated with maternal complications, the majority of families were capable of protecting consumption on non-health items. Around one-third of households spent more than 20% of their annual household expenditure on maternal health care. Almost 50% were able to avoid catastrophic spending because of the coping strategies that they relied on. In general, households appeared resilient to short-term economic consequences of maternal health shocks, due to the availability of informal credit, donations from relatives and selling assets. While richer households fund a greater portion of the cost of maternal health care from income and savings, the poorer households with severe maternal complication resorted to borrowing from local moneylenders at high interest, which may leave them vulnerable to financial difficulties. CONCLUSION: Financial protection, especially for the poor, may benefit households against economic consequences of maternal complication.

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

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 .

Costs of maternal health-related complications in Bangladesh.

This paper assesses both out-of-pocket payments for healthcare and losses of productivity over six months postpartum among women who gave birth in Matlab, Bangladesh. The hypothesis of the study objective is that obstetric morbidity leads women to seek care at which time out-of-pocket expenditure is incurred. Second, a woman may also take time out from employment or from doing her household chores. This loss of resources places a financial burden on the household that may lead to reduced consumption of usual but less important goods and use of other services depending on the extent to which a household copes up by using savings, taking loans, and selling assets. Women were divided into three groups based on their morbidity patterns: (a) women with a severe obstetric complication (n=92); (b) women with a less-severe obstetric complication (n=127); and (c) women with a normal delivery (n=483). Data were collected from households of these women at two time-points--at six weeks and six months after delivery. The results showed that maternal morbidity led to a considerable loss of resources up to six weeks postpartum, with the greatest financial burden of cost of healthcare among the poorest households. However, families coped up with loss of resources by taking loans and selling assets, and by the end of six months postpartum, the households had paid back more than 40% of the loans.

Profile of maternal and foetal complications during labour and delivery among women giving birth in hospitals in Matlab and Chandpur, Bangladesh.

Worldwide, for an estimated 358,000 women, pregnancy and childbirth end in death and mourning, and beyond these maternal deaths, 9-10% of pregnant women or about 14 million women per year suffer from acute maternal complications. This paper documents the types and severity of maternal and foetal complications among women who gave birth in hospitals in Matlab and Chandpur, Bangladesh, during 2007-2008. The Community Health Research Workers (CHRWs) of the icddr,b service area in Matlab prospectively collected data for the study from 4,817 women on their places of delivery and pregnancy outcomes. Of them, 3,010 (62.5%) gave birth in different hospitals in Matlab and/or Chandpur and beyond. Review of hospital-records was attempted for 2,102 women who gave birth only in the Matlab Hospital of icddr,b and in other public and private hospitals in the Matlab and Chandpur area. Among those, 1,927 (91.7%) records were found and reviewed by a physician. By reviewing the hospital-records, 7.3% of the women (n=1,927) who gave birth in the local hospitals were diagnosed with a severe maternal complication, and 16.1% with a less-severe maternal complication. Abortion cases--either spontaneous or induced--were excluded from the analysis. Over 12% of all births were delivered by caesarean section (CS). For a substantial proportion (12.5%) of CS, no clear medical indication was recorded in the hospital-register. Twelve maternal deaths occurred during the study period; most (83%) of them had been in contact with a hospital before death. Recommendations include standardization of the hospital record-keeping system, proper monitoring of indications of CS, and introduction of maternal death audit for further improvement of the quality of care in public and private hospitals in rural Bangladesh.

Effect of parent's death on child survival in rural Bangladesh: a cohort study.

BACKGROUND: The effect of a parent's death on the survival of the children has been assessed in only a few studies. We therefore investigated the effect of the death of the mother or father on the survival of the child up to age 10 years in rural Bangladesh. METHODS: We used data from population surveillance during 1982-2005 in Matlab, Bangladesh. We used Kaplan-Meier and Poisson regression analyses to compute the cumulative probabilities of survival and rates of age-specific death up to age 10 years, according to the survival status of the mother or father during that period. FINDINGS: There were 144 861 livebirths, and 14 868 children died by 10 years of age. The cumulative probability of survival to age 10 years was 24% in children whose mothers died (n=1385) before their tenth birthday, compared with 89% in those whose mothers remained alive (n=143 473). The greatest effect was noted in children aged 2-5 months whose mothers had died (rate ratio 25.05, 95% CI 18.57-33.81). The effect of the father's death (n=2691) on cumulative probability of survival of the child up to 10 years of age was negligible. Age-specific death rates did not differ in children whose fathers died compared with children whose fathers were alive. INTERPRETATION: The devastating effects of the mother's death on the survival of the child were most probably due to the abrupt cessation of breastfeeding, but the persistence of the effects up to 10 years of age suggest that the absence of maternal care might be a crucial factor. FUNDING: US Agency for International Development, UK Department for International Development, Research Program Consortium, and National Institutes of Health Fogarty International Center.

Effect of population-based antenatal screening and treatment of genitourinary tract infections on birth outcomes in Sylhet, Bangladesh (MIST): a cluster-randomised clinical trial.

BACKGROUND: One-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. METHODS: We 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. FINDINGS: Between 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]). INTERPRETATION: A population-based antenatal screening and treatment programme for genitourinary tract infections did not reduce the incidence of preterm birth in Bangladesh. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development and Saving Lives at Birth Grand Challenges.

Development and validation of a simplified algorithm for neonatal gestational age assessment - protocol for the Alliance for Maternal Newborn Health Improvement (AMANHI) prospective cohort study.

OBJECTIVE: The objective of the Alliance for Maternal and Newborn Health Improvement (AMANHI) gestational age study is to develop and validate a programmatically feasible and simple approach to accurately assess gestational age of babies after they are born. The study will provide accurate, population-based rates of preterm birth in different settings and quantify the risks of neonatal mortality and morbidity by gestational age and birth weight in five South Asian and sub-Saharan African sites. METHODS: This study used on-going population-based cohort studies to recruit pregnant women early in pregnancy (<20 weeks) for a dating ultrasound scan. Implementation is harmonised across sites in Ghana, Tanzania, Zambia, Bangladesh and Pakistan with uniform protocols and standard operating procedures. Women whose pregnancies are confirmed to be between 8 to 19 completed weeks of gestation are enrolled into the study. These women are followed up to collect socio-demographic and morbidity data during the pregnancy. When they deliver, trained research assistants visit women within 72 hours to assess the baby for gestational maturity. They assess for neuromuscular and physical characteristics selected from the Ballard and Dubowitz maturation assessment scales. They also measure newborn anthropometry and assess feeding maturity of the babies. Computer machine learning techniques will be used to identify the most parsimonious group of signs that correctly predict gestational age compared to the early ultrasound date (the gold standard). This gestational age will be used to categorize babies into term, late preterm and early preterm groups. Further, the ultrasound-based gestational age will be used to calculate population-based rates of preterm birth. IMPORTANCE OF THE STUDY: The AMANHI gestational age study will make substantial contribution to improve identification of preterm babies by frontline health workers in low- and middle- income countries using simple evaluations. The study will provide accurate preterm birth estimates. This new information will be crucial to planning and delivery of interventions for improving preterm birth outcomes, particularly in South Asia and sub-Saharan Africa.

Validity of Newborn Clinical Assessment to Determine Gestational Age in Bangladesh.

BACKGROUND: Gestational age (GA) is frequently unknown or inaccurate in pregnancies in low-income countries. Early identification of preterm infants may help link them to potentially life-saving interventions. METHODS: We conducted a validation study in a community-based birth cohort in rural Bangladesh. GA was determined by pregnancy ultrasound (<20 weeks). Community health workers conducted home visits (<72 hours) to assess physical/neuromuscular signs and measure anthropometrics. The distribution, agreement, and diagnostic accuracy of different clinical methods of GA assessment were determined compared with early ultrasound dating. RESULTS: In the live-born cohort (n = 1066), the mean ultrasound GA was 39.1 weeks (SD 2.0) and prevalence of preterm birth (<37 weeks) was 11.4%. Among assessed newborns (n = 710), the mean ultrasound GA was 39.3 weeks (SD 1.6) (8.3% preterm) and by Ballard scoring the mean GA was 38.9 weeks (SD 1.7) (12.9% preterm). The average bias of the Ballard was -0.4 weeks; however, 95% limits of agreement were wide (-4.7 to 4.0 weeks) and the accuracy for identifying preterm infants was low (sensitivity 16%, specificity 87%). Simplified methods for GA assessment had poor diagnostic accuracy for identifying preterm births (community health worker prematurity scorecard [sensitivity/specificity: 70%/27%]; Capurro [5%/96%]; Eregie [75%/58%]; Bhagwat [18%/87%], foot length <75 mm [64%/35%]; birth weight <2500 g [54%/82%]). Neonatal anthropometrics had poor to fair performance for classifying preterm infants (areas under the receiver operating curve 0.52-0.80). CONCLUSIONS: Newborn clinical assessment of GA is challenging at the community level in low-resource settings. Anthropometrics are also inaccurate surrogate markers for GA in settings with high rates of fetal growth restriction.

Genital human papillomavirus infection among women in Bangladesh: findings from a population-based survey.

BACKGROUND: There has been no population-based study on human papillomavirus (HPV) prevalence or its genotypes in Bangladesh; a country eligible for GAVI funding for HPV vaccine. METHODS: We used baseline survey data of a prospective cohort study that was conducted in one urban and one rural area of Bangladesh. A total of 997 urban and 905 rural married women, aged 13 to 64 years, were enrolled in the baseline during July-December, 2011. Information was collected on socio-demographic characteristics and potential risk factors for HPV infection followed by gynecological examination and collection of endocervical samples using the cervical cytobrush (Digene cervical sampler). HPV DNA testing was done by Polymerase Chain Reaction (PCR) using a consensus primer set. RESULTS: Prevalence of any HPV infection was 7.7% with no significant difference between urban and rural women. Most common high-risk genotypes were HPV16, HPV66, HPV18, HPV45, HPV31 and HPV53. Urban women working as housemaids or garment workers were at higher risk of any HPV infection (OR = 2.15, 95% CI: 1.13-4.11) compared to housewives. Rural women whose husband lived overseas were almost two times more likely to have any HPV infection (OR = 1.93; 95% CI 1.05-3.55) compared to women whose husbands lived with them. CONCLUSION: The prevalence of HPV infection among Bangladeshi women is similar to other regions of Asia. However, type-specific patterns are different. The study findings will inform the formulation of HPV vaccination policies in Bangladesh, monitoring the impact of vaccination programmes, and the identification of target populations for screening.