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1.  Experiences of professional support during pregnancy and childbirth – a qualitative study of women with type 1 diabetes 
Background
Women with type 1 diabetes are at high risk of complications during both pregnancy and childbirth. Stringent monitoring of blood sugar is required in order to improve the chance of giving birth to a healthy child; however, this increases the incidence of severe hypoglycaemia. The aim of this study was to explore the need for and experience of professional support during pregnancy and childbirth among women with type 1 diabetes.
Methods
The study has a lifeworld research approach. Six focus groups and four individual interviews were conducted with 23 women, 6–24 months after delivery. The participants were encouraged to narrate their experiences of pregnancy and childbirth in relation to glycaemic control, well-being and provided care. Data analysis was directed towards discovering qualitative meanings by identifying and clustering meaning units in the text. Further analysis identified eight themes of meaning, classified under pregnancy or childbirth, forming a basis for a final whole interpretation of the explored phenomenon.
Results
The women felt worry about jeopardizing the baby's health and this was sometimes made worse by care providers' manner and lack of competence and support. The increased attention from care providers during pregnancy was experienced as related to the health of the unborn child; not the mothers. Women who during pregnancy received care in a disconnected diabetes organisation were forced to act as messengers between different care providers.
Conclusion
Clarity in terms of defining responsibilities is necessary during pregnancy and childbirth, both among care providers and between the woman and the care provider. Furthermore, a decision must be made concerning how to delegate, transfer or share diabetes responsibility during labour between the care providers and the parents-to-be.
doi:10.1186/1471-2393-9-27
PMCID: PMC2725032  PMID: 19575789
2.  The quality of maternity care services as experienced by women in the Netherlands 
Background
Maternity care is all care in relation to pregnancy, childbirth and the postpartum period. In the Netherlands maternity care is provided by midwives and general practitioners (GPs) in primary care and midwives and gynecologists in secondary care. To be able to interpret women's experience with the quality of maternity care, it is necessary to take into account their 'care path', that is: their route through the care system.
In the Netherlands a new tool is being developed to evaluate the quality of care from the perspective of clients. The tool is called: 'Consumer Quality Index' or CQI and is, within a standardized and systematic framework, tailored to specific health care issues.
Within the framework of developing a CQI Maternity Care, data were gathered about the care women in the Netherlands received during pregnancy, childbirth, and the postpartum period. In this paper the quality of maternity care in the Netherlands is presented, as experienced by women at different stages of their care path.
Methods
A sample of 1,248 pregnant clients of four insurance companies, with their due date in early April 2007, received a postal survey in the third trimester of pregnancy (response 793). Responders to the first questionnaire received a second questionnaire twelve weeks later, on average four weeks after delivery (response 632). Based on care provider and place of birth the 'care path' of the women is described. With factor analysis and reliability analysis five composite measures indicating the quality of treatment by the care provider at different stages of the care path have been constructed. Overall ratings relate to eight different aspects of care, varying from antenatal care by a midwife or GP to care related to neonatal screening.
Results
41.5 percent of respondents remained in primary care throughout pregnancy, labor, birth and the postpartum period, receiving care from a midwife or general practitioner, 31.3% of respondents gave birth at home. The majority of women (58.5%) experienced referral from one care provider to another, i.e. from primary to secondary care or reverse, at least once. All but two percent of women had one or more ultrasound scans during pregnancy. The composite measures for the quality of treatment in different settings and by different care providers showed that women, regardless of parity, were very positive about the quality of the maternity care they received. Quality-of-treatment scores were high: on average 3.75 on a scale ranging from 1 to 4. Overall ratings on a 0 – 10 scale for quality of care during the antenatal period and during labor, birth and the postpartum period were high as well, on average 8.36.
Conclusion
The care path of women in maternity care was seldom straight forward. The majority of pregnant women switched from primary to secondary care and back at least once, during pregnancy or during labor and birth or both.
The results of the quality measures indicate that the quality of care as experienced by women is high throughout the care system. But with regard to the care during labor and birth the quality of care scores are higher when women know their care provider, when they give birth at home, when they give birth in primary care and when they are assisted by their own midwife.
doi:10.1186/1471-2393-9-18
PMCID: PMC2689853  PMID: 19426525
3.  Factors associated with tocolytic hospitalizations in Taiwan: evidence from a population-based and longitudinal study from 1997 to 2004 
Background
The use of tocolytic hospitalization in antenatal care is controversial and worthy of more research. We investigated individual, institutional, and area factors that affect the use of tocolytic hospitalizations in Taiwan where fertility has rapidly declined.
Methods
Longitudinal data from the 1996 to 2004 National Health Insurance Research Database in Taiwan were used to identify tocolytic hospitalizations. The probit model was used to estimate factors associated with tocolytic hospitalizations.
Results
The decline in fertility was significantly associated with the probability of tocolytic hospitalizations. Several physician and institutional factors-including physician's age, hospital ownership, accreditation status, bed size, and teaching status-were also significantly correlated to the dependent variables.
Conclusions
The provision of inpatient tocolysis is influenced not only by clinical considerations but also by physician, institutional, and area factors unrelated to clinical need. Fertility declines in Taiwan may have led obstetricians/gynecologists to provide more tocolysis to make up for their lost income. If the explanation is further validated, reimbursement policies may need to be reviewed to correct for overuse of inpatient tocolysis. The correlation could also be explained by the increasing use of artificial reproductive technologies and higher social value of newborns. In addition, the physician and institutional variations observed in the study indicate potential misuse of inpatient tocolysis that warrant further investigation.
doi:10.1186/1471-2393-9-59
PMCID: PMC2806362  PMID: 20021650
4.  Making stillbirths count, making numbers talk - Issues in data collection for stillbirths 
Background
Stillbirths need to count. They constitute the majority of the world's perinatal deaths and yet, they are largely invisible. Simply counting stillbirths is only the first step in analysis and prevention. From a public health perspective, there is a need for information on timing and circumstances of death, associated conditions and underlying causes, and availability and quality of care. This information will guide efforts to prevent stillbirths and improve quality of care.
Discussion
In this report, we assess how different definitions and limits in registration affect data capture, and we discuss the specific challenges of stillbirth registration, with emphasis on implementation. We identify what data need to be captured, we suggest a dataset to cover core needs in registration and analysis of the different categories of stillbirths with causes and quality indicators, and we illustrate the experience in stillbirth registration from different cultural settings. Finally, we point out gaps that need attention in the International Classification of Diseases and review the qualities of alternative systems that have been tested in low- and middle-income settings.
Summary
Obtaining high-quality data will require consistent definitions for stillbirths, systematic population-based registration, better tools for surveys and verbal autopsies, capacity building and training in procedures to identify causes of death, locally adapted quality indicators, improved classification systems, and effective registration and reporting systems.
doi:10.1186/1471-2393-9-58
PMCID: PMC2805601  PMID: 20017922
5.  Strategies for recruiting Hispanic women into a prospective cohort study of modifiable risk factors for gestational diabetes mellitus 
Background
The purpose of this article was to describe effective strategies for recruitment of Hispanic women into a prospective cohort study of modifiable risk factors for gestational diabetes mellitus (GDM). Although Hispanic women have two to four times the risk of developing GDM compared with non-Hispanic white women, few GDM prevention studies have included Hispanic women.
Methods
The study was conducted in the ambulatory obstetrical practices of Baystate Medical Center located in a socioeconomically and ethnically diverse city in Massachusetts. The study employed a range of strategies to recruit Hispanic women based on a review of the literature as well as prior experience with the study population.
Results
Over a period of 32 months, a total of 851 Hispanic prenatal care patients were recruited. Among eligible women, 52.4% agreed to participate. Participants were young (70% <25 years), with low levels of education, and on public health insurance (81.5%); 88% were unmarried. Study design features such as use of bilingual recruiters, a flexible recruitment process, training recruiters to be culturally sensitive, use of culturally tailored materials, prescreening participants, participant compensation, seeking the cooperation of clinic staff, and continuous monitoring of recruitment goals emerged as important issues influencing recruitment.
Conclusions
Findings suggest that investigators can successfully recruit pregnant women from ethnic minority groups of low socioeconomic status into observational studies. The study provides culturally appropriate recruitment strategies useful for practice-based settings recruiting Hispanic research participation.
doi:10.1186/1471-2393-9-57
PMCID: PMC2799379  PMID: 20003350
6.  Early pregnancy peripheral blood gene expression and risk of preterm delivery: a nested case control study 
Background
Preterm delivery (PTD) is a significant public health problem associated with greater risk of mortality and morbidity in infants and mothers. Pathophysiologic processes that may lead to PTD start early in pregnancy. We investigated early pregnancy peripheral blood global gene expression and PTD risk.
Methods
As part of a prospective study, ribonucleic acid was extracted from blood samples (collected at 16 weeks gestational age) from 14 women who had PTD (cases) and 16 women who delivered at term (controls). Gene expressions were measured using the GeneChip® Human Genome U133 Plus 2.0 Array. Student's T-test and fold change analysis were used to identify differentially expressed genes. We used hierarchical clustering and principle components analysis to characterize signature gene expression patterns among cases and controls. Pathway and promoter sequence analyses were used to investigate functions and functional relationships as well as regulatory regions of differentially expressed genes.
Results
A total of 209 genes, including potential candidate genes (e.g. PTGDS, prostaglandin D2 synthase 21 kDa), were differentially expressed. A set of these genes achieved accurate pre-diagnostic separation of cases and controls. These genes participate in functions related to immune system and inflammation, organ development, metabolism (lipid, carbohydrate and amino acid) and cell signaling. Binding sites of putative transcription factors such as EGR1 (early growth response 1), TFAP2A (transcription factor AP2A), Sp1 (specificity protein 1) and Sp3 (specificity protein 3) were over represented in promoter regions of differentially expressed genes. Real-time PCR confirmed microarray expression measurements of selected genes.
Conclusions
PTD is associated with maternal early pregnancy peripheral blood gene expression changes. Maternal early pregnancy peripheral blood gene expression patterns may be useful for better understanding of PTD pathophysiology and PTD risk prediction.
doi:10.1186/1471-2393-9-56
PMCID: PMC2799378  PMID: 20003277
7.  Trends in postpartum hemorrhage in high resource countries: a review and recommendations from the International Postpartum Hemorrhage Collaborative Group 
Background
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity worldwide. Several recent publications have noted an increasing trend in incidence over time. The international PPH collaboration was convened to explore the observed trends and to set out actions to address the factors identified.
Methods
We reviewed available data sources on the incidence of PPH over time in Australia, Belgium, Canada, France, the United Kingdom and the USA. Where information was available, the incidence of PPH was stratified by cause.
Results
We observed an increasing trend in PPH, using heterogeneous definitions, in Australia, Canada, the UK and the USA. The observed increase in PPH in Australia, Canada and the USA was limited solely to immediate/atonic PPH. We noted increasing rates of severe adverse outcomes due to hemorrhage in Australia, Canada, the UK and the USA.
Conclusion
Key Recommendations
1. Future revisions of the International Classification of Diseases should include separate codes for atonic PPH and PPH immediately following childbirth that is due to other causes. Also, additional codes are required for placenta accreta/percreta/increta.
2. Definitions of PPH should be unified; further research is required to investigate how definitions are applied in practice to the coding of data.
3. Additional improvement in the collection of data concerning PPH is required, specifically including a measure of severity.
4. Further research is required to determine whether an increased rate of reported PPH is also observed in other countries, and to further investigate potential risk factors including increased duration of labor, obesity and changes in second and third stage management practice.
5. Training should be provided to all staff involved in maternity care concerning assessment of blood loss and the monitoring of women after childbirth. This is key to reducing the severity of PPH and preventing any adverse outcomes.
6. Clinicians should be more vigilant given the possibility that the frequency and severity of PPH has in fact increased. This applies particularly to small hospitals with relatively few deliveries where management protocols may not be defined adequately and drugs or equipment may not be on hand to deal with unexpected severe PPH.
doi:10.1186/1471-2393-9-55
PMCID: PMC2790440  PMID: 19943928
8.  Newborn care practices among slum dwellers in Dhaka, Bangladesh: a quantitative and qualitative exploratory study 
Background
Urbanization is occurring at a rapid pace, especially in low-income countries. Dhaka, Bangladesh, is estimated to grow to 50 million by 2015, with 21 million living in urban slums. Although health services are available, neonatal mortality is higher in slum areas than in urban non-slum areas. The Manoshi program works to improve maternal, newborn, and child health in urban slums in Bangladesh. This paper describes newborn care practices in urban slums in Dhaka and provides program recommendations.
Methods
A quantitative baseline survey was conducted in six urban slum areas to measure newborn care practices among recently delivered women (n = 1,256). Thirty-six in-depth semi-structured interviews were conducted to explore newborn care practices among currently pregnant women (n = 18) and women who had at least one delivery (n = 18).
Results
In the baseline survey, the majority of women gave birth at home (84%). Most women reported having knowledge about drying the baby (64%), wrapping the baby after birth (59%), and cord care (46%). In the in-depth interviews, almost all women reported using sterilized instruments to cut the cord. Babies are typically bathed soon after birth to purify them from the birth process. There was extensive care given to the umbilical cord including massage and/or applying substances, as well as a variety of practices to keep the baby warm. Exclusive breastfeeding was rare; most women reported first giving their babies sweet water, honey and/or other foods.
Conclusion
These reported newborn care practices are similar to those in rural areas of Bangladesh and to urban and rural areas in the South Asia region. There are several program implications. Educational messages to promote providing newborn care immediately after birth, using sterile thread, delaying bathing, and ensuring dry cord care and exclusive breastfeeding are needed. Programs in urban slum areas should also consider interventions to improve social support for women, especially first time mothers. These interventions may improve newborn survival and help achieve MDG4.
doi:10.1186/1471-2393-9-54
PMCID: PMC2784437  PMID: 19919700
9.  Surprisingly low compliance to local guidelines for risk factor based screening for gestational diabetes mellitus - A population-based study 
Background
Screening for gestational diabetes mellitus (GDM) is routine during pregnancy in many countries in the world. The screening programs are either based on general screening offered to all pregnant women or risk factor based screening stipulated in local clinical guidelines. The aims of this study were to investigate: 1) the compliance with local guidelines of screening for GDM and 2) the outcomes of pregnancy and birth in relation to risk factors of GDM and whether or not exposed to oral glucose tolerance test (OGTT).
Methods
This study design was a population-based retrospective cross-sectional study of 822 women. A combination of questionnaire data and data collected from medical records was applied. Compliance to the local guidelines of risk factor based screening for GDM was examined and a comparison of outcomes of pregnancy and delivery in relation to risk factor groups for GDM was performed.
Results
Of the 822 participants, 257 (31.3%) women fulfilled at least one criterion for being exposed to screening for GDM according to the local clinical guidelines. However, only 79 (30.7%) of these women were actually exposed to OGTT and of those correctly exposed for screening, seven women were diagnosed with GDM. Women developing risk factors for GDM during pregnancy had a substantially increased risk of giving birth to an infant with macrosomia.
Conclusion
Surprisingly low compliance with the local clinical guidelines for screening for GDM during pregnancy was found. Furthermore, the prevalence of the risk factors of GDM in our study was almost doubled compared to previous Swedish studies. Pregnant women developing risk factors of GDM during pregnancy were found to be at substantially increased risk of giving birth to an infant with macrosomia. There is a need of actions improving compliance to the local guidelines.
doi:10.1186/1471-2393-9-53
PMCID: PMC2784436  PMID: 19917091
10.  Residential mobility during pregnancy in the north of England 
Background
Many epidemiological studies assign exposure to an individual's residence at a single time point, such as birth or death. This approach makes no allowance for migration and may result in exposure error, leading to reduced study power and biased risk estimates. Pregnancy outcomes are less susceptible to this bias, however data from North American populations indicate that pregnant women are a highly mobile group. We assessed mobility in pregnant women in the north of England using data from the Northern Congenital Abnormality Survey (NorCAS).
Methods
Data were extracted from NorCAS for 1985 to 2003. Eligible cases had a gestational age at delivery of ≥ 24 weeks (a viable delivery) (n = 11 559). We assessed mobility between booking appointment (average gestational age 13 weeks) and delivery for pregnancies where the address at booking appointment and delivery were known. The impacts on mobility of maternal age and area-level socio-economic indicators were explored using standard descriptive statistics. A sensitivity analysis and a small validation exercise were undertaken to assess the impact of missing data on the estimate of mobility.
Results
Out of 7 919 eligible cases for whom addresses at booking and delivery were known, 705 (8.9% (95% CI 8.3 - 9.5)) moved between booking and delivery; the mean and median moving distance was 9.7 and 1.4 km respectively. Movers were significantly younger (25.4 versus 27.3 years, p < 0.01) and lived in more deprived areas (index of multiple deprivation score 38.3 versus 33.7, p < 0.01) than non movers.
Conclusion
Mobility in the north of England (9%) is considerably lower than that reported in North America and the only other study from the UK (23%). Consistent with other studies, mobility was related to maternal age and socio-economic status, and the majority of moves were over a relatively short distance. Although this population appears relatively stable, the mobility we have observed may still introduce misclassification or error into an exposure assessment relying solely on postcode at delivery, and migration should still therefore be considered a potential source of bias in future studies.
doi:10.1186/1471-2393-9-52
PMCID: PMC2784435  PMID: 19912662
11.  Maternal morbidity in the first year after childbirth in Mombasa Kenya; a needs assessment 
Background
In sub-Saharan Africa, few services specifically address the needs of women in the first year after childbirth. By assessing the health status of women in this period, key interventions to improve maternal health could be identified. There is an underutilised opportunity to include these interventions within the package of services provided for woman-child pairs attending child-health clinics.
Methods
This needs assessment entailed a cross-sectional survey with 500 women attending a child-health clinic at the provincial hospital in Mombasa, Kenya. A structured questionnaire, clinical examination, and collection of blood, urine, cervical swabs and Pap smear were done. Women's health care needs were compared between the early (four weeks to two months after childbirth), middle (two to six months) and late periods (six to twelve months) since childbirth.
Results
More than one third of women had an unmet need for contraception (39%, 187/475). Compared with other time intervals, women in the late period had more general health symptoms such as abdominal pain, fever and depression, but fewer urinary or breast problems. Over 50% of women in each period had anaemia (Hb <11 g/l; 265/489), with even higher levels of anaemia in those who had a caesarean section or had not received iron supplementation during pregnancy. Bacterial vaginosis was present in 32% (141/447) of women, while 1% (5/495) had syphilis, 8% (35/454) Trichomonas vaginalis and 11% (54/496) HIV infection.
Conclusion
Throughout the first year after childbirth, women had high levels of morbidity. Interface with health workers at child health clinics should be used for treatment of anaemia, screening and treatment of reproductive tract infections, and provision of family planning counselling and contraception. Providing these services during visits to child health clinics, which have high coverage both early and late in the year after childbirth, could make an important contribution towards improving women's health.
doi:10.1186/1471-2393-9-51
PMCID: PMC2777848  PMID: 19891784
12.  Developing and pre-testing a decision board to facilitate informed choice about delivery approach in uncomplicated pregnancy 
Background
The rate of caesarean sections is increasing worldwide, yet medical literature informing women with uncomplicated pregnancies about relative risks and benefits of elective caesarean section (CS) compared with vaginal delivery (VD) remains scarce. A decision board may address this gap, providing systematic evidence-based information so that patients can more fully understand their treatment options. The objective of our study was to design and pre-test a decision board to guide clinical discussions and enhance informed decision-making related to delivery approach (CS or VD) in uncomplicated pregnancy.
Methods
Development of the decision board involved two preliminary studies to determine women's preferred mode of risk presentation and a systematic literature review for the most comprehensive presentation of medical risks at the time (VD and CS). Forty women were recruited to pre-test the tool. Eligible subjects were of childbearing age (18-40 years) but were not pregnant in order to avoid raising the expectation among pregnant women that CS was a universally available birth option. Women selected their preferred delivery approach and completed the Decisional Conflict Scale to measure decisional uncertainty before and after reviewing the decision board. They also answered open-ended questions reflecting what they had learned, whether or not the information had helped them to choose between birth methods, and additional information that should be included. Descriptive statistics were used to analyse sample characteristics and women's choice of delivery approach pre/post decision board. Change in decisional conflict was measured using Wilcoxon's sign rank test for each of the three subscales.
Results
The majority of women reported that they had learned something new (n = 37, 92%) and that the tool had helped them make a hypothetical choice between delivery approaches (n = 34, 85%). Women wanted more information about neonatal risks and personal experiences. Decisional uncertainty decreased (p < 0.001) and perceived effectiveness of decisions increased (p < 0.001) post-intervention.
Conclusion
Non-pregnant women of childbearing age were positive about the decision board and stated their hypothetical delivery choices were informed by risk presentation, but wanted additional information about benefits and experiences. This study represents a preliminary but integral step towards ensuring women considering delivery approaches in uncomplicated pregnancies are fully informed.
doi:10.1186/1471-2393-9-50
PMCID: PMC2774286  PMID: 19874628
13.  Mary Crosse project: systematic reviews and grading the value of neonatal tests in predicting long term outcomes 
Background
Events before birth, condition at birth, events immediately following birth, and condition in early childhood are linked together, and have implications for health and disease in adulthood. At present, there is lack of clarity about the tests that purport to link these various stages. This is partly because there is paucity of collated information about the best strategies for predicting longer-term outcomes before (using tests in fetal period) or after birth (using tests in neonatal period, infancy as well as early childhood).
Methods/Design
A series of systematic reviews and meta-analyses will be undertaken to determine, amongst neonates, the ability of various tests and measures to predict infant, childhood and adult outcomes. We will search Medline, Embase, Cochrane Library, MEDION, citation lists of review articles and eligible primary articles and will contact experts in the field. Independent reviewers will select studies, extract data and assess study quality according to established criteria. Language restrictions will not be applied. Data synthesis will involve meta-analysis (where appropriate), exploration of heterogeneity and publication bias. Evidence collated will be graded for its quality to support decision making.
Discussion
The project will collate, synthesise and evaluate the available evidence concerning the value of tests of neonatal wellbeing to predict long term outcomes. The systematic reviews will assess the quality of available evidence and identify tests with the strongest association with outcomes, and assess their economic value. The output of this project will help formulate practice recommendations.
doi:10.1186/1471-2393-9-49
PMCID: PMC2774285  PMID: 19874579
14.  Treatment of retained placenta with misoprostol: a randomised controlled trial in a low-resource setting (Tanzania) 
Background
Retained placenta is one of the common causes of maternal mortality in developing countries where access to appropriate obstetrical care is limited. Current treatment of retained placenta is manual removal of the placenta under anaesthesia, which can only take place in larger health care facilities. Medical treatment of retained placenta with prostaglandins E1 (misoprostol) could be cost-effective and easy-to-use and could be a life-saving option in many low-resource settings. The aim of this study is to assess the efficacy and safety of sublingually administered misoprostol in women with retained placenta in a low resource setting.
Methods
Design: Multicentered randomised, double-blind, placebo-controlled trial, to be conducted in 5 hospitals in Tanzania, Africa.
Inclusion criteria: Women with retained placenta, at a gestational age of 28 weeks or more and blood loss less than 750 ml, 30 minutes after delivery of the newborn despite active management of third stage of labour.
Trial Entry & Randomisation & Study Medication: After obtaining informed consent, eligible women will be allocated randomly to the treatment groups using numbered envelopes that will be randomized in variable blocks containing identical capsules with either 800 microgram of misoprostol or placebo. The drugs will be given sublingually. The women, maternal care providers and researchers will be blinded to treatment allocation.
Sample Size: 117 women, to show a 40% reduction in manual removals of the placenta (p = 0.05, 80% power). The randomization will be misoprostol: placebo = 2:1
Primary Study Outcome: Expulsion of the placenta without manual removal. Secondary outcome is the number of blood transfusions.
Discussion
This is a protocol for a randomized trial in a low resource setting to assess if medical treatment of women with retained placenta with misoprostol reduces the incidence of manual removal of the placenta.
Clinical Trial Registration
Current Controlled Trials ISRCTN16104753
doi:10.1186/1471-2393-9-48
PMCID: PMC2770987  PMID: 19852814
15.  A case study evaluation of implementation of a care pathway to support normal birth in one English birth centre: anticipated benefits and unintended consequences 
Background
The policy drive for the UK National Health Service (NHS) has focused on the need for high quality services informed by evidence of best practice. The introduction of care pathways and protocols to standardise care and support implementation of evidence into practice has taken place across the NHS with limited evaluation of their impact. A multi-site case study evaluation was undertaken to assess the impact of use of care pathways and protocols on clinicians, service users and service delivery. One of the five sites was a midwifery-led Birth Centre, where an adapted version of the All Wales Clinical Pathway for Normal Birth had been implemented.
Methods
The overarching framework was realistic evaluation. A case study design enabled the capture of data on use of the pathway in the clinical setting, use of multiple methods of data collection and opportunity to study and understand the experiences of clinicians and service users whose care was informed by the pathway. Women attending the Birth Centre were recruited at their 36 week antenatal visit. Episodes of care during labour were observed, following which the woman and the midwife who cared for her were interviewed about use of the pathway. Interviews were also held with other key stakeholders from the study site. Qualitative data were content analysed.
Results
Observations were undertaken of four women during labour. Eighteen interviews were conducted with clinicians and women, including the women whose care was observed and the midwives who cared for them, senior midwifery managers and obstetricians. The implementation of the pathway resulted in a number of anticipated benefits, including increased midwifery confidence in skills to support normal birth and promotion of team working. There were also unintended consequences, including concerns about a lack of documentation of labour care and negative impact on working relationships with obstetric and other midwifery colleagues. Women were unaware their care was informed by a care pathway.
Conclusion
Care pathways are complex interventions which generate a number of consequences for practice. Those considering introduction of pathways need to ensure all relevant stakeholders are engaged with this and develop robust evaluation strategies to accompany implementation.
doi:10.1186/1471-2393-9-47
PMCID: PMC2761848  PMID: 19804624
16.  Measuring the costs of outreach motivational interviewing for smoking cessation and relapse prevention among low-income pregnant women 
Background
Economic theory provides the philosophical foundation for valuing costs in judging medical and public health interventions. When evaluating smoking cessation interventions, accurate data on costs are essential for understanding resource consumption. Smoking cessation interventions, for which prior data on resource costs are typically not available, present special challenges. We develop a micro-costing methodology for estimating the real resource costs of outreach motivational interviewing (MI) for smoking cessation and relapse prevention among low-income pregnant women and report results from a randomized controlled trial (RCT) employing the methodology. Methodological standards in cost analysis are necessary for comparison and uniformity in analysis across interventions. Estimating the costs of outreach programs is critical for understanding the economics of reaching underserved and hard-to-reach populations.
Methods
Randomized controlled trial (1997-2000) collecting primary cost data for intervention. A sample of 302 low-income pregnant women was recruited from multiple obstetrical sites in the Boston metropolitan area. MI delivered by outreach health nurses vs. usual care (UC), with economic costs as the main outcome measures.
Results
The total cost of the MI intervention for 156 participants was $48,672 or $312 per participant. The total cost of $311.8 per participant for the MI intervention compared with a cost of $4.82 per participant for usual care, a difference of $307 ([CI], $289.2 to $322.8). The total fixed costs of the MI were $3,930 and the total variable costs of the MI were $44,710. The total expected program costs for delivering MI to 500 participants would be 147,430, assuming no economies of scale in program delivery. The main cost components of outreach MI were intervention delivery, travel time, scheduling, and training.
Conclusion
Grounded in economic theory, this methodology systematically identifies and measures resource utilization, using a process tracking system and calculates both component-specific and total costs of outreach MI. The methodology could help improve collection of accurate data on costs and estimates of the real resource costs of interventions alongside clinical trials and improve the validity and reliability of estimates of resource costs for interventions targeted at underserved and hard-to-reach populations.
doi:10.1186/1471-2393-9-46
PMCID: PMC2761847  PMID: 19775455
17.  Introduction of a qualitative perinatal audit at Muhimbili National Hospital, Dar es Salaam, Tanzania 
Background
Perinatal death is a devastating experience for the mother and of concern in clinical practice. Regular perinatal audit may identify suboptimal care related to perinatal deaths and thus appropriate measures for its reduction. The aim of this study was to perform a qualitative perinatal audit of intrapartum and early neonatal deaths and propose means of reducing the perinatal mortality rate (PMR).
Methods
From 1st August, 2007 to 31st December, 2007 we conducted an audit of perinatal deaths (n = 133) with birth weight 1500 g or more at Muhimbili National Hospital (MNH). The audit was done by three obstetricians, two external and one internal auditors. Each auditor independently evaluated the cases narratives. Suboptimal factors were identified in the antepartum, intrapartum and early neonatal period and classified into three levels of delay (community, infrastructure and health care). The contribution of each suboptimal factor to adverse perinatal outcome was identified and the case graded according to possible avoidability. Degree of agreement between auditors was assessed by the kappa coefficient.
Results
The PMR was 92 per 1000 total births. Suboptimal factors were identified in 80% of audited cases and half of suboptimal factors were found to be the likely cause of adverse perinatal outcome and were preventable. Poor foetal heart monitoring during labour was indirectly associated with over 40% of perinatal death. There was a poor to fair agreement between external and internal auditors.
Conclusion
There are significant areas of care that need improvement. Poor monitoring during labour was a major cause of avoidable perinatal mortality. This type of audit was a good starting point for quality assurance at MNH. Regular perinatal audits to identify avoidable causes of perinatal deaths with feed back to the staff may be a useful strategy to reduce perinatal mortality.
doi:10.1186/1471-2393-9-45
PMCID: PMC2754979  PMID: 19765312
18.  Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial 
Background
Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands.
Methods/Design
We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.
The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80.
Discussion
This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies.
Trial registration
Current Controlled Trials: NTR 1858
doi:10.1186/1471-2393-9-44
PMCID: PMC2754434  PMID: 19761606
19.  Determinants of use of maternal health services in Nigeria - looking beyond individual and household factors 
Background
Utilization of maternal health services is associated with improved maternal and neonatal health outcomes. Considering global and national interests in the Millennium Development Goal and Nigeria's high level of maternal mortality, understanding the factors affecting maternal health use is crucial. Studies on the use of maternal care services have largely overlooked community and other contextual factors. This study examined the determinants of maternal services utilization in Nigeria, with a focus on individual, household, community and state-level factors.
Methods
Data from the 2005 National HIV/AIDS and Reproductive Health Survey - an interviewer-administered nationally representative survey - were analyzed to identify individual, household and community factors that were significantly associated with utilization of maternal care services among 2148 women who had a baby during the five years preceding the survey. In view of the nested nature of the data, we used multilevel analytic methods and assessed state-level random effects.
Results
Approximately three-fifths (60.3%) of the mothers used antenatal services at least once during their most recent pregnancy, while 43.5% had skilled attendants at delivery and 41.2% received postnatal care. There are commonalities and differences in the predictors of the three indicators of maternal health service utilization. Education is the only individual-level variable that is consistently a significant predictor of service utilization, while socio-economic level is a consistent significant predictor at the household level. At the community level, urban residence and community media saturation are consistently strong predictors. In contrast, some factors are significant in predicting one or more of the indicators of use but not for all. These inconsistent predictors include some individual level variables (the woman's age at the birth of the last child, ethnicity, the notion of ideal family size, and approval of family planning), a community-level variable (prevalence of the small family norm in the community), and a state-level variable (ratio of PHC to the population).
Conclusion
Factors influencing maternal health services utilization operate at various levels - individual, household, community and state. Depending on the indicator of maternal health services, the relevant determinants vary. Effective interventions to promote maternal health service utilization should target the underlying individual, household, community and policy-level factors. The interventions should reflect the relative roles of the various underlying factors.
doi:10.1186/1471-2393-9-43
PMCID: PMC2754433  PMID: 19754941
20.  Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial) 
Background
Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours.
Methods/Design
The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.
Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05).
Discussion
This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks.
Trial Registration
Clinical trial registration: , NTR 1336, date of registration: June 3rd 2008.
doi:10.1186/1471-2393-9-42
PMCID: PMC2754432  PMID: 19737426
21.  Maternal and neonatal factors associated with mode of delivery under a universal newborn hearing screening programme in Lagos, Nigeria 
Background
Emerging evidence from a recent pilot universal newborn hearing screening (UNHS) programme suggests that the burden of obstetric complications associated with mode of delivery is not limited to maternal and perinatal mortality but may also include outcomes that undermine optimal early childhood development of the surviving newborns. However, the potential pathways for this association have not been reported particularly in the context of a resource-poor setting. This study therefore set out to establish the pattern of delivery and the associated neonatal outcomes under a UNHS programme.
Methods
A cross-sectional study in which all consenting mothers who delivered in an inner-city tertiary maternity hospital in Lagos, Nigeria from May 2005 to December 2007 were enrolled during the UNHS programme. Socio-demographic, obstetric and neonatal factors independently associated with vaginal, elective and emergency caesarean deliveries were determined using multinomial logistic regression analyses.
Results
Of the 4615 mothers enrolled, 2584 (56.0%) deliveries were vaginal, 1590 (34.4%) emergency caesarean and 441 (9.6%) elective caesarean section. Maternal age, parity, social class and all obstetric factors including lack of antenatal care, maternal HIV and multiple gestations were associated with increased risk of emergency caesarean delivery compared with vaginal delivery. Only parity, lack of antenatal care and prolonged/obstructed labour were associated with increased risk of emergency compared with elective caesarean delivery. Infants delivered by vaginal method or by emergency caesarean section were more likely to be associated with the risk of sensorineural hearing loss but less likely to be associated with hyperbilirubinaemia compared with infants delivered by elective caesarean section. Emergency caesarean delivery was also associated with male gender, low five-minute Apgar scores and admission into special care baby unit compared with vaginal or elective caesarean delivery.
Conclusions
The vast majority of caesarean delivery in this population occur as emergencies and are associated with socio-demographic factors as well as several obstetric complications. Mode of delivery is also associated with the risk of sensorineural hearing loss and other adverse birth outcomes that lie on the causal pathways for potential developmental deficits.
doi:10.1186/1471-2393-9-41
PMCID: PMC2749799  PMID: 19732443
22.  The role of cervical Electrical Impedance Spectroscopy in the prediction of the course and outcome of induced labour 
Background
Previous work by us and others had suggested that cervical electrical impedance spectroscopy (EIS) may be predictive of the outcome of induced labour. We sought to determine which probe configuration of the EIS device is predictive of the outcome of induced labour and compare this to digital assessment by the Bishop score.
Methods
In a prospective cohort of 205 women admitted for induction of labour, we used four probes of diameter 3, 6, 9 and 12 mm connected to an impedance meter to measure cervical resistivity (CR) in Ohm.meters at 14 electrical frequencies and compared their values to digital assessment of the cervix by the Bishop score for the prediction of the outcome of induced labour. We tested the association of labour characteristics and outcomes with CR and Bishop score by stepwise multilinear regression analyses, and the accuracy of prediction of categorical clinical outcomes by analysis of the area under the curves (AUC) of derived Receiver Operator Characteristic (ROC) curves.
Results
Of the four CR probe dimensions studied, only the 12 mm probe was predictive of any labour indices. In the frequency range 19 - 156 kHz, CR obtained with this probe was higher in women who delivered by caesarean section (CS) than those who delivered vaginally, and in labours lasting > 24 hrs. Cervical resistivity at 78.1 kHz best predicted vaginal delivery [optimal cut-off <2.25 Ohm.meter, AUC 0.66 (95% CI 0.59-0.72), sensitivity 71.0%, specificity 56.5%, LR+ 1.63, LR- 0.51, P < 0.01] and labour duration >24 hrs [optimal cut-off 2.27 Ω.m, AUC 0.65 (95% CI 0.58, 0.72), sensitivity 71%, specificity 59%, LR+ 1.72, LR- 0.50, P < 0.05]. In contrast digital assessment by the Bishop score neither predicted vaginal delivery nor the duration of labour. However, Bishop score predicted time to onset of labour > 12 hours and induction-delivery interval < 24 hrs [optimal cut-off ≤ 4, AUC 0.8 (95% CI 0.75, 0.86), sensitivity 77%, specificity 76%, LR+ 3.3, LR- 0.3, P < 0.05] whilst CR did not.
Conclusion
Cervical resistivity appears predictive of labour duration and delivery mode following induced labour. However the low predictive values obtained suggest that its current design proffers no immediate clinical utility.
doi:10.1186/1471-2393-9-40
PMCID: PMC3224746  PMID: 19725953
23.  Optimism/pessimism and health-related quality of life during pregnancy across three continents: a matched cohort study in China, Ghana, and the United States 
Background
Little is known about how optimism/pessimism and health-related quality of life compare across cultures.
Methods
Three samples of pregnant women in their final trimester were recruited from China, Ghana, and the United States (U.S.). Participants completed a survey that included the Life Orientation Test - Revised (LOT-R, an optimism/pessimism measure), the Short Form 12 (SF-12, a quality of life measure), and questions addressing health and demographic factors. A three-country set was created for analysis by matching women on age, gestational age at enrollment, and number of previous pregnancies. Anovas with post-hoc pairwise comparisons were used to compare results across the cohorts. Multivariate regression analysis was used to create a model to identify those variables most strongly associated with optimism/pessimism.
Results
LOT-R scores varied significantly across cultures in these samples, with Ghanaian pregnant women being the most optimistic and least pessimistic and Chinese pregnant women being the least optimistic overall and the least pessimistic in subscale analysis. Four key variables predicted approximately 20% of the variance in overall optimism scores: country of origin (p = .006), working for money (p = .05); level of education (p = .002), and ever being treated for emotional issues with medication (p < .001). Quality of life scores also varied by country in these samples, with the most pronounced difference occurring in the vitality measure. U.S. pregnant women reported far lower vitality scores than both Chinese and Ghanaian pregnant women in our sample.
Conclusion
This research raises important questions regarding what it is about country of origin that so strongly influences optimism/pessimism among pregnant women. Further research is warranted exploring underlying conceptualization of optimism/pessimism and health related quality of life across countries.
doi:10.1186/1471-2393-9-39
PMCID: PMC2744663  PMID: 19723332
24.  Cost-effectiveness of fibronectin testing in a triage in women with threatened preterm labor: alleviation of pregnancy outcome by suspending tocolysis in early labor (APOSTEL-I trial) 
Background
At present, women with threatened preterm labor before 32 weeks of gestation are, after transfer to a perinatal center, treated with tocolytics and corticosteroids. Many of these women are treated unnecessarily. Fibronectin is an accurate predictor for the occurrence of preterm birth among women with threatened preterm labor. We will assess whether triage of these women with fibronectin testing, cervical length or their combination is cost-effective.
Methods/Design
We will investigate a prospective cohort of women referred to a perinatal centre for spontaneous threatened preterm labor between 24 and 34 weeks with intact membranes. All women will be tested for fibronectin and cervical length. Women with a cervical length <10 mm and women with a cervical length between 10-30 mm in combination with a positive fibronectin test will be treated with tocolytics according to local protocol. Women with a cervical length between 10-30 mm in combination with a negative fibronectin test will be randomised between treatment with nifedipine (intervention) and placebo (control) for 48 hours. Women with a cervical length > 30 mm will be managed according to local protocol. Corticosteroids may be given to all women at the discretion of the attending physician. Primary outcome measure will be delivery within 7 days. Secondary outcome measures will be neonatal morbidity and mortality, complications of tocolytics, costs and health related quality of life. The analysis will be according to the intention to treat principle. We anticipate the probability on preterm birth within 7 days in the group of women with a negative fibronectine test to be 5%. Two groups of 110 women will be needed to assure that in case of non-inferiority the difference in the proportion of preterm deliveries < 7 days will be within a prespecified boundary of 7.5% (one sided test, β 0.2, α 0.05). Data obtained from women with a positive and negative fibronectin tests in both the cohort study and the trial will be integrated in a cost-effectiveness analysis that will assess economic consequences of the use of fibronectin.
Discussion
This study will provide evidence for the use of fibronectin testing as safe and cost-effective method in a triage for threatened preterm labor.
Trial registration
Nederlands Trial Register (NTR) number 1857, .
doi:10.1186/1471-2393-9-38
PMCID: PMC2752451  PMID: 19723320
25.  Obesity prevalence in a cohort of women in early pregnancy from a neighbourhood perspective 
Background
The evidence of an association between neighbourhood deprivation and overweight is established for different populations. However no previous studies on neighbourhood variations in obesity in pregnant women were found. In this study we aimed to determine whether obesity during early pregnancy varied by neighbourhood economic status.
Methods
A register based study on 94,323 primiparous pregnant women in 586 Swedish neighbourhoods during the years 1992-2001. Multilevel technique was used to regress obesity prevalence on socioeconomic individual-level variables and the neighbourhood economic status. Five hundred and eighty-six neighbourhoods in the three major cities of Sweden, Stockholm, Göteborg and Malmö, during 1992-2001, were included. The majority of neighbourhoods had a population of 4 000-10 000 inhabitants.
Results
Seven per cent of the variation in obesity prevalence was at the neighbourhood level and the odds of being obese were almost doubled in poor areas.
Conclusion
Our findings supports a community approach in the prevention of obesity in general and thus also in pregnant women.
doi:10.1186/1471-2393-9-37
PMCID: PMC2744903  PMID: 19706158

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