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1.  Global report on preterm birth and stillbirth (2 of 7): discovery science 
BMC Pregnancy and Childbirth  2010;10(Suppl 1):S2.
Background
Normal and abnormal processes of pregnancy and childbirth are poorly understood. This second article in a global report explains what is known about the etiologies of preterm births and stillbirths and identifies critical gaps in knowledge. Two important concepts emerge: the continuum of pregnancy, beginning at implantation and ending with uterine involution following birth; and the multifactorial etiologies of preterm birth and stillbirth. Improved tools and data will enable discovery scientists to identify causal pathways and cost-effective interventions.
Pregnancy and parturition continuum
The biological process of pregnancy and childbirth begins with implantation and, after birth, ends with the return of the uterus to its previous state. The majority of pregnancy is characterized by rapid uterine and fetal growth without contractions. Yet most research has addressed only uterine stimulation (labor) that accounts for <0.5% of pregnancy.
Etiologies
The etiologies of preterm birth and stillbirth differ by gestational age, genetics, and environmental factors. Approximately 30% of all preterm births are indicated for either maternal or fetal complications, such as maternal illness or fetal growth restriction. Commonly recognized pathways leading to preterm birth occur most often during the gestational ages indicated: (1) inflammation caused by infection (22-32 weeks); (2) decidual hemorrhage caused by uteroplacental thrombosis (early or late preterm birth); (3) stress (32-36 weeks); and (4) uterine overdistention, often caused by multiple fetuses (32-36 weeks). Other contributors include cervical insufficiency, smoking, and systemic infections. Many stillbirths have similar causes and mechanisms. About two-thirds of late fetal deaths occur during the antepartum period; the other third occur during childbirth. Intrapartum asphyxia is a leading cause of stillbirths in low- and middle-income countries.
Recommendations
Utilizing new systems biology tools, opportunities now exist for researchers to investigate various pathways important to normal and abnormal pregnancies. Improved access to quality data and biological specimens are critical to advancing discovery science. Phenotypes, standardized definitions, and uniform criteria for assessing preterm birth and stillbirth outcomes are other immediate research needs.
Conclusion
Preterm birth and stillbirth have multifactorial etiologies. More resources must be directed toward accelerating our understanding of these complex processes, and identifying upstream and cost-effective solutions that will improve these pregnancy outcomes.
doi:10.1186/1471-2393-10-S1-S2
PMCID: PMC2841774  PMID: 20233383
2.  Global report on preterm birth and stillbirth (3 of 7): evidence for effectiveness of interventions 
BMC Pregnancy and Childbirth  2010;10(Suppl 1):S3.
Introduction
Interventions directed toward mothers before and during pregnancy and childbirth may help reduce preterm births and stillbirths. Survival of preterm newborns may also be improved with interventions given during these times or soon after birth. This comprehensive review assesses existing interventions for low- and middle-income countries (LMICs).
Methods
Approximately 2,000 intervention studies were systematically evaluated through December 31, 2008. They addressed preterm birth or low birth weight; stillbirth or perinatal mortality; and management of preterm newborns. Out of 82 identified interventions, 49 were relevant to LMICs and had reasonable amounts of evidence, and therefore selected for in-depth reviews. Each was classified and assessed by the quality of available evidence and its potential to treat or prevent preterm birth and stillbirth. Impacts on other maternal, fetal, newborn or child health outcomes were also considered. Assessments were based on an adaptation of the Grades of Recommendation Assessment, Development and Evaluation criteria.
Results
Most interventions require additional research to improve the quality of evidence. Others had little evidence of benefit and should be discontinued. The following are supported by moderate- to high-quality evidence and strongly recommended for LMICs:
• Two interventions prevent preterm births—smoking cessation and progesterone
• Eight interventions prevent stillbirths—balanced protein energy supplementation, screening and treatment of syphilis, intermittant presumptive treatment for malaria during pregnancy, insecticide-treated mosquito nets, birth preparedness, emergency obstetric care, cesarean section for breech presentation, and elective induction for post-term delivery
• Eleven interventions improve survival of preterm newborns—prophylactic steroids in preterm labor, antibiotics for PROM, vitamin K supplementation at delivery, case management of neonatal sepsis and pneumonia, delayed cord clamping, room air (vs. 100% oxygen) for resuscitation, hospital-based kangaroo mother care, early breastfeeding, thermal care, and surfactant therapy and application of continued distending pressure to the lungs for respiratory distress syndrome
Conclusion
The research paradigm for discovery science and intervention development must be balanced to address prevention as well as improve morbidity and mortality in all settings. This review also reveals significant gaps in current knowledge of interventions spanning the continuum of maternal and fetal outcomes, and the critical need to generate further high-quality evidence for promising interventions.
doi:10.1186/1471-2393-10-S1-S3
PMCID: PMC2841444  PMID: 20233384
3.  All Our Babies Cohort Study: recruitment of a cohort to predict women at risk of preterm birth through the examination of gene expression profiles and the environment 
Background
Preterm birth is the leading cause of perinatal morbidity and mortality. Risk factors for preterm birth include a personal or familial history of preterm delivery, ethnicity and low socioeconomic status yet the ability to predict preterm delivery before the onset of preterm labour evades clinical practice. Evidence suggests that genetics may play a role in the multi-factorial pathophysiology of preterm birth. The All Our Babies Study is an on-going community based longitudinal cohort study that was designed to establish a cohort of women to investigate how a women's genetics and environment contribute to the pathophysiology of preterm birth. Specifically this study will examine the predictive potential of maternal leukocytes for predicting preterm birth in non-labouring women through the examination of gene expression profiles and gene-environment interactions.
Methods/Design
Collaborations have been established between clinical lab services, the provincial health service provider and researchers to create an interdisciplinary study design for the All Our Babies Study. A birth cohort of 2000 women has been established to address this research question. Women provide informed consent for blood sample collection, linkage to medical records and complete questionnaires related to prenatal health, service utilization, social support, emotional and physical health, demographics, and breast and infant feeding. Maternal blood samples are collected in PAXgene™ RNA tubes between 18-22 and 28-32 weeks gestation for transcriptomic analyses.
Discussion
The All Our Babies Study is an example of how investment in clinical-academic-community partnerships can improve research efficiency and accelerate the recruitment and data collection phases of a study. Establishing these partnerships during the study design phase and maintaining these relationships through the duration of the study provides the unique opportunity to investigate the multi-causal factors of preterm birth. The overall All Our Babies Study results can potentially lead to healthier pregnancies, mothers, infants and children.
doi:10.1186/1471-2393-10-87
PMCID: PMC3022739  PMID: 21192811
4.  Racial disparities in infant mortality: what has birth weight got to do with it and how large is it? 
Background
It has been hypothesized that birth weight is not on the causal pathway to infant mortality, at least among "normal" births (i.e. those located in the central part of the birth weight distribution), and that US racial disparities (African American versus European American) may be underestimated. Here these hypotheses are tested by examining the role of birth weight on racial disparities in infant mortality.
Methods
A two-component Covariate Density Defined mixture of logistic regressions model is used to decompose racial disparities, 1) into disparities due to "normal" versus "compromised" components of the birth cohort, and 2) further decompose these components into indirect effects, which are associated with birth weight, versus direct effects, which are independent of birth weight.
Results
The results indicate that a direct effect is responsible for the racial disparity in mortality among "normal" births. No indirect effect of birth weight is observed despite significant disparities in birth weight. Among "compromised" births, an indirect effect is responsible for the disparity, which is consistent with disparities in birth weight. However, there is also a direct effect among "compromised" births that reduces the racial disparity in mortality. This direct effect is responsible for the "pediatric paradox" and maybe due to differential fetal loss. Model-based adjustment for this effect indicates that racial disparities corrected for fetal loss could be as high as 3 or 4 fold. This estimate is higher than the observed racial disparities in infant mortality (2.1 for both sexes).
Conclusions
The results support the hypothesis that birth weight is not on the causal pathway to infant mortality among "normal" births, although birth weight could play a role among "compromised" births. The overall size of the US racial disparities in infant mortality maybe considerably underestimated in the observed data possibly due to racial disparities in fetal loss.
doi:10.1186/1471-2393-10-86
PMCID: PMC3025864  PMID: 21189146
5.  Self-administered questionnaire versus interview as a screening method for intimate partner violence in the prenatal setting in Japan: A randomised controlled trial 
Background
Intimate partner violence (IPV) is a serious social issue in Japan. In order to start effective interventions for abused women, the appropriate method of screening for IPV in healthcare settings needs clarifying. The objective of this study was to compare the effectiveness of a face-to-face interview with a self-administered questionnaire. We used the Violence Against Women Screen (VAWS), a Japanese screening instrument for intimate partner violence (IPV), for identifying pregnant women who have experienced abuse.
Methods
We conducted a randomised controlled trial to screen participants at three points in time in a prenatal clinic in Tokyo, Japan. There were 328 consenting women between 14 and 25 weeks of pregnancy who were consecutively selected and randomly assigned to either the interview or self-administered questionnaire group. Both groups completed the same screening instrument three times during their pregnancy. The primary outcome was the total number of women identified by each screening method and the secondary outcome was the effect of the screening as measured by the women's comfort level and their expressed need to consult with the nurse.
Results
For all three screenings, the identification rate in the interview group was significantly lower than that for the self-administered questionnaire group (relative risk 0.66, 95% CI 0.46 to 0.97), even after controlling for smoking (adjusted odds ratio 0.59, 95% CI 0.35 to 0.98). The two groups did not differ for secondary outcomes.
Conclusions
The self-administered questionnaire identified more IPV than the face-to-face interview when screening pregnant women in a Japanese prenatal clinic.
Trial Registration
UMIN-CTRC000000353
doi:10.1186/1471-2393-10-84
PMCID: PMC3017017  PMID: 21182802
6.  Increased incidence of glucose disorders during pregnancy is not explained by pre-pregnancy obesity in London, Canada 
Background
The increasing incidence of impaired glucose tolerance (IGT), gestational diabetes (GDM) and type 2 diabetes (T2D) during pregnancy was hypothesized to be associated with increases in pre-pregnancy body mass index (BMI). The aims were to 1) determine the prevalence of IGT/GDM/T2 D over a 10 year period; 2) examine the relationship between maternal overweight/obesity and IGT/GDM/T2D; and 3) examine the extent to which maternal metabolic complications impact maternal and fetal pregnancy outcomes.
Methods
Data arose from a perinatal database which contains maternal characteristics and perinatal outcome for all singleton infants born in London, Canada between January 1, 2000 and December 31, 2009. Univariable and multivariable odds ratios (OR) were estimated using logistic regression with IGT/GDM/T2 D being the outcome of interest.
Results
A total of 36,597 women were included in the analyses. Population incidence of IGT, GDM and T2 D rose from 0.7%, 2.9% and 0.5% in 2000 to 1.2%, 4.2% and 0.9% in 2009. The univariable OR for IGT, GDM and T2 D were 1.65, 1.52 and 2.06, respectively, over the ten year period. After controlling for maternal age, parity and pre-pregnancy BMI the OR did not decrease. Although there was a positive relationship between pre-pregnancy BMI and prevalence of IGT/GDM/T2 D, this did not explain the time trends in the latter. Diagnosis of IGT/GDM/T2 D increased the risk of having an Apgar score <7 at 5 minutes, which was partially explained by gestational hypertension, high placental ratio, gestational age and large for gestational age babies.
Conclusions
We found a significant increase in the incidence of IGT/GDM/T2 D for the decade between 2000-2009 which was not explained by rising prevalence of maternal overweight/obesity.
doi:10.1186/1471-2393-10-85
PMCID: PMC3022738  PMID: 21184681
7.  Well being of obstetric patients on minimal blood transfusions (WOMB trial) 
Background
Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands.
Methods/Design
The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs.
The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%).
Discussion
This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.
Trial registration
ClinicalTrials.gov NCT00335023, Nederlands Trial Register NTR335
doi:10.1186/1471-2393-10-83
PMCID: PMC3022737  PMID: 21162725
8.  Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the global network's EmONC trial) 
Background
Maternal and newborn mortality rates remain unacceptably high, especially where the majority of births occur in home settings or in facilities with inadequate resources. The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes. However, the effectiveness of emergency obstetric and neonatal care services has never been proven. Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes.
Methods/Design
We have developed a cluster-randomized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization, birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities. This trial will take place in 106 clusters (300-500 deliveries per year each) across 7 sites of the Global Network for Women's and Children's Health Research in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. The trial intervention has three key elements, community mobilization, home-based life saving skills for communities and birth attendants, and training of providers at obstetric facilities to improve quality of care. The primary outcome of the trial is perinatal mortality. Secondary outcomes include rates of stillbirth, 7-day neonatal mortality, maternal death or severe morbidity (including obstetric fistula, eclampsia and obstetrical sepsis) and 28-day neonatal mortality.
Discussion
In this trial, we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes. If successful, the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries.
Trial Registration
ClinicalTrials.gov NCT01073488
doi:10.1186/1471-2393-10-82
PMCID: PMC3017016  PMID: 21156060
9.  Childbirth experience questionnaire (CEQ): development and evaluation of a multidimensional instrument 
Background
Negative experiences of first childbirth increase risks for maternal postpartum depression and may negatively affect mothers' attitudes toward future pregnancies and choice of delivery method. Postpartum questionnaires assessing mothers' childbirth experiences are needed to aid in identifying mothers in need of support and counselling and in isolating areas of labour and birth management and care potentially in need of improvement. The aim of this study was to develop and evaluate a questionnaire for assessing different aspects of first-time mothers' childbirth experiences.
Methods
Childbirth domains were derived from literature searches, discussions with experienced midwives and interviews with first-time mothers. A draft version of the Childbirth Experience Questionnaire (CEQ) was pilot tested for face validity among 25 primiparous women. The revised questionnaire was mailed one month postpartum to 1177 primiparous women with a normal pregnancy and spontaneous onset of active labor and 920 returned evaluable questionnaires. Exploratory factor analysis using principal components analysis and promax rotation was performed to identify dimensions of the childbirth experience. Multitrait scaling analysis was performed to test scaling assumptions and reliability of scales. Discriminant validity was assessed by comparing scores from subgroups known to differ in childbirth experiences.
Results
Factor analysis of the 22 item questionnaire yielded four factors accounting for 54% of the variance. The dimensions were labelled Own capacity, Professional support, Perceived safety, and Participation. Multitrait scaling analysis confirmed the fit of the four-dimensional model and scaling success was achieved in all four sub-scales. The questionnaire showed good sensitivity with dimensions discriminating well between groups hypothesized to differ in experience of childbirth.
Conclusion
The CEQ measures important dimensions of the first childbirth experience and may be used to measure different aspects of maternal satisfaction with labour and birth.
doi:10.1186/1471-2393-10-81
PMCID: PMC3008689  PMID: 21143961
10.  The role of hospital midwives in the Netherlands 
Background
Most midwives in the Netherlands work in primary care where they are the lead professionals providing care to women with 'normal' or uncomplicated pregnancies, while some midwives work in hospitals ("clinical midwives"). The actual involvement of midwives in maternity care in hospitals is unknown, because in all statistics births in secondary care are registered as births assisted by gynaecologists. The aim of this study is to gain insight in the involvement of midwives with births in secondary care, under supervision of a gynaecologist. This is done using data from the PRN (The Netherlands Perinatal Registry), a voluntary registration of births in the Netherlands. The PRN covers 97% to 99% of all births taking place under responsibility of a gynaecologist.
Methods
All births registered in secondary care in the period 1998-2007 (1,102,676, on average 61% of all births) were selected. We analyzed trends in socio-demographic, obstetric and organisational characteristics, associated with the involvement of midwives, using frequency tables and uni- and multivariate logistic regression analyses. As main outcome measure the percentage of births in secondary care with a midwife 'catching' the baby was used.
Results
The proportion of births attended by a midwife in secondary care increased from 8.3% in 1998 to 26.06% in 2007, the largest increase involving spontaneous births of a second or later child, on weekdays during day shifts (8.00-20.00 hr) from younger mothers with a gestational age (almost) at term. After 2002, parallel to the growing numbers of midwives working in hospitals, the percentage of instrumental births decreased.
Conclusions
In 2007 more midwives are assisting with more births in secondary care than in 1998. Hospital-based midwives are primarily involved with uncomplicated births of women with relatively low risk demographical and obstetrical characteristics. However, they are still only involved with half of the less complicated births, indicating that there may be room for more midwives in hospitals to care for women with relatively uncomplicated births. Whether an association exists between the growing involvement of midwives and the decreasing percentage of instrumental births needs further investigation.
doi:10.1186/1471-2393-10-80
PMCID: PMC3016258  PMID: 21143883
11.  Breastfeeding attitudes of Finnish parents during pregnancy 
Background
Breastfeeding attitudes are known to influence infant feeding but little information exists on the prenatal breastfeeding attitudes of parents. The purpose of this study was to describe Finnish parents' prenatal breastfeeding attitudes and their relationships with demographic characteristics.
Methods
The electronic Breastfeeding Knowledge, Attitude and Confidence scale was developed and 172 people (123 mothers, 49 fathers) completed the study. The data were analysed using factor analysis and nonparametric methods.
Results
Breastfeeding was regarded as important, but 54% of the respondents wanted both parents to feed the newborn. The mean rank values of breastfeeding attitudes differed significantly when parity, gender, education, age, breastfeeding history and level of breastfeeding knowledge were considered. The respondents who were expecting their first child, were 18-26 years old or had vocational qualifications or moderate breastfeeding knowledge had more negative feelings and were more worried about breastfeeding than respondents who had at least one child, had a higher vocational diploma or academic degree or had high levels of breastfeeding knowledge. Respondents with high levels of breastfeeding knowledge did not appear concerned about equality in feeding.
Conclusions
Both mothers and fathers found breastfeeding important. A father's eagerness to participate in their newborn's life should be included in prenatal breastfeeding counselling and ways in which to support breastfeeding discussed. Relevant information about breastfeeding should focus on the parents who are expecting their first child, those who are young, those with low levels of education or those who have gaps in breastfeeding knowledge, so that fears and negative views can be resolved.
doi:10.1186/1471-2393-10-79
PMCID: PMC3003624  PMID: 21126368
12.  Effects of caesarean section on maternal health in low risk nulliparous women: a prospective matched cohort study in Shanghai, China 
Background
Rates of caesarean section are progressively increasing in many parts of the world. As a result of psychosocial factors there has been an increasing tendency for pregnant women without justifiable medical indications for caesarean section to ask for this procedure in China. A critical examination of this issue in relation to maternal outcomes is important. At present there are no clinical trials to help assess the risks and benefits of caesarean section in low risk women. To fill the gap left by trials, this indication-matched cohort study was carried out to examine prospectively the outcomes of caesarean section on women with no absolute obstetric indication compared with similar women who had vaginal delivery.
Methods
An indication-matched cohort study was undertaken to compare maternal outcomes following caesarean section with those undergoing vaginal delivery, in which the two groups were matched for non-absolute indications. 301 nulliparous women with caesarean section were matched successfully with 301 women who delivered vaginally in the Maternal and Children's Hospitals (MCHs) in Shanghai, China. Logistic regression model or binomial regression model was used to estimate the relative risk (RR) directly. Adjusted RRs were calculated adjusting for propensity score and medical indications.
Results
The incidence of total complications was 2.2 times higher in the caesarean section group during hospitalization post-partum, compared with the vaginal delivery group (RR = 2.2; 95% CI: 1.1-4.4). The risk of haemorrhage from the start of labour until 2 hours post-partum was significantly higher in the caesarean group (RR = 5.6; 95% CI: 1.2-26.9). The risk of chronic abdominal pain was significantly higher for the caesarean section group (RR = 3.6; 95% CI: 1.2-10.9) than for the vaginal delivery group within 12 months post-partum. The two groups had similar incidences of anaemia and complicating infections such as wound complications or urinary tract infection.
Conclusions
In nulliparous women who were at low risk, caesarean section was associated with a higher rate of post-partum morbidity. Those requesting the surgical procedure with no conventional medical indication, should be advised of the potential risks.
doi:10.1186/1471-2393-10-78
PMCID: PMC3014869  PMID: 21122153
13.  Long-Term follow up after intra-Uterine transfusionS; the LOTUS study 
Background
The Leiden University Medical Center (LUMC) is the Dutch national referral centre for pregnancies complicated by haemolytic disease of the fetus and newborn (HDFN) caused by maternal alloimmunization. Yearly, 20-25 affected fetuses with severe anaemia are transfused with intra-uterine blood transfusions (IUT). Mothers of whom their fetus has undergone IUT for HDFN are considered high responders with regard to red blood cell (RBC) antibody formation. Most study groups report high perinatal survival, resulting in a shift in attention towards short- and long-term outcome in surviving children.
Methods/Design
We set up a large long-term observational follow-up study (LOTUS study), in cooperation with the Sanquin Blood Supply Foundation and the LUMC departments of Obstetrics, Neonatology and ImmunoHematology & Bloodtransfusion.
The first part of this study addresses several putative mechanisms associated with blood group alloimmunization in these mothers. The second part of this study determines the incidence of long-term neurodevelopment impairment (NDI) and associated risk factors in children treated with IUT. All women and their life offspring who have been treated with IUT for HDFN in the LUMC from 1987-2008 are invited to participate and after consent, blood or saliva samples are taken. RBC and HLA antigen profile and antibodies are determined by serologic or molecular techniques. Microchimerism populations are tested by real time polymerase chain reaction (RT PCR).
All children are tested for their neurological, cognitive and psychosocial development using standardised tests and questionnaires. The primary outcome is neurodevelopmental impairment (NDI), a composite outcome defined as any of the following: cerebral palsy, cognitive or psychomotor development < 2 standard deviation, bilateral blindness and/or bilateral deafness.
Discussion
The LOTUS study includes the largest cohort of IUT patients ever studied and is the first to investigate post-IUT long-term effects in both mother and child. The results may lead to a change in transfusion policy, in particular future avoidance of certain incompatibilities. Additionally the LOTUS study will provide clinicians and parents better insights in the long-term neurodevelopmental outcome in children with HDFN treated with IUTs, and may improve the quality of antenatal counselling and long-term guidance.
doi:10.1186/1471-2393-10-77
PMCID: PMC3003623  PMID: 21122095
14.  Objectively measured physical activity during pregnancy: a study in obese and overweight women 
Background
Obese and overweight women may benefit from increased physical activity (PA) during pregnancy. There is limited published data describing objectively measured PA in such women.
Methods
A longitudinal observational study of PA intensity, type and duration using objective and subjective measurement methods. Fifty five pregnant women with booking body mass index (BMI) ≥ 25 kg/m2 were recruited from a hospital ultrasound clinic in North East England. 26 (47%) were nulliparous and 22 (40%) were obese (BMI ≥ 30 kg/m2). PA was measured by accelerometry and self report questionnaire at 13 weeks, 26 weeks and/or 36 weeks gestation. Outcome measures were daily duration of light, moderate or vigorous activity assessed by accelerometry; calculated overall PA energy expenditure, (PAEE), and PAEE within four domains of activity based on self report.
Results
At median 13 weeks gestation, women recorded a median 125 mins/day light activity and 35 mins/day moderate or vigorous activity (MVPA). 65% achieved the minimum recommended 30 mins/day MVPA. This proportion was maintained at 26 weeks (62%) and 36 weeks (71%). Women achieving more than 30 mins/day MVPA in the first trimester showed a significant reduction in duration of MVPA by the third trimester (11 mins/day, p = 0.003). Walking, swimming and floor exercises were the most commonly reported recreational activities but their contribution to estimated energy expenditure was small.
Conclusion
Overweight and obese pregnant women can achieve and maintain recommended levels of PA throughout pregnancy. Interventions to promote PA should target changes in habitual activities at work and at home, and in particular walking.
doi:10.1186/1471-2393-10-76
PMCID: PMC3001702  PMID: 21114834
15.  Antenatal counseling in maternal and newborn care: use of job aids to improve health worker performance and maternal understanding in Benin 
Background
Antenatal care provides an important opportunity to improve maternal understanding of care during and after pregnancy. Yet, studies suggest that communication is often insufficient. This research examined the effect of a job aids-focused intervention on quality of counseling and maternal understanding of care for mothers and newborns.
Methods
Counseling job aids were developed to support provider communication to pregnant women. Fourteen health facilities were randomized to control or intervention, where providers were trained to use job aids and provided implementation support. Direct observation of antenatal counseling sessions and patient exit interviews were undertaken to assess quality of counseling and maternal knowledge. Providers were also interviewed regarding their perceptions of the tools. Data were collected before and after the job aids intervention and analyzed using a difference-in-differences analysis to quantify relative changes over time.
Results
Mean percent of recommended messages provided to pregnant women significantly improved in the intervention arm as compared to the control arm in birth preparedness (difference-in-differences [ΔI-C] = +17.9, 95%CI: 6.7,29.1), danger sign recognition (ΔI-C = +26.0, 95%CI: 14.6,37.4), clean delivery (ΔI-C = +21.7, 95%CI: 10.9,32.6), and newborn care (ΔI-C = +26.2, 95%CI: 13.5,38.9). Significant gains were also observed in the mean percent of communication techniques applied (ΔI-C = +28.8, 95%CI: 22.5,35.2) and duration (minutes) of antenatal consultations (ΔI-C = +5.9, 95%CI: 3.0,8.8). No relative increase was found for messages relating to general prenatal care (ΔI-C = +8.2, 95%CI: -2.6,19.1). The proportion of pregnant women with correct knowledge also significantly improved for birth preparedness (ΔI-C = +23.6, 95%CI: 9.8,37.4), danger sign recognition (ΔI-C = +28.7, 95%CI: 14.2,43.2), and clean delivery (ΔI-C = +31.1, 95%CI: 19.4,42.9). There were no significant changes in maternal knowledge of general prenatal (ΔI-C = -6.4, 95%CI: -21.3,8.5) or newborn care (ΔI-C = +12.7, 95%CI: -6.1,31.5). Job aids were positively perceived by providers and pregnant women, although time constraints remained for health workers with other clinical responsibilities.
Conclusions
This study demonstrates that a job aids-focused intervention can be integrated into routine antenatal care with positive outcomes on provider communication and maternal knowledge. Efforts are needed to address time constraints and other communication barriers, including introduction of on-going quality assessment for long-term sustainability.
doi:10.1186/1471-2393-10-75
PMCID: PMC3002891  PMID: 21092183
16.  An option for measuring maternal mortality in developing countries: a survey using community informants 
Background
The maternal mortality ratio (MMR) remains high in most developing countries. Local, recent estimates of MMR are needed to motivate policymakers and evaluate interventions. But, estimating MMR, in the absence of vital registration systems, is difficult. This paper describes an efficient approach using village informant networks to capture maternal death cases (Maternal Deaths from Informants/Maternal Death Follow on Review or MADE-IN/MADE-FOR) developed to address this gap, and examines its validity and efficiency.
Methods
MADE-IN used two village informant networks - heads of neighbourhood units (RTs) and health volunteers (Kaders). Informants were invited to attend separate network meetings - through the village head (for the RT) and through health centre for the kaders. Attached to the letter was a form with written instructions requesting informants list deaths of women of reproductive age (WRA) in the village during the previous two years. At a 'listing meeting' the informants' understanding on the form was checked, informants could correct their forms, and then collectively agreed a consolidated list. MADE-FOR consisted of visits relatives of likely pregnancy related deaths (PRDs) identified from MADE-IN, to confirm the PRD status and gather information about the cause of death. Capture-recapture (CRC) analysis enabled estimation of coverage rates of the two networks, and of total PRDs.
Results
The RT network identified a higher proportion of PRDs than the kaders (estimated 0.85 vs. 0.71), but the latter was easier and cheaper to access. Assigned PRD status amongst identified WRA deaths was more accurate for the kader network, and seemingly for more recent deaths, and for deaths from rural areas. Assuming information on live births from an existing source to calculate the MMR, MADE-IN/MADE-FOR cost only $0.1 (US) per women-year risk of exposure, substantially cheaper than alternatives.
Conclusions
This study shows that reliable local, recent estimates of MMR can be obtained relatively cheaply using two independent informant networks to identify cases. Neither network captured all PRDs, but capture-recapture analysis allowed self-calibration. However, it requires careful avoidance of false-positives, and matching of cases identified by both networks, which was achieved by the home visit.
doi:10.1186/1471-2393-10-74
PMCID: PMC2998457  PMID: 21083883
17.  Current practices in treatment of female genital fistula: a cross sectional study 
Background
Maternal outcomes in most countries of the developed world are good. However, in many developing/resource-poor countries, maternal outcomes are bleaker: Every year, more than 500,000 women die in childbirth, mostly in resource-poor countries. Those who survive often suffer from severe and long-term morbidities. One of the most devastating injuries is obstetric fistula, occurring most often in south Asia and sub-Saharan Africa. Fistula treatment and care are available in many countries across Africa and Asia, but there is a lack of reliable data around clinical factors associated with the success of fistula repair surgery. Most published research has been retrospective. While these studies have provided useful information about the care and treatment of fistula, they are limited by the design. This study was designed to identify practices in care that could lead to the design of prospective and randomized controlled trials.
Methods
Self-administered questionnaires were completed by 40 surgeons known to provide fistula treatment services in Africa and Asia at private and government hospitals. The questionnaire was divided into three parts to address the following issues: prophylactic use of antibiotics before, during, and after fistula surgery; urethral catheter management; and management practices for patients with urinary incontinence following fistula repair.
Results
The results provide a glimpse into current practices in fistula treatment and care across a wide swath of geographic, economic, and organizational considerations. There is consensus in treatment in some areas (routine use of prophylactic antibiotics, limited bed rest until the catheter is removed, nonsurgical treatment for postsurgical incontinence), while there are wide variations in practice in other areas (duration of catheter use, surgical treatments for postsurgical incontinence). These findings are based on a small sample and do not allow for recommending changes in clinical care, but they point to issues for possible clinical trial research that would contribute to more efficient and effective fistula care.
Conclusions
The findings from the survey allowed us to consider clinical practices most influential in the cost, efficacy, and safety of fistula treatment. These considerations led us to formulate recommendations for eight randomized controlled trials on the following subjects: 1) Efficacy/safety of short-term catheterization; 2) efficacy of surgical and nonsurgical therapies for urinary incontinence; 3) technical measures during fistula repair to reduce the incidence of post-surgery incontinence; 4) identification of predictive factors for "incurable fistula"; 5) usefulness of urodynamic studies in the management of urinary incontinence; 6) incidence and significance of multi-drug resistant bacteria in the fistula population; 7) primary management of small, new fistulas by catheter drainage; and 8) antibiotic prophylaxis in fistula repair.
doi:10.1186/1471-2393-10-73
PMCID: PMC2995487  PMID: 21067606
18.  Sleep duration, vital exhaustion and perceived stress among pregnant migraineurs and non-migraineurs 
Background
Migraine has been associated with sleep disorders in men and non-pregnant women, but little is known about sleep complaints among pregnant migraineurs.
Methods
A cohort of 1,334 women was interviewed during early pregnancy. At the time of interview we ascertained participants' migraine diagnosis status and collected information about sleep duration before and during early pregnancy, daytime sleepiness, vital exhaustion and perceived stress during early pregnancy. Multivariable logistic regression procedures were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) of short/long sleep duration, excessive daytime sleepiness, vital exhaustion and elevated perceived stress associated with a history of migraine.
Results
Approximately 19.4% of the cohort (n = 259) reported having a medical diagnosis of migraine prior to the study pregnancy. Compared with women without migraine, the multivariable-adjusted ORs (95% CI) among migraineurs for short sleep duration before and during early pregnancy were 1.51 (1.09-2.09), and 1.57 (1.11-2.23), respectively. The corresponding OR (95% CI) for long sleep duration before and during pregnancy were 1.33 (0.77-2.31) and 1.31 (0.94-1.83), respectively. A modest and statistically insignificant association between migraine history and excessive daytime sleepiness in early pregnancy was noted (OR = 1.46; 95% CI 0.94-2.26). Migraineurs had an increased risk of vital exhaustion (OR = 2.04; 95% CI 1.52-2.76) and elevated perceived stress (OR = 1.57; 95% CI 1.06-2.31). Observed associations were more pronounced among overweight migraineurs.
Conclusions
These data support earlier research documenting increased risks of sleep disorders among migraineurs; and extends the literature to include pregnant women. Prospective studies are needed to more thoroughly explore factors that mediate the apparent migraine-sleep comorbidity among pregnant women.
doi:10.1186/1471-2393-10-72
PMCID: PMC2987887  PMID: 21047418
19.  A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring 
Background
Intrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related to fetal surveillance. Cardiotocographic (CTG) monitoring remains the basis of intrapartum surveillance, but its interpretation by healthcare professionals lacks reproducibility and the technology has not been shown to improve clinically important outcomes. The addition of fetal electrocardiogram analysis has increased the potential to avoid adverse outcomes, but CTG interpretation remains its main weakness. A program for computerised analysis of intrapartum fetal signals, incorporating real-time alerts for healthcare professionals, has recently been developed. There is a need to determine whether this technology can result in better perinatal outcomes.
Methods/design
This is a multicentre randomised clinical trial. Inclusion criteria are: women aged ≥ 16 years, able to provide written informed consent, singleton pregnancies ≥ 36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm) or continuous CTG monitoring as previously performed (control arm). Electrocardiographic monitoring and fetal scalp blood sampling will be available in both arms. The primary outcome measure is the incidence of fetal metabolic acidosis (umbilical artery pH < 7.05, BDecf > 12 mmol/L). Secondary outcome measures are: caesarean section and instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score < 7, neonatal intensive care unit admission, moderate and severe neonatal encephalopathy with a marker of hypoxia, perinatal death, rate of internal monitoring, tracing quality, and signal loss. Analysis will follow an intention to treat principle. Incidences of primary and secondary outcomes will be compared between groups. Assuming a reduction in metabolic acidosis from 2.8% to 1.8%, using a two-sided test with alpha = 0.05, power = 0.80, and 10% loss to follow-up, 8133 women need to be randomised.
Discussion
This study will provide evidence of the impact of intrapartum monitoring with computer analysis and real-time alerts on the incidence of adverse perinatal outcomes, intrapartum interventions and signal quality. (Current controlled trials ISRCTN42314164)
doi:10.1186/1471-2393-10-71
PMCID: PMC2987886  PMID: 21029466
20.  A qualitative study of the experiences and expectations of women receiving in-patient postnatal care in one English maternity unit 
Background
Studies consistently highlight in-patient postnatal care as the area of maternity care women are least satisfied with. As part of a quality improvement study to promote a continuum of care from the birthing room to discharge home from hospital, we explored women's expectations and experiences of current in-patient care.
Methods
For this part of the study, qualitative data from semi-structured interviews were transcribed and analysed using content analyses to identify issues and concepts. Women were recruited from two postnatal wards in one large maternity unit in the South of England, with around 6,000 births a year.
Results
Twenty women, who had a vaginal or caesarean birth, were interviewed on the postnatal ward. Identified themes included; the impact of the ward environment; the impact of the attitude of staff; quality and level of support for breastfeeding; unmet information needs; and women's low expectations of hospital based postnatal care. Findings informed revision to the content and planning of in-patient postnatal care, results of which will be reported elsewhere.
Conclusions
Women's responses highlighted several areas where changes could be implemented. Staff should be aware that how they inter-act with women could make a difference to care as a positive or negative experience. The lack of support and inconsistent advice on breastfeeding highlights that units need to consider how individual staff communicate information to women. Units need to address how and when information on practical aspects of infant care is provided if women and their partners are to feel confident on the woman's transfer home from hospital.
doi:10.1186/1471-2393-10-70
PMCID: PMC2978124  PMID: 20979605
21.  Can i have a second child? dilemmas of mothers of children with pervasive developmental disorder: a qualitative study 
Background
Pervasive developmental disorder (PDD) has an uncertain etiology, no method of treatment, and results in communication deficiencies and other behavioral problems. As the reported recurrence risk is 5%-10% and there are no methods of either prevention or prenatal testing, mothers of PDD children may face unique challenges when contemplating second pregnancies. The purpose of this study was to explore the mothers' lived experiences of second child-related decision-making after the birth of a child with PDD.
Methods
The participants for this study were restricted to mothers living within the greater Tokyo metropolitan area who had given birth to a first child with PDD within the past 18 years. The ten participants were encouraged to describe their experiences of second-child related decision-making after the birth of a child with PDD on the basis of semi-structured interviews. Data analysis was performed by using Interpretive Phenomenological Analysis (IPA), which is concerned with understanding what the participant thinks or believes about the topic under discussion.
Results
We identified two superordinate themes. The first was balancing hopes and fears, in which hope was the potential joy to be gained by the birth of a new child without PDD and fears were characterized as uncertainty of PDD and perception of recurrence risk, burden on later-born children, and negative effects on a child with PDD.
The second superordinate theme was assessing the manageability of the situation, which was affected by factors as diverse as severity of PDD, relationship between mother and father, and social support and acceptance for PDD. Our 10 participants suffered from extreme psychological conflict, and lack of social support and acceptance for PDD created numerous practical difficulties in having second children.
Conclusions
Our participants faced various difficulties when considering second pregnancies after the birth of children with PDD in the Japanese society. As lack of social support and acceptance for PDD also played a large role in second child-related decision-making, creating a social environment that more fully accepts those disabled and providing flexible support systems for families of children with PDD are crucial.
doi:10.1186/1471-2393-10-69
PMCID: PMC2987885  PMID: 20977702
22.  Timing of birth for women with a twin pregnancy at term: a randomised controlled trial 
Background
There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time.
The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications.
Methods/Design
Design: Multicentred randomised trial.
Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy.
Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care.
Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible).
Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity.
Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power).
Discussion
This is a protocol for a randomised trial, the findings of which will contribute information about the optimal time of birth for women with an uncomplicated multiple pregnancy at and beyond 37 weeks gestation.
Clinical Trial Registration
Current Controlled Trials ISRCTN15761056
doi:10.1186/1471-2393-10-68
PMCID: PMC2978123  PMID: 20973989
23.  Use of antenatal care services in Kassala, eastern Sudan 
Background
Antenatal care is named as one of the four pillars initiatives of the Safe Motherhood Initiative. While many of routine antenatal care procedure have little effect on maternal mortality and morbidity, some of these have been ascertained as beneficial. The aim of this study was to investigate coverage of antenatal care and identify factors associated with inadequacy of antenatal care in Kassala, eastern Sudan.
Methods
A cross-sectional community-based study was carried out in Kassala, eastern Sudan during September-October 2009. Household surveys were conducted. Structured questionnaires were used to gather data from women who had been pregnant within the last year, or pregnant more than 14 weeks.
Results
Out of 900 women investigated for antenatal care coverage, 811(90%) women had at least one visit. Only 11% of the investigated women had ≥ four antenatal visits, while 10.0% had not attended at all. Out of 811 women who attended at least one visit, 483 (59.6%), 303 (37.4%) and 25 (3.1%) women attended antenatal care in the first, second and third trimester, respectively. In logistic regression analyses, while maternal age and residence were not associated with inadequacy of antenatal care (<2 visits), high parity (OR = 2.0, CI = 1.1-3.5; P = 0.01) and husband education ≤ secondary level (OR = 2.4, CI = 1.3-4.2; P = 0.002) were associated with inadequacy of antenatal care.
Conclusions
Antenatal care showed a low coverage in Kassala, eastern Sudan. This low coverage was associated with high parity and low husband education.
doi:10.1186/1471-2393-10-67
PMCID: PMC2987884  PMID: 20973972
24.  Spontaneous preterm labor is associated with an increase in the proinflammatory signal transducer TLR4 receptor on maternal blood monocytes 
Background
Localized inflammation and increased expression of TLR4 receptors within the uterus has been implicated in the pathogenesis of preterm labor. It remains unclear whether intrauterine inflammatory responses activate the maternal peripheral circulatory system. Therefore we determined whether increased TLR4 expression is present in the peripheral maternal white blood cells of women with spontaneous preterm labor.
Methods
This is a cross-sectional study of 41 preterm labor cases and 41 non-preterm controls. For each case and control sample, RNA was purified from white blood cells and TLR4 mRNA pool size was evaluated by quantitative PCR. Protein expression levels were determined by flow cytometry. Statistical evaluation using multiple linear regressions was used to determine any significant differences between the cases and controls. The purpose was to determine association prevalence of TLR4 levels and preterm labor.
Results
Adjusted mean TLR4 mRNA levels of 0.788 ± 0.037 (standard error) for preterm labor and 0.348 ± 0.038 for the corresponding pregnant control women were statistically significantly different (P = 0.002). Using the lower 95% confidence interval of the mean expression level in PTL subjects (0.7) as a cutoff value for elevated TLR4 mRNA levels, 25/41 (60.9%) of PTL patients expressed elevated TLR4 mRNA as compared to 0/41 (0%) in control subjects. The TLR4 receptor levels in the granulocyte fraction of white blood cells from preterm labor and pregnant controls were similar. However, TLR4+/CD14+monocytes were 2.3 times more frequent (70% vs. 30%) and TLR4 also had a 2.6-fold higher density (750 vs. 280 molecules per cell) in preterm labor women compared with pregnant controls. There was no difference in the levels of TLR4 in patients at term.
Conclusions
Patients with preterm labor exhibited elevated levels of CD14+ maternal blood monocytes each bearing enhanced expression of TLR4, indicating that the peripheral circulatory system is activated in patients with preterm labor. Elevated leukocyte TLR4 levels may be a useful biomarker associated with preterm labor.
doi:10.1186/1471-2393-10-66
PMCID: PMC2972234  PMID: 20964862
25.  Obstetric near-miss and maternal mortality in maternity university hospital, Damascus, Syria: a retrospective study 
Background
Investigating severe maternal morbidity (near-miss) is a newly recognised tool that identifies women at highest risk of maternal death and helps allocate resources especially in low income countries. This study aims to i. document the frequency and nature of maternal near-miss at hospital level in Damascus, Capital of Syria, ii. evaluate the level of care at maternal life-saving emergency services by comparatively analysing near-misses and maternal mortalities.
Methods
Retrospective facility-based review of cases of near-miss and maternal mortality that took place in the years 2006-2007 at Damascus Maternity University Hospital, Syria. Near-miss cases were defined based on disease-specific criteria (Filippi 2005) including: haemorrhage, hypertensive disorders in pregnancy, dystocia, infection and anaemia. Main outcomes included maternal mortality ratio (MMR), maternal near miss ratio (MNMR), mortality indices and proportion of near-miss cases and mortality cases to hospital admissions.
Results
There were 28 025 deliveries, 15 maternal deaths and 901 near-miss cases. The study showed a MNMR of 32.9/1000 live births, a MMR of 54.8/100 000 live births and a relatively low mortality index of 1.7%. Hypertensive disorders (52%) and haemorrhage (34%) were the top causes of near-misses. Late pregnancy haemorrhage was the leading cause of maternal mortality (60%) while sepsis had the highest mortality index (7.4%). Most cases (93%) were referred in critical conditions from other facilities; namely traditional birth attendants homes (67%), primary (5%) and secondary (10%) healthcare unites and private practices (11%). 26% of near-miss cases were admitted to Intensive Care Unit (ICU).
Conclusion
Near-miss analyses provide valuable information on obstetric care. The study highlights the need to improve antenatal care which would help early identification of high risk pregnancies. It also emphasises the importance of both: developing protocols to prevent/manage post-partum haemorrhage and training health care professionals to manage infrequent but fatal conditions like sepsis. An urgent review of the referral system and the emergency obstetric care in Syria is highly recommended.
doi:10.1186/1471-2393-10-65
PMCID: PMC2973846  PMID: 20959012

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