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1.  Behaviour change in perinatal care practices among rural women exposed to a women's group intervention in Nepal [ISRCTN31137309] 
Background
A randomised controlled trial of participatory women's groups in rural Nepal previously showed reductions in maternal and newborn mortality. In addition to the outcome data we also collected previously unreported information from the subgroup of women who had been pregnant prior to study commencement and conceived during the trial period. To determine the mechanisms via which the intervention worked we here examine the changes in perinatal care of these women. In particular we use the information to study factors affecting positive behaviour change in pregnancy, childbirth and newborn care.
Methods
Women's groups focusing on perinatal care were introduced into 12 of 24 study clusters (average cluster population 7000). A total of 5400 women of reproductive age enrolled in the trial had previously been pregnant and conceived during the trial period.
For each of four outcomes (attendance at antenatal care; use of a boiled blade to cut the cord; appropriate dressing of the cord; not discarding colostrum) each of these women was classified as BETTER, GOOD, BAD or WORSE to describe whether and how she changed her pre-trial practice. Multilevel multinomial models were used to identify women most responsive to intervention.
Results
Among those not initially following good practice, women in intervention areas were significantly more likely to do so later for all four outcomes (OR 1.92 to 3.13). Within intervention clusters, women who attended groups were more likely to show a positive change than non-group members with regard to antenatal care utilisation and not discarding colostrum, but non-group members also benefited.
Conclusion
Women's groups promoted significant behaviour change for perinatal care amongst women not previously following good practice. Positive changes attributable to intervention were not restricted to specific demographic subgroups.
doi:10.1186/1471-2393-6-20
PMCID: PMC1513253  PMID: 16776818
2.  The childbearing health and related service needs of newcomers (CHARSNN) study protocol 
Background
Refugee and asylum-seeking women in Canada may have significant harmful childbearing health outcomes and unmet health and social care needs. The most vulnerable of these women are: those who have left their countries by force (e.g., war, rape or abuse histories), are separated from their families, have limited knowledge of the host country languages, and are visible minorities. Asylum-seekers face additional stresses related to their unknown future status and are marginalized with regards to access to provincial health care systems. The prevalence and severity of health issues in this population is not known nor is the extent of response from social service and health care systems (including variation in provincial service delivery). Understanding the magnitude of health and social concerns of newcomers requires data from a representative sample of childbearing refugee and asylum-seeking women resettling in Canada to permit comparisons to be made with non-refugee immigrant and Canadian-born women. Our research questions are: (1) Do refugee or asylum-seeking women and their infants, experience a greater number or a different distribution of harmful health events during pregnancy, at birth, and during the postpartum period than non-refugee immigrant or Canadian-born women? (2) Are the harmful health events experienced postpartum by asylum-seeking women and their infants, addressed less often (compared to refugees, non-refugee immigrants, and Canadian-born women) by the Canadian health care system as delivered in each of the three major receiving cities for newcomers?
Methods/design
This is a four-year multi-site prospective cohort study (pregnancy to 4 months postpartum). We will seek to recruit 2400 women [200 in each of 4 groups (refugees, asylum-seekers, non-refugee immigrants, and Canadian-born) from 1 of 12 postpartum hospital units across the 3 largest receiving cities for newcomers to Canada – Montreal, Toronto, and Vancouver].
Discussion
Knowledge of the extent of harmful health events occurring to asylum-seeking, refugee, immigrant, and Canadian-born women, and the response of the health care system to those events and group differences, if they exist, will inform immigration and health policy makers as well as providers of services.
doi:10.1186/1471-2393-6-31
PMCID: PMC1797193  PMID: 17190589
3.  Poor glycated haemoglobin control and adverse pregnancy outcomes in type 1 and type 2 diabetes mellitus: Systematic review of observational studies 
Background
Glycaemic control in women with diabetes is critical to satisfactory pregnancy outcome. A systematic review of two randomised trials concluded that there was no clear evidence of benefit from very tight versus tight glycaemic control for pregnant women with diabetes.
Methods
A systematic review of observational studies addressing miscarriage, congenital malformations and perinatal mortality among pregnant women with type 1 and type 2 diabetes was carried out. Literature searches were performed in MEDLINE, EMBASE, CINAHL and Cochrane Library. Observational studies with data on glycated haemoglobin (HbA1c) levels categorised into poor and optimal control (as defined by the study investigators) were selected. Relative risks and odds ratios were calculated for HbA1c and pregnancy outcomes. Adjusted relative risk estimates per 1-percent decrease in HbA1c were calculated for studies which contained information on mean and standard deviations of HbA1c.
Results
The review identified thirteen studies which compared poor versus optimal glycaemic control in relation to maternal, fetal and neonatal outcomes. Twelve of these studies reported the outcome of congenital malformations and showed an increased risk with poor glycaemic control, pooled odds ratio 3.44 (95%CI, 2.30 to 5.15). For four of the twelve studies, it was also possible to calculate a relative risk reduction of congenital malformation for each 1-percent decrease in HbA1c, these varied from 0.39 to 0.59. The risk of miscarriage was reported in four studies and was associated with poor glycaemic control, pooled odds ratio 3.23 (95%CI, 1.64 to 6.36). Increased perinatal mortality was also associated with poor glycaemic control, pooled odds ratio 3.03 (95%CI, 1.87 to 4.92) from four studies.
Conclusion
This analysis quantifies the increase in adverse pregnancy outcomes in women with diabetes who have poor glycaemic control. Relating percentage risk reduction in HbA1c to relative risk of adverse pregnancy events may be useful in motivating women to achieve optimal control prior to conception.
doi:10.1186/1471-2393-6-30
PMCID: PMC1635059  PMID: 17074087
4.  Prediction of pre-eclampsia: a protocol for systematic reviews of test accuracy 
Background
Pre-eclampsia, a syndrome of hypertension and proteinuria, is a major cause of maternal and perinatal morbidity and mortality. Accurate prediction of pre-eclampsia is important, since high risk women could benefit from intensive monitoring and preventive treatment. However, decision making is currently hampered due to lack of precise and up to date comprehensive evidence summaries on estimates of risk of developing pre-eclampsia.
Methods/Design
A series of systematic reviews and meta-analyses will be undertaken to determine, among women in early pregnancy, the accuracy of various tests (history, examinations and investigations) for predicting pre-eclampsia. We will search Medline, Embase, Cochrane Library, MEDION, citation lists of review articles and eligible primary articles and will contact experts in the field. Reviewers working independently will select studies, extract data, and assess study validity according to established criteria. Language restrictions will not be applied. Bivariate meta-analysis of sensitivity and specificity will be considered for tests whose studies allow generation of 2 × 2 tables.
Discussion
The results of the test accuracy reviews will be integrated with results of effectiveness reviews of preventive interventions to assess the impact of test-intervention combinations for prevention of pre-eclampsia.
doi:10.1186/1471-2393-6-29
PMCID: PMC1630696  PMID: 17052339
5.  Human papillomavirus in amniotic fluid 
Background
There is evidence to suggest that human papillomavirus (HPV) can cross the placenta resulting in in-utero transmission. The goal of this study was to determine if HPV can be detected in amniotic fluid from women with intact amniotic membranes.
Methods
Residual amniotic fluid and cultured cell pellets from amniocentesis performed for prenatal diagnosis were used. PGMY09/11 L1 consensus primers and GP5+/GP6+ primers were used in a nested polymerase chain reaction assay for HPV.
Results
There were 146 paired samples from 142 women representing 139 singleton pregnancies, 2 twin pregnancies, and 1 triplet pregnancy. The women were 78% Caucasian, 5% African American, 14% Asian, and 2% Hispanic. The average age was 35.2 years with a range of 23–55 years. All samples were β-globin positive. HPV was not detected in any of the paired samples.
Conclusion
Given the age range, race, and ethnicity of the study population, one would anticipate some evidence of HPV if it could easily cross the placenta, but there was none.
doi:10.1186/1471-2393-6-28
PMCID: PMC1569438  PMID: 16952308
6.  Home delivery and newborn care practices among urban women in western Nepal: a questionnaire survey 
Background
About 98% of newborn deaths occur in developing countries, where most newborns deaths occur at home. In Nepal, approximately, 90% of deliveries take place at home. Information about reasons for delivering at home and newborn care practices in urban areas of Nepal is lacking and such information will be useful for policy makers.
Methods
A cross-sectional survey was carried out in the immunisation clinics of Pokhara city, western Nepal during January and February, 2006. Two trained health workers administered a semi-structured questionnaire to the mothers who had delivered at home.
Results
A total of 240 mothers were interviewed. Planned home deliveries were 140 (58.3%) and 100 (41.7%) were unplanned. Only 6.2% of deliveries had a skilled birth attendant present and 38 (15.8%) mothers gave birth alone. Only 46 (16.2%) women had used a clean home delivery kit and only 92 (38.3%) birth attendants had washed their hands. The umbilical cord was cut after expulsion of placenta in 154 (64.2%) deliveries and cord was cut using a new/boiled blade in 217 (90.4%) deliveries. Mustard oil was applied to the umbilical cord in 53 (22.1%) deliveries. Birth place was heated throughout the delivery in 88 (64.2%) deliveries. Only 100 (45.8%) newborns were wrapped within 10 minutes and 233 (97.1%) were wrapped within 30 minutes. Majority (93.8%) of the newborns were given a bath soon after birth. Mustard oil massage of the newborns was a common practice (144, 60%). Sixteen (10.8%) mothers did not feed colostrum to their babies. Prelacteal feeds were given to 37(15.2%) newborns. Initiation rates of breast-feeding were 57.9% within one hour and 85.4% within 24 hours. Main reasons cited for delivering at home were 'preference' (25.7%), 'ease and convenience' (21.4%) for planned deliveries while 'precipitate labor' (51%), 'lack of transportation' (18%) and 'lack of escort' during labor (11%) were cited for the unplanned ones.
Conclusion
High-risk home delivery and newborn care practices are common in urban population also. In-depth qualitative studies are needed to explore the reasons for delivering at home. Community-based interventions are required to improve the number of families engaging a skilled attendant and hygiene during delivery. The high-risk traditional newborn care practices like delayed wrapping, bathing, mustard oil massage, prelacteal feeding and discarding colostrum need to be addressed by culturally acceptable community-based health education programmes.
doi:10.1186/1471-2393-6-27
PMCID: PMC1560161  PMID: 16928269
7.  The role of urine pregnancy testing in facilitating access to antenatal care and abortion services in South Africa: a cross-sectional study 
Background
Effective confirmation of pregnancy is a basic component of reproductive health services. It is a prerequisite for accessing antenatal care (AnC) if the pregnancy is wanted and abortion services if the pregnancy is unwanted. This study examined the role of urine pregnancy testing in the timing of presentation for pregnancy-care.
Method
A cross-sectional study was conducted among 158 women presenting for antenatal care and 164 women presenting for abortion at public sector clinics in Cape Town, South Africa.
Results
The median gestational age at first presentation was 23 weeks for AnC clients and 13 weeks for abortion clients. Obtaining a urine pregnancy test of one's own accord was associated with a decrease in the gestational age at presentation of 3.6 and 1.4 weeks for antenatal and abortion clients, respectively, independently of all other factors.
Conclusion
Given the proven clinical benefit and public health impact of early presentation for antenatal and abortion services, strategies to decrease gestational age at presentation for pregnancy care should be given priority. 'Fast-track' urine pregnancy testing services should be established in public sector clinics in South Africa.
doi:10.1186/1471-2393-6-26
PMCID: PMC1555610  PMID: 16893459
8.  IMOP: randomised placebo controlled trial of outpatient cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour – clinical trial with analyses of efficacy, cost effectiveness and acceptability 
Background
There is increasing interest in carrying out pre-induction cervical ripening on an outpatient basis. However, there are concerns about the use of prostaglandins, the agents commonly used in hospital settings for this indication, because prostaglandins induce uterine contractions that may lead to fetal hypoxia. Indeed, in a recent study we demonstrated abnormalities in 9% of fetal heart rate tracings performed following prostaglandin induced cervical ripening at term. In contrast, we confirmed in the same study that isosorbide mononitrate (IMN) (administered on an inpatient basis) was both effective in inducing cervical ripening at term, and was associated with no associated fetal heart rate abnormalities.
Methods/design
The aim of this study is to determine whether IMN self administered by women on an outpatient basis improves the process of induction of labour. Specifically, we hypothesise that the use of outpatient IMN will result in a shorter inpatient stay before delivery, decreased costs to the health service and greater maternal satisfaction with ripening and induction of labour, compared with placebo treatment.
In the study described here (the "IMOP" study), women scheduled for induction of labour at term, and who require pre-induction cervical ripening will be randomised to self-administer at home either IMN 40 mg, or a placebo, each vaginally, at 48 hours, 32 hours and 16 hours before scheduled hospital admission.
After admission to hospital, treatment will revert to the usual induction of labour protocol. We will compare the primary outcomes of the elapsed time interval from hospital admission to vaginal delivery, the costs to the health service of induction of labour, and women's experience of induction of labour in the two groups.
Discussion
This trial will provide evidence on the efficacy of outpatient IMN for pre-induction cervical ripening at term. We will study a formulation of IMN which is cheap and widely available. If the treatment is effective, acceptable to women, and cost effective, it could be implemented into obstetric practice worldwide.
Trial registration
The trial has been registered on the International Standard Randomised Controlled Trial Number Register (ISRCTN) and given the registration number ISRTN39772441.
doi:10.1186/1471-2393-6-25
PMCID: PMC1569865  PMID: 16869966
9.  Periodontal disease and spontaneous preterm birth: a case control study 
Background
Several studies have suggested an association between periodontal disease and prematurity but this finding has not been consistently observed.
Methods
Case control study. Cases (n = 50) were women who had delivered after spontaneous preterm labor at <35 weeks gestation. Two groups of controls (n = 101) were recruited: women who were undelivered but at a preterm gestation and women who delivered at term. A standard, clinical, periodontal examination was performed and gingival crevicular fluid was obtained from standardized locations and tested for neutrophil elastase along with the bacterial enzymes gingipain and dipeptidylpeptidase. Data were analyzed with Fisher's exact tests, ANOVA and multivariate logistic regression.
Results
There was no difference in the proportion of sites with significant attachment loss (≥3 mm): Cases-3.2%, Controls-2.2% p = 0.21. The gingival crevicular fluid concentrations of elastase and gingipain were elevated in cases vs. controls 238.8 uU/ul vs. 159.6 uU/ul p = .007 and 2.70 uU/ul vs. 1.56 uU/ul p = .001. On multivariate analysis, the mean log concentration of elastase, but not of gingipain, remained a significant predictor of preterm labor p = .0.015.
Conclusion
We found no evidence that clinical periodontal disease is associated with spontaneous preterm birth. Elevated gingival crevicular fluid levels of elastase were associated with preterm birth but further research is needed before this can be assumed to be a causal relationship.
doi:10.1186/1471-2393-6-24
PMCID: PMC1550250  PMID: 16848912
10.  Maternal serum alpha-fetoprotein levels in fetal hydrocephalus: a retrospective population based study 
Background
Although maternal serum alpha-fetoprotein (MSAFP) is a highly sensitive marker for certain congenital malformations such as open neural tube and ventral wall defects, its usefulness as a screening test for fetal hydrocephalus is uncertain. We wished to determine the distribution of maternal serum alpha-fetoprotein levels associated with fetal hydrocephalus in a population-based screening program in Manitoba, and their potential relationship to additional anomalies.
Methods
Cases of fetal hydrocephalus unrelated to neural tube defects were ascertained from multiple sources and reviewed. Cross-reference with the Manitoba Maternal Serum Screening Program database determined which mothers had undergone maternal serum screening. Mean MSAFP levels in both isolated and complex hydrocephalus were calculated and compared with the general population of screened pregnancies using Independent Samples T-tests.
Results
Mean MSAFP levels in 70 cases of fetal hydrocephalus were significantly higher than those of the general population of screened pregnancies (P = 0.029). This was due to the fact that mean MSAFP levels in those cases with other major anomalies were increased over those of the general population (P = 0.041); cases with hydrocephalus alone showed no significant difference (P = 0.203). Only seven cases (10%) had MSAFP levels ≥ 2.3 multiples of the median, the cut-off used in Manitoba. However, six of these (86%) had additional major and/or minor malformations.
Conclusion
MSAFP screening has low sensitivity for fetal hydrocephalus and is rarely elevated in isolated cases. However, when fetal hydrocephalus is detected, elevated MSAFP levels indicate that the fetus is at significant risk to have additional malformations and further investigations, including chromosome breakage studies, may be indicated.
doi:10.1186/1471-2393-6-23
PMCID: PMC1526755  PMID: 16824231
11.  How much time do health services spend on antenatal care? Implications for the introduction of the focused antenatal care model in Tanzania 
Background
Antenatal care (ANC) is a widely used strategy to improve the health of pregnant women and to encourage skilled care during childbirth. In 2002, the Ministry of Health of the United Republic of Tanzania developed a national adaptation plan based on the new model of the World Health Organisation (WHO). In this study we assess the time health workers currently spent on providing ANC services and compare it to the requirements anticipated for the new ANC model in order to identify the implications of Focused ANC on health care providers' workload.
Methods
Health workers in four dispensaries in Mtwara Urban District, Southern Tanzania, were observed while providing routine ANC. The time used for the overall activity as well as for the different, specific components of 71 ANC service provisions was measured in detail; 28 of these were first visits and 43 revisits. Standard time requirements for the provision of focused ANC were assessed through simulated consultations based on the new guidelines.
Results
The average time health workers currently spend for providing ANC service to a first visit client was found to be 15 minutes; the provision of ANC according to the focused ANC model was assessed to be 46 minutes. For a revisiting client the difference between current practise and the anticipated standard of the new model was 27 minutes (9 vs. 36 min.). The major discrepancy between the two procedures was related to counselling. On average a first visit client was counselled for 1:30 minutes, while counselling in revisiting clients did hardly take place at all. The simulation of focused ANC revealed that proper counselling would take about 15 minutes per visit.
Conclusion
While the introduction of focused ANC has the potential to improve the health of pregnant women and to raise the number of births attended by skilled staff in Tanzania, it may need additional investment in human resources. The generally anticipated saving effect of the new model through the reduction of routine consultations may not materialise because the number of consultations is already low in Tanzania with a median of only 4 visits per pregnancy. Special attention needs to be given to counselling attitudes and skills during the training for Focused ANC as this component is identified as the major difference between old practise and the new model. Our estimated requirement of 46 minutes per first visit consultation matches well with the WHO estimate of 40 minutes.
doi:10.1186/1471-2393-6-22
PMCID: PMC1557863  PMID: 16796749
12.  Herbal medicine use during pregnancy in a group of Australian women 
Background
There are limited data on the extent of women's use of herbal medicines during pregnancy, despite the fact that knowledge of the potential benefits or harms of many of these products is sparse, particularly with respect to their use in pregnancy. We aimed to measure the prevalence of herbal medicine use in a group of pregnant women attending a public tertiary maternity hospital in Melbourne, Australia. Secondary aims were to explore why women took the herbal medicine, where they received advice, what form the supplements took and if they perceived the supplements to be helpful.
Methods
Consecutive pregnant women were approached in the antenatal clinic and the birth centre at around 36–38 weeks gestation. A questionnaire was developed and self-administered in English, as well as being translated into the four most common languages of women attending the hospital: Cantonese, Vietnamese, Turkish and Arabic. Back translation into English was undertaken by different professional translators to verify accuracy of both words and concepts. Data collected included demographic information, model of pregnancy care and herbal supplement use. Descriptive statistics were used initially, with stratified and regression analysis to compare sub-groups.
Results
Of 705 eligible women, 588 (83%) agreed to participate. Of these, 88 (15%) completed the questionnaire in a language other than English. Thirty-six percent of women took at least one herbal supplement during the current pregnancy. The most common supplements taken were raspberry leaf (14%), ginger (12%) and chamomile (11%). Women were more likely to take herbal supplements if they were older, tertiary educated, English speaking, non-smokers and primiparous.
Conclusion
Use of herbal supplements in pregnancy is likely to be relatively high and it is important to ascertain what supplements (if any) women are taking. Pregnancy care providers should be aware of the common herbal supplements used by women, and of the evidence regarding potential benefits or harm.
doi:10.1186/1471-2393-6-21
PMCID: PMC1544352  PMID: 16780602
13.  A qualitative study of an integrated maternity, drugs and social care service for drug-using women 
Background
The care of drug-using pregnant women is a growing health and social care concern in many countries. A specialist clinic was established offering multidisciplinary care and advice to pregnant drug users in and around Aberdeen (UK) in 1997. The majority of women stabilise and reduce their drug use. By determining the needs and views of the women more appropriate services and prevention strategies may be developed. There has been little research conducted in this area and none in Scotland.
Methods
This is a qualitative study that aimed to gain an understanding of the experiences of women drug users, seeking and receiving prenatal care and drug services from a specialist clinic. Twelve women participated in semi-structured one-to-one interviews.
Results
The women preferred the multidisciplinary clinic (one-stop shop) to traditional prenatal care centred within General Practice. The relationships of the clients to the range of Clinic professionals and in hospital were explored as well as attitudes to Clinic care. The study participants attributed success in reducing their drug use to the combination of different aspects of care of the multi-agency clinic, especially the high level prenatal support. It is this arrangement of all aspects of care together that seem to produce better outcomes for mother and child than single care elements delivered separately. Some women reported that their pregnancy encouraged them to rapidly detoxify due to the guilt experienced. The most important aspects of the Clinic care were found to be non-judgemental attitude of staff, consistent staff, high level of support, reliable information and multi-agency integrated care.
Conclusion
There is an impetus for women drug users to change lifestyle during pregnancy. The study highlighted a need for women to have access to reliable information on the effects of drugs on the baby.
Further research is required to determine whether positive outcomes related to clinic attendance in the prenatal period are sustained in the postnatal period. Early referral to a specialist clinic is of benefit to the women, as they reported to receive more appropriate care, especially in relation to their drug use. A greater awareness of needs of the pregnant drug user could help the design of more effective prevention strategies.
doi:10.1186/1471-2393-6-19
PMCID: PMC1501044  PMID: 16772022
14.  Pregnancy outcome following gestational exposure to azithromycin 
Background
Azithromycin is an azalide antibiotic with an extensive range of indications and has become a common treatment option due to its convenient dosing regimen and therapeutic advantages. Human studies addressing gestational use of azithromycin have primarily focused on antibiotic efficacy rather than fetal safety. Our primary objective was to evaluate the possibility of teratogenic risk following gestational exposure to azithromycin.
Methods
There were 3 groups of pregnant women enrolled in our study: 1) women who took azithromycin. 2) women exposed to non-teratogenic antibiotics for similar indications, and 3) women exposed to non-teratogenic agents. They were matched for gestational age at time of call, maternal age, cigarette and alcohol consumption. Rates of major malformations and other endpoints of interest were compared among the three groups.
Results
Pregnancy outcome of 123 women in each group was ascertained. There were no statistically significant differences among the three groups in the rates of major malformations; 3.4% (exposed) versus 2.3% (disease matched) and 3.4% (non teratogen) or any other endpoints that were examined. In the azithromycin group, 88 (71.6%) women took the drug during the first trimester
Conclusion
Results suggest that gestational exposure to azithromycin is not associated with an increase in the rate of major malformations above the baseline of 1–3%. Our data adds to previous research showing that macrolide antibiotics, as a group, are generally safe in pregnancy and provides an evidence-based option for health professionals caring for populations with chlamydia.
doi:10.1186/1471-2393-6-18
PMCID: PMC1481555  PMID: 16734900
15.  Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334] 
Background
Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of breast milk.
Methods/Design
Mothers of infants delivered at less than 31 weeks gestation, who are at least 3 weeks postpartum, and experiencing lactational failure despite non-pharmacological interventions, will be randomized to receive domperidone (10 mg three times daily) or placebo for a 14-day period.
Breast milk samples will be obtained the day prior to beginning treatment and on days 4, 7 and 14. The macronutrient (protein, fat, carbohydrate and energy) and macromineral content (calcium, phosphorus and sodium) will be analyzed and compared between the two groups. Additional outcome measures will include milk volumes, serum prolactin levels (measured on days 0, 4, and 10), daily infant weights and breastfeeding rates at 2 weeks post study completion and at discharge. Forty-four participants will be recruited into the study. Analysis will be carried out using the intention to treat approach.
Discussion
If domperidone causes significant changes to the nutrient content of breast milk, an alteration in feeding practices for preterm infants may need to be made in order to optimize growth, nutrition and neurodevelopment outcomes.
doi:10.1186/1471-2393-6-17
PMCID: PMC1562444  PMID: 16719919
16.  The effects of smoking and hypertensive disorders on fetal growth 
Background
It is well known that smoking and pregnancy induced hypertension (PIH) are associated with decreased fetal growth. It has been reported that in preeclampsia the fetal growth deficit attributable to smoking is higher, which has been contradicted in other studies. We therefore evaluated the effects on fetal growth of early- and late onset PIH and chronic hypertension and how cigarette smoking modify these effects. We also quantified the proportion of small for gestational age (SGA) cases attributable to PIH, chronic hypertension, and smoking.
Methods
Population-based study based on record of 215598 singleton pregnancies from the Medical Birth Registry of Norway.
Results
In severe preeclampsia, mild preeclampsia, transient hypertension, and normotension in term birth, odds ratios (ORs) of SGA in smokers compared with non-smokers were 1.4 (95% confidence interval 0.9, 2.2), 1.6 (1.3, 1.9), 2.3 (1.8, 3.1), and 2.0 (1.9, 2.1), respectively. For preterm births, corresponding ORs were 1.3 (0.9, 2.0), 1.8 (1.1, 3.0), 4.1 (1.9, 9.0), and 1.7 (1.4, 2.0), respectively. The effect of early onset PIH was stronger than that in term births, while the effect of smoking was equal in preterm and term newborns. Only in non-smokers who delivered at term, the rates of SGA significantly increased with the severity of PIH (ORs = 1.3 (1.1, 1.5), 1.8 (1.7, 2.0), and 2.5 (2.2, 3.0) for transient hypertension, mild-, and severe preeclampsia, respectively). The combined effects of smoking and hypertension were generally not synergistic. The effect of smoking was not stronger in women who had chronic hypertension. Nor were the effects of chronic hypertension stronger in smokers. PIH explained 21.9 and 2.5% of preterm and term cases of SGA, respectively, while smoking explained 12% of SGA cases.
Conclusion
The effects of hypertensive disorder and smoking were generally not synergistic, which suggest that they may exert their main actions on separate sites or work through separate mechanisms within or outside the placenta. If smoking were eliminated in pregnant women, the number of SGA cases would be reduced by 12%.
doi:10.1186/1471-2393-6-16
PMCID: PMC1463005  PMID: 16630351
17.  The effect of pre-pregnancy body mass index and gestational weight gain on pregnancy outcomes in urban care settings in Urmia-Iran 
Background
Nutritional status of women has been considered an important prognostic indicator of pregnancy outcomes. Few studies have evaluated patterns of weight gain and pre-pregnancy body mass index in developing regions where malnutrition and poor weight gain as well as maternal obesity have significant influences on the pregnancy outcome. This study aims to show effect of pregnancy body mass index and the corresponding gestational weight gain on the outcome of pregnancy.
Methods
On a prospective cross sectional study, two hundred and seventy women from urban areas of Northwest Iran were recruited for participation during their first eight weeks of pregnancy. Body mass index (BMI) was categorized and gestational weight gain was divided into two groups of normal and abnormal based on recommendations of Institute of Medicine (IOM) published in 1990. Chi square and one way ANOVA were used in the univariate analysis of the association between weight gain and corresponding adverse outcomes including cesarean, preterm labor and low neonatal birth weight. Adjusted odds ratios for adverse outcomes were determined by multiple logistic regression models, while controlling for the following factors: maternal age, parity, and education.
Results
Both pre-pregnancy BMI < 19 and abnormal weight gain during pregnancy were found to be associated with low neonatal birth weight defined as < 2500 g. Abnormal weight gain, during pregnancy was not related to an increased risk of preterm labor or cesarean delivery but it was highly associated with low birth weight (LBW)(P < 0.05).
Conclusion
Low pre-pregnancy BMI is an established risk factor for LBW. Abnormal gestational weight gain may further complicate the pregnancy as an additional risk factor for neonatal LBW. All women, regardless of their pre-pregnancy BMI may be at risk for abnormal weight gain and hence low birth weight. Pre-pregnancy and gestation nutritional assessments remain significant part of all prenatal visits.
doi:10.1186/1471-2393-6-15
PMCID: PMC1459875  PMID: 16626498
18.  Analgesia for labour pain – analysis of the trends and associations in the Grampian region of Scotland between 1986 and 2001 
Background
Although intrapartum analgesia has been in use since Victorian times, there have been few attempts to study its usage from routinely collected data. This population based epidemiological study aimed to analyse retrospective data on the distribution of different types of labour analgesia used by women in the Grampian region of Scotland between 1986 and 2001 in order to examine time trends and associations.
Methods
Data records on all deliveries occurring in the years 1986 to 2001 were extracted from the Aberdeen Maternity and Neonatal Databank.
The rates of the use of epidural, opioid and Entonox or no analgesia for pain relief in labour in each year were calculated.
Maternal, pregnancy, labour and delivery characteristics were compared among the users of three different analgesics by univariate and multivariate analyses.
Results
A total of 81,418 deliveries were analysed. Of these, 12,659 (15.5%) women had epidural, 33,819 (41.5%) had used opioids and 26,974(33.1%) received either Entonox or no analgesia at all. The women who received epidural analgesia were younger, shorter and heavier and had larger babies (OR = 1.05, 95% CI 1.01, 1.08). Three quarters of them were primigravidae and had longer periods of gestation. They were also more likely to have suffered pregnancy related complications (OR = 2.11, 95% CI 1.8, 2.4). Labour was more likely to have been induced (OR = 2.8, 95% CI 2.6, 2.9) and to have lasted longer in this group of women. Women in this group were 5 times more likely to have an instrumental delivery (95% CI 4.9, 5.1) and 7 times more likely to have a Caesarean section (95% CI 5.7, 9.3).
Conclusion
Non epidural analgesia was found to be the most popular choice for pain relief in labour in the Grampian region between 1986 and 2001, although an increase in the uptake of epidural services is starting to occur. The type of labour analgesia used is associated with the epidemiological characteristics of the women's pregnancy, labour and delivery.
doi:10.1186/1471-2393-6-14
PMCID: PMC1463007  PMID: 16623941
19.  Risk factors for pre-term birth in Iraq: a case-control study 
Background
Preterm birth (PTB)is a major clinical problem associated with perinatal mortality and morbidity. The aim of the present study is to identify risk factors associated with PTB in Mosul, Iraq.
Methods
A case-control study was conducted in Mosul, Iraq, from 1st September, 2003 to 28th February, 2004.
Results
A total of 200 cases of PTB and 200 controls of full-term births were screened and enrolled in the study. Forward logistic regression analysis was used in the analysis. Several significant risk associations between PTB and the following risk factors were identified: poor diet (OR = 4.33), heavy manual work (OR = 1.70), caring for domestic animals (OR = 5.06), urinary tract infection (OR = 2.85), anxiety (OR = 2.16), cervical incompetence (OR = 4.74), multiple pregnancies (OR = 7.51), direct trauma to abdomen (OR = 3.76) and abortion (OR = 6.36).
Conclusion
The main determinants of PTB in Iraq were low socio-economic status and factors associated with it, such as heavy manual work and caring for domestic animals, in addition to urinary tract infections and poor obstetric history.
doi:10.1186/1471-2393-6-13
PMCID: PMC1479367  PMID: 16618372
20.  Maternal health study: a prospective cohort study of nulliparous women recruited in early pregnancy 
Background
In the first year after childbirth, 94% of women experience one or more major health problems (urinary incontinence, faecal incontinence, perineal pain, back pain). Difficulties in intimate partner relationships and changes affecting sexual health are also common. The aim of this study is to investigate changes in women's health from early pregnancy until four years after the birth of a first child.
Methods/design
The Maternal Health Study is a longitudinal study designed to fill in some of the gaps in current research evidence regarding women's physical and psychological health and recovery after childbirth. A prospective pregnancy cohort of >1500 nulliparous women has been recruited in early pregnancy at six metropolitan public hospitals in Melbourne, Australia between April 2003 and December 2005. In the first phase of the study participants are being followed up at 30–32 weeks gestation in pregnancy, and at three, six, nine, 12 and 18 months postpartum using a combination of self-administered questionnaires and telephone interviews. Women consenting to extended follow-up (phase 2) will be followed up six and 12 months after any subsequent births and when their first child is four years old. Study instruments incorporate assessment of the frequency and severity of urinary and bowel symptoms, sexual health issues, perineal and abdominal pain, depression and intimate partner violence. Pregnancy and birth outcome data will be obtained by review of hospital case notes.
Discussion
Features of the study which distinguish it from prior research include: the capacity to identify incident cases of morbidity and clustering of health problems; a large enough sample to detect clinically important differences in maternal health outcomes associated with the method of birth; careful exposure measurement involving manual abstraction of data from medical records in order to explore mediating factors and possible causal pathways; and use of a variety of strategies to improve ascertainment of health outcomes.
doi:10.1186/1471-2393-6-12
PMCID: PMC1463006  PMID: 16608507
21.  Absorbing and transferring risk: assessing the impact of a statewide high-risk-pregnancy telemedical program on VLBW maternal transports 
Background
Prior research has shown that resources have an impact on birth outcomes. In this paper we ask how combinations of telemedical and hospital-level resources impact transports of mothers expecting very low birth weight (VLBW) babies in Arkansas.
Methods
Using de-identified birth certificate data from the Arkansas Department of Health, data were gathered on transports of women carrying VLBW babies for two six-month periods: a period just before the start of ANGELS (12/02-05/03), a telemedical outreach program for high-risk pregnancies, and a period after the program had been running for six months (12/03-05/04). For each maternal transport, the following information was recorded: maternal race-ethnicity, maternal age, and the birth weight of the infant. Logistic regression was used to assess the relationship between the predictors (telemedicine, hospital level, maternal characteristics) and the probability of a transport.
Results
Having a telemedical site available increases the probability of a mother carrying a VLBW baby being transported to a level III facility either before or during birth. Having at least a level II nursery also increases the chance of a maternal transport. Where both level II nurseries and telemedical access are available, the odds of VLBW maternal transports are only modestly increased in comparison to the case where neither is present. At the individual level, Hispanic mothers were less likely to be transported than other mothers, and teenaged mothers were more likely to be transported than those 18 and over. A mother's being Black or being over 35 did not have an impact on the odds of being transported to a level III facility.
Conclusion
Combinations of resources have an impact on physician decisions regarding VLBW transports and are interpretable in terms of the capacity to diagnose and absorb risk. We suggest a collegial review of transport patterns and birth outcomes from areas with different levels of resources as a vehicle for moving the entire system of care forward over time. With such an evidence-based review in place, the collegial relations among level III specialists and obstetricians from around the state can, over time, develop workable protocols for when and how level III facilities should be involved.
doi:10.1186/1471-2393-6-11
PMCID: PMC1538626  PMID: 16595016
22.  A randomized cross over trial of tolerability and compliance of a micronutrient supplement with low iron separated from calcium vs high iron combined with calcium in pregnant women [ISRCTN56071145] 
Background
Prenatal micronutrient combinations with high iron content are associated with high rates of gastrointestinal symptoms. This coupled with nausea and vomiting of pregnancy results in women often discontinuing their multivitamins.
A new prescription supplement (PregVit®) that separates iron from calcium in two tablets – morning and evening, has lower elemental iron content (35 mg), but results in similar extent of iron absorption when compared to another supplement containing (60 mg) of elemental iron (Materna®). The objectives of this study were to compare tolerability and compliance with PregVit® vs. a supplement with high iron content (Materna®), in pregnant women.
Methods
Randomized, crossover open labeled study in 135 pregnant women attending outpatient clinics in Ontario and Quebec.
Results
Use of PregVit® was associated with a 30% reduction in constipation rate as compared to Materna®. Both products demonstrated similar compliance rates.
Compliance of Materna® was negatively associated with the severity of nausea and vomiting of pregnancy. No such correlation was found for PregVvit®.
Conclusion
PregVit®, a supplement with lower iron content (35 mg), has significantly decreased constipation rates as compared to 60 mg iron- Materna and has similar compliance rates. High iron content in multivitamin supplements is associated with adverse effects in pregnancy.
doi:10.1186/1471-2393-6-10
PMCID: PMC1481554  PMID: 16595003
23.  Protocol for the immediate delivery versus expectant care of women with preterm prelabour rupture of the membranes close to term (PPROMT) Trial [ISRCTN44485060] 
Background
Preterm prelabour rupture of membranes (PPROM) complicates up to 2% of all pregnancies and is the cause of 40% of all preterm births. The optimal management of women with PPROM prior to 37 weeks, is not known. Furthermore, diversity in current clinical practice suggests uncertainty about the appropriate clinical management.
There are two options for managing PPROM, expectant management (a wait and see approach) or early planned birth. Infection is the main risk for women in which management is expectant. This risk need to be balanced against the risk of iatrogenic prematurity if early delivery is planned. The different treatment options may also have different health care costs. Expectant management results in prolonged antenatal hospitalisation while planned early delivery may necessitate intensive care of the neonate for problems associated with prematurity.
Methods/Design
We aim to evaluate the effectiveness of early planned birth compared with expectant management for women with PPROM between 34 weeks and 366 weeks gestation, in a randomised controlled trial. A secondary aim is a cost analysis to establish the economic impact of the two treatment options and establish the treatment preferences of women with PPROM close to term.
The early planned birth group will be delivered within 24 hours according to local management protocols. In the expectant management group birth will occur after spontaneous labour, at term or when the attending clinician feels that birth is indicated according to usual care. Approximately 1812 women with PPROM at 34–366 weeks gestation will be recruited for the trial.
The primary outcome of the study is neonatal sepsis. Secondary infant outcomes include respiratory distress, perinatal mortality, neonatal intensive care unit admission, assisted ventilation and early infant development. Secondary maternal outcomes include chorioamnionitis, postpartum infection treated with antibiotics, antepartum haemorrhage, induction of labour, mode of delivery, maternal satisfaction with care, duration of hospitalisation, and maternal wellbeing at four months postpartum.
Discussion
This trial will provide evidence on the optimal care for women with PPROM close to term (34–37 weeks gestation). Consideration of both the clinical and economic sequelae of the management of PPROM will enable informed decision making and guideline development.
doi:10.1186/1471-2393-6-9
PMCID: PMC1464097  PMID: 16556323
24.  Effects of high volume saline enemas vs no enema during labour – The N-Ma Randomised Controlled Trial [ISRCTN43153145] 
Background
Enemas are used during labour in obstetric settings with the belief that they reduce puerperal and neonatal infections, shorten labour duration, and make delivery cleaner for attending personnel. However, a systematic review of the literature found insufficient evidence to support the use of enemas. The objective of this RCT was to address an identified knowledge gap by determining the effect of routine enemas used during the first stage of labour on puerperal and neonatal infection rates.
Methods
Design: RCT (randomised controlled trial; randomized clinical trial).
Outcomes: Clinical diagnosis of maternal or neonatal infections, labour duration, delivery types, episiotomy rates, and prescription of antibiotics
Setting: Tertiary care referral hospital at the Javeriana University (Bogotá, Colombia) that attended 3170 births during study period with a caesarean section rate of 26%.
Participants: 443 women admitted for delivery to the obstetrics service (February 1997 to February 1998) and followed for a month after delivery. Inclusion criteria were women with: low risk pregnancy and expected to remain in Bogotá during follow up; gestational age ≥ 36 weeks; no pelvic or systemic bacterial infection; intact membranes; cervix dilatation ≤7 cm.
Intervention: 1 litre saline enema, versus no enema, allocated following a block random allocation sequence and using sealed opaque envelopes.
Results
Allocation provided balanced groups and 86% of the participants were followed up for one month. The overall infection rate for newborns was 21%, and 18% for women. We found no significant differences in puerperal or neonatal infection rates (Puerperal infection: 41/190 [22%] with enema v 26/182 [14%] without enema; RR 0.66 CI 95%: 0.43 to 1.03; neonatal infection 38/191 [20%] with enema v 40/179 [22%] without enema; RR 1.12, 95% CI 95% 0.76 to 1.66), and median labour time was similar between groups (515 min. with enema v 585 min. without enema; P = 0.24). Enemas didn't significantly change episiorraphy dehiscence rates (21/182 [12%] with enema v 32/190 [17%] without enema; P = 0.30).
Conclusion
This RCT found no evidence to support routine use of enemas during labour. Although these results cannot rule out a small clinical effect, it seems unlikely that enemas will improve maternal and neonatal outcomes and provide an overall benefit.
doi:10.1186/1471-2393-6-8
PMCID: PMC1468428  PMID: 16545140
25.  Endothelial nitric oxide synthase gene polymorphism (Glu298Asp) and development of pre-eclampsia: a case-control study and a meta-analysis 
Background
Pre-eclampsia is thought to have an important genetic component. Recently, pre-eclampsia has been associated in some studies with carriage of a common eNOS gene Glu298Asp polymorphism, a variant that leads to the replacement of glutamic acid by aspartic acid at codon 298.
Method
Healthy women with singleton pregnancies were recruited from 7 district general hospitals in London, UK. Women at high risk of pre-eclampsia were screened by uterine artery Doppler velocimetry at 22–24 weeks of gestation and maternal blood was obtained to genotype the eNOS Glu298Asp polymorphism. Odds ratios (OR) and 95%CI, using logistic regression methods, were obtained to evaluate the association between the Glu298Asp polymorphism and pre-eclampsia. A meta-analysis was then undertaken of all published studies up to November 2005 examining the association of eNOS Glu298Asp genotype and pre-eclampsia.
Results
89 women with pre-eclampsia and 349 controls were included in the new study. The Glu298Asp polymorphism in a recessive model was not significantly associated with pre-eclampsia (adjusted-OR: 0.83 [95%CI: 0.30–2.25]; p = 0.7). In the meta-analysis, under a recessive genetic model (1129 cases & 2384 controls) women homozygous for the Asp298 allele were not at significantly increased risk of pre-eclampsia (OR: 1.28 [95%CI: 0.76–2.16]; p = 0.34). A dominant model (1334 cases & 2894 controls) was associated with no increase of risk of pre-eclampsia for women carriers of the Asp298 allele (OR: 1.12 [95%CI: 0.84–1.49]; p = 0.42).
Conclusion
From the data currently available, the eNOS Glu298Asp polymorphism is not associated with a significant increased risk of pre-eclampsia. However, published studies have been underpowered, much larger studies are needed to confirm or refute a realistic genotypic risk of disease, but which might contribute to many cases of pre-eclampsia in the population.
doi:10.1186/1471-2393-6-7
PMCID: PMC1431561  PMID: 16542455

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