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1.  The DiAMOND trial protocol: a randomised controlled trial of two decision aids for mode of delivery among women with a previous caesarean section [ISRCTN84367722] 
Background
Caesarean section (CS) has become an increasingly common method of delivery worldwide, rising in the UK from 9% of deliveries in 1980 to over 21% 2001. This increase, and the question of whether CS should be available to women on request, has been the subject of considerable debate, and national reports and guidelines have specifically highlighted the importance of patient choice in the decision making process. For women who have already experienced CS, the UK National Institute of Clinical Excellence recommends that the decision should consider maternal preferences and priorities in addition to general discussion of the overall risks and benefits of CS. Decision aids for many different medical treatment and screening decisions have been developed and evaluated, but there is relatively little evidence for the use of decision aids for choice of mode of delivery among women with a previous CS. The aim of the study is to evaluate two interventions to assist decision making about mode of delivery among pregnant women with one previous CS.
Methods/design
Women with one previous CS are recruited to the trial during their booking visit at approximately 12–20 weeks' gestation in participating maternity units in Bristol, Weston and Dundee. Using central randomisation, women are allocated to one of three arms: information programme and website; decision analysis; usual care. Both interventions are computer-based, and are designed to provide women with detailed information about the potential outcomes for both mother and baby of planned vaginal delivery, planned CS and emergency CS. The decision analysis intervention additionally provides a recommended 'preferred option' based on maximised expected utility. There are two primary outcomes (decisional conflict and actual mode of delivery), and five secondary outcomes (anxiety, knowledge, perceptions of shared decision making; satisfaction with decision making process, proportion of women attempting vaginal delivery). Primary follow up for the questionnaire measures is at 36–37 weeks' gestation, and a total of 660 women will be recruited to the study. The primary intention-to-treat analyses will comprise three pair-wise comparisons between decision analysis, information and usual care groups, for each of the two primary outcomes. A qualitative study will investigate women's experiences of the decision making in more depth, and an economic evaluation from the perspective of the NHS will be conducted.
Discussion
Provision of information to women facing this decision appears variable. The DiAMOND study aims to inform best practice in this area by evaluating the effectiveness of two interventions designed to aid decision making.
doi:10.1186/1471-2393-4-25
PMCID: PMC539355  PMID: 15588324
2.  Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598] 
Background
There is now good evidence about the management options for pregnant women with a breech presentation (buttocks or feet rather than head-first) at term; external cephalic version (ECV) – the turning of a breech baby to a head-down position and/or planned caesarean section (CS). Each of these options has benefits and risks and the relative importance of these vary for each woman, subject to her personal values and preferences, a situation where a decision aid may be helpful.
Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values.
The ECV decision aid was developed using the Ottawa Decision Support Framework, including a systematic review of the evidence about the benefits and risks of the options for breech pregnancy. It comprises an audiotape with a supplementary booklet and worksheet, a format that can be taken home and discussed with a partner. This project aims to evaluate the ECV decision aid for women with a breech presenting baby in late pregnancy.
Study design
We aim to evaluate the effectiveness of the decision aid compared with usual care in a randomised controlled trial in maternity hospitals that offer ECV. The study group will receive the decision aid in addition to usual care and the control group will receive standard information on management options for breech presentation from their usual pregnancy care provider. Approximately 184 women with a single breech-presenting baby at greater than 34 weeks gestation and who are clinically eligible for ECV will be recruited for the trial.
The primary outcomes of the study are knowledge, decisional conflict, anxiety and satisfaction with decision-making that will be assessed using self-administered questionnaires. The decision aid is not intended to influence either the uptake of either ECV or planned CS, however we will monitor health service utilisation rates and maternal and perinatal outcomes.
doi:10.1186/1471-2393-4-26
PMCID: PMC545961  PMID: 15606926
3.  Potential of essential fatty acid deficiency with extremely low fat diet in lipoprotein lipase deficiency during pregnancy: A case report 
Background
Pregnancy in patients with lipoprotein lipase deficiency is associated with high risk of maternal pancreatitis and fetal death. A very low fat diet (< 10% of calories) is the primary treatment modality for the prevention of acute pancreatitis, a rare but potentially serious complication of severe hypertriglyceridemia. Since pregnancy can exacerbate hypertriglyceridemia in the genetic absence of lipoprotein lipase, a further reduction of dietary fat intake to < 1–2% of total caloric intake may be required during the pregnancy, along with the administration of a fibrate. It is uncertain if essential fatty acid deficiency will develop in the mother and fetus with this extremely low fat diet, or whether fibrates will cross the placenta and concentrate in the fetus.
Case presentation
A 23 year-old gravida 1 woman with primary lipoprotein lipase deficiency was seen at 7 weeks of gestation in the Lipid Clinic for management of severe hypertriglyceridemia that had worsened with pregnancy. While on her habitual fat intake of 10% of total calories, her pregnancy resulted in an exacerbation of the hypertriglyceridemia, which prompted further restriction of fat intake to < 2% of total calories, as well as administration of gemfibrozil at a lower than average dose. The level of gemfibrozil, as the active metabolite, in the venous and arterial fetal cord blood was within the expected therapeutic range for adults. The clinical signs and a biomarker of essential fatty acid deficiency, namely the ratio of 20:3 [n-9] to 20:4 [n-6] fatty acids, were closely monitored throughout her pregnancy. Despite her extremely low fat diet, the levels of essential fatty acids measured in the mother and in the fetal blood immediately postpartum were normal. Normal essential fatty acid levels may have been achieved by the topical application of sunflower oil.
Conclusions
An extremely low fat diet in combination with topical sunflower oil and gemfibrozil administration was safely implemented in pregnancy associated with the severe hypertriglyceridemia of lipoprotein lipase deficiency.
doi:10.1186/1471-2393-4-27
PMCID: PMC544881  PMID: 15610556
4.  Protocol for a randomised controlled trial of a decision aid for the management of pain in labour and childbirth [ISRCTN52287533] 
Background
Women report fear of pain in childbirth and often lack complete information on analgesic options prior to labour. Preferences for pain relief should be discussed before labour begins. A woman's antepartum decision to use pain relief is likely influenced by her cultural background, friends, family, the media, literature and her antenatal caregivers. Pregnant women report that information about analgesia was most commonly derived from hearsay and least commonly from health professionals. Decision aids are emerging as a promising tool to assist practitioners and their patients in evidence-based decision making.
Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values.
Methods/design
We aim to evaluate the effectiveness of a Pain Relief for Labour decision aid, with and without an audio-component, compared to a pamphlet in a three-arm randomised controlled trial. Approximately 600 women expecting their first baby and planning a vaginal birth will be recruited for the trial.
The primary outcomes of the study are decisional conflict (uncertainty about a course of action), knowledge, anxiety and satisfaction with decision-making and will be assessed using self-administered questionnaires. The decision aid is not intended to influence the type of analgesia used during labour, however we will monitor health service utilisation rates and maternal and perinatal outcomes. This study is funded by a competitive peer-reviewed grant from the Australian National Health and Medical Research Council (No. 253635).
Discussion
The Pain Relief for Labour decision aid was developed using the Ottawa Decision Support Framework and systematic reviews of the evidence about the benefits and risks of the non-pharmacological and pharmacological methods of pain relief for labour. It comprises a workbook and worksheet and has been developed in two forms – with and without an audio-component (compact disc). The format allows women to take the decision aid home and discuss it with their partner.
doi:10.1186/1471-2393-4-24
PMCID: PMC539301  PMID: 15588303
5.  Successful obstetrical management of 110-day intertwin delivery interval without cerclage: counseling and conservative management approach to extreme asynchronous twin birth 
Background
This report describes a patient counseling approach and non-surgical management of a dichorionic-diamniotic twin pregnancy where delivery of the second twin followed the delivery of the first by 110 days.
Case presentation
An early transvaginal sonogram at 19 1/2 weeks suggested cervical dilation with protruding amniotic membranes. Tocolytic and antibiotic therapy was initiated; no cerclage was placed. Spontaneous rupture of membranes and cord prolapse occurred 48 h later, resulting in delivery of a stillborn female infant. Conservative management was offered after counseling for possible risks associated with maternal sepsis, need for extended hospitalization, potential for hysterectomy and death. The cervix appeared closed after delivery and the umbilical cord was ligated, with subsequent spontaneous cord retraction in utero. Reassuring fetal status was observed for twin B without evidence of contractions or chorioamnionitis. A viable male infant (2894 g) was delivered vaginally at 35 1/2 weeks.
Conclusions
This report outlines a counseling approach useful for patients with premature delivery of one twin, and presents application of conservative obstetrical management principles for the aftercoming twin even when delivery interval is extreme.
doi:10.1186/1471-2393-4-23
PMCID: PMC539248  PMID: 15581427
6.  Reexamining the effects of gestational age, fetal growth, and maternal smoking on neonatal mortality 
Background
Low birth weight (<2,500 g) is a strong predictor of infant mortality. Yet low birth weight, in isolation, is uninformative since it is comprised of two intertwined components: preterm delivery and reduced fetal growth. Through nonparametric logistic regression models, we examine the effects of gestational age, fetal growth, and maternal smoking on neonatal mortality.
Methods
We derived data on over 10 million singleton live births delivered at ≥ 24 weeks from the 1998–2000 U.S. natality data files. Nonparametric multivariable logistic regression based on generalized additive models was used to examine neonatal mortality (deaths within the first 28 days) in relation to fetal growth (gestational age-specific standardized birth weight), gestational age, and number of cigarettes smoked per day. All analyses were further adjusted for the confounding effects due to maternal age and gravidity.
Results
The relationship between standardized birth weight and neonatal mortality is nonlinear; mortality is high at low z-score birth weights, drops precipitously with increasing z-score birth weight, and begins to flatten for heavier infants. Gestational age is also strongly associated with mortality, with patterns similar to those of z-score birth weight. Although the direct effect of smoking on neonatal mortality is weak, its effects (on mortality) appear to be largely mediated through reduced fetal growth and, to a lesser extent, through shortened gestation. In fact, the association between smoking and reduced fetal growth gets stronger as pregnancies approach term.
Conclusions
Our study provides important insights regarding the combined effects of fetal growth, gestational age, and smoking on neonatal mortality. The findings suggest that the effect of maternal smoking on neonatal mortality is largely mediated through reduced fetal growth.
doi:10.1186/1471-2393-4-22
PMCID: PMC535930  PMID: 15574192
7.  Missing paternal demographics: A novel indicator for identifying high risk population of adverse pregnancy outcomes 
Background
One of every 6 United Status birth certificates contains no information on fathers. There might be important differences in the pregnancy outcomes between mothers with versus those without partner information. The object of this study was to assess whether and to what extent outcomes in pregnant women who did not have partner information differ from those who had.
Methods
We carried out a population-based retrospective cohort study based on the registry data in the United States for the period of 1995–1997, which was a matched multiple birth file (only twins were included in the current analysis). We divided the study subjects into three groups according to the availability of partner information: available, partly missing, and totally missing. We compared the distribution of maternal characteristics, maternal morbidity, labor and delivery complications, obstetric interventions, preterm birth, fetal growth restriction, low birth weight, congenital anomalies, fetal death, neonatal death, post-neonatal death, and neonatal morbidity among three study groups.
Results
There were 304466 twins included in our study. Mothers whose partner's information was partly missing and (especially) totally missing tended to be younger, of black race, unmarried, with less education, smoking cigarette during pregnancy, and with inadequate prenatal care. The rates of preterm birth, fetal growth restriction, low birth weight, Apgar score <7, fetal mortality, neonatal mortality, and post-neonatal mortality were significantly increased in mothers whose partner's information was partly or (especially) totally missing.
Conclusions
Mothers whose partner's information was partly and (especially) totally missing are at higher risk of adverse pregnant outcomes, and clinicians and public health workers should be alerted to this important social factor.
doi:10.1186/1471-2393-4-21
PMCID: PMC535341  PMID: 15541183
8.  A comprehensive evaluation of food fortification with folic acid for the primary prevention of neural tube defects 
Background
Periconceptional use of vitamin supplements containing folic acid reduces the risk of a neural tube defect (NTD). In November 1998, food fortification with folic acid was mandated in Canada, as a public health strategy to increase the folic acid intake of all women of childbearing age. We undertook a comprehensive population based study in Newfoundland to assess the benefits and possible adverse effects of this intervention.
Methods
This study was carried out in women aged 19–44 years and in seniors from November 1997 to March 1998, and from November 2000 to March 2001. The evaluation was comprised of four components: I) Determination of rates of NTDs; II) Dietary assessment; III) Blood analysis; IV) Assessment of knowledge and use of folic acid supplements.
Results
The annual rates of NTDs in Newfoundland varied greatly between 1976 and 1997, with a mean rate of 3.40 per 1,000 births. There was no significant change in the average rates between 1991–93 and 1994–97 (relative risk [RR] 1.01, 95% confidence interval [CI] 0.76–1.34). The rates of NTDs fell by 78% (95% CI 65%–86%) after the implementation of folic acid fortification, from an average of 4.36 per 1,000 births during 1991–1997 to 0.96 per 1,000 births during 1998–2001 (RR 0.22, 95% CI 0.14–0.35). The average dietary intake of folic acid due to fortification was 70 μg/day in women aged 19–44 years and 74 μg/day in seniors. There were significant increases in serum and RBC folate levels for women and seniors after mandatory fortification. Among seniors, there were no significant changes in indices typical of vitamin B12 deficiencies, and no evidence of improved folate status masking haematological manifestations of vitamin B12 deficiency. The proportion of women aged 19–44 years taking a vitamin supplement containing folic acid increased from 17% to 28%.
Conclusions
Based on these findings, mandatory food fortification in Canada should continue at the current levels. Public education regarding folic acid supplement use by women of childbearing age should also continue.
doi:10.1186/1471-2393-4-20
PMCID: PMC524178  PMID: 15450123
9.  A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389] 
Background
A small, non-blinded, RCT (randomised controlled trial) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus (S. aureus)- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size.
Methods
Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin) could prevent mastitis in lactating women with S. aureus-colonized cracked nipples. We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples.
Results
We spent over twelve months submitting applications to five hospital ethics committees and seven funding bodies, before commencing the trial. Recruitment to the trial was very slow and only ten women were randomized to the trial after twelve months, and therefore the trial was stopped early.
Conclusions
In retrospect we should have conducted a feasibility study, which would have revealed the low number of women in these Melbourne hospitals (maternity wards and breastfeeding clinics) with damaged nipples. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested.
doi:10.1186/1471-2393-4-19
PMCID: PMC521079  PMID: 15369597
10.  Malaria and anemia prevention in pregnant women of rural Burkina Faso 
Background
Pregnant women are a major risk group for malaria in endemic areas. Only little information exists on the compliance of pregnant women with malaria and anaemia preventive drug regimens in the rural areas of sub-Saharan Africa (SSA). In this study, we collected information on malaria and anaemia prevention behaviour in pregnant women of rural Burkina Faso.
Methods
Cross-sectional qualitative and quantitative survey among 225 women of eight villages in rural northwestern Burkina Faso. Four of the villages had a health centre offering antenatal care (ANC) services while the other four were more than five kilometers away from a health centre.
Results
Overall ANC coverage (at least one visit) was 71% (95% in health centre villages vs 50% in remote villages). Malaria and anaemia were considered as the biggest problems during pregnancy in this community. ANC using women were quite satisfied with the quality of services, and compliance with malaria and anaemia prevention regimens (chloroquine and iron/folic acid) was high in this population. Knowledge on the benefit of bed nets and good nutrition was less prominent. Distance, lack of money and ignorance were the main reasons for women to not attend ANC services.
Conclusions
There is an urgent need to improve access of rural SSA women to ANC services, either through increasing the number of rural health centres or establishing functioning outreach services. Moreover, alternative malaria and anaemia prevention programmes such as intermittent preventive treatment with effective antimalarials and the distribution of insecticide-treated bed nets need to become implemented on a large scale.
doi:10.1186/1471-2393-4-18
PMCID: PMC516443  PMID: 15333138
11.  The effect of hypertensive disorders in pregnancy on small for gestational age and stillbirth: a population based study 
Background
Hypertensive disorders in pregnancy are leading causes of maternal, fetal and neonatal morbidity and mortality worldwide. However, studies attempting to quantify the effect of hypertension on adverse perinatal outcomes have been mostly conducted in tertiary centres. This population-based study explored the frequency of hypertensive disorders in pregnancy and the associated increase in small for gestational age (SGA) and stillbirth.
Methods
We used information on all pregnant women and births, in the Canadian province of Nova Scotia, between 1988 and 2000. Pregnancies were excluded if delivery occurred < 20 weeks, if birthweight was < 500 grams, if there was a high-order multiple pregnancy (greater than twin gestation), or a major fetal anomaly.
Results
The study population included 135,466 pregnancies. Of these, 7.7% had mild pregnancy-induced hypertension (PIH), 1.3% had severe PIH, 0.2% had HELLP (hemolysis, elevated liver enzymes, low platelets), 0.02% had eclampsia, 0.6% had chronic hypertension, and 0.4% had chronic hypertension with superimposed PIH. Women with any hypertension in pregnancy were 1.6 (95% CI 1.5–1.6) times more likely to have a live birth with SGA and 1.4 (95% CI 1.1–1.8) times more likely to have a stillbirth as compared with normotensive women. Adjusted analyses showed that women with gestational hypertension without proteinuria (mild PIH) and with proteinuria (severe PIH, HELLP, or eclampsia) were more likely to have infants with SGA (RR 1.5, 95% CI 1.4–1.6 and RR 3.2, 95% CI 2.8–3.6, respectively). Women with pre-existing hypertension were also more likely to give birth to an infant with SGA (RR 2.5, 95% CI 2.2–3.0) or to have a stillbirth (RR 3.2, 95% CI 1.9–5.4).
Conclusions
This large, population-based study confirms and quantifies the magnitude of the excess risk of small for gestational age and stillbirth among births to women with hypertensive disease in pregnancy.
doi:10.1186/1471-2393-4-17
PMCID: PMC515178  PMID: 15298717
12.  Misoprostol for treating postpartum haemorrhage: a randomized controlled trial [ISRCTN72263357] 
Background
Postpartum haemorrhage remains an important cause of maternal death despite treatment with conventional therapy. Uncontrolled studies and one randomised comparison with conventional oxytocics have reported dramatic effects with high-dose misoprostol, usually given rectally, for treatment of postpartum haemorrhage, but this has not been evaluated in a placebo-controlled trial.
Methods
The study was conducted at East London Hospital Complex, Tembisa and Chris Hani Baragwanath Hospitals, South Africa. Routine active management of the third stage of labour was practised. Women with more than usual postpartum bleeding thought to be related to inadequate uterine contraction were invited to participate, and to sign informed consent. All routine treatment was given from a special 'Postpartum Haemorrhage Trolley'. In addition, participants who consented were enrolled by drawing the next in a series of randomised treatment packs containing either misoprostol 5 × 200 μg or similar placebo, which were given 1 orally, 2 sublingually and 2 rectally.
Results
With misoprostol there was a trend to reduced blood loss ≥500 ml in 1 hour after enrolment measured in a flat plastic 'fracture bedpan', the primary outcome (6/117 vs 11/120, relative risk 0.56; 95% confidence interval 0.21 to 1.46). There was no difference in mean blood loss or haemoglobin level on day 1 after birth < 6 g/dl or blood transfusion. Side-effects were increased, namely shivering (63/116 vs 30/118; 2.14, 1.50 to 3.04) and pyrexia > 38.5°C (11/114 vs 2/118; 5.69, 1.29 to 25). In the misoprostol group 3 women underwent hysterectomy of whom 1 died, and there were 2 further maternal deaths.
Conclusions
Because of a lower than expected incidence of the primary outcome in the placebo group, the study was underpowered. We could not confirm the dramatic effect of misoprostol reported in several unblinded studies, but the results do not exclude a clinically important effect. Larger studies are needed to assess substantive outcomes and risks before misoprostol enters routine use.
doi:10.1186/1471-2393-4-16
PMCID: PMC514549  PMID: 15298718
13.  'Perinatal outcome in preterm premature rupture of membranes with Amniotic fluid index < 5 (AFI < 5) 
Background
Our purpose was to determine whether AFI<5 cm after preterm premature rupture of the membranes (PPROM) is associated with an increased risk of perinatal morbidity.
Methods
We performed a prospective cohort study of 95 singleton pregnancies complicated by preterm premature rupture of the membranes (PPROM) with delivery between 26 and 34 weeks gestation.
Patients were categorized in two groups on the basis of amniotic fluid index<5, (AFI<5 cm)(n = 26) or AFI ≥ 5 cm (n = 69). Categorical data were tested for significance with the χ2 and Fisher exact tests. Continuous data were evaluated for normal distribution and tested for significance with the student t test.
All 2-sided p values < 0.05 were considered significant.
Results
Both groups were similar with respect to selected demographics, gestational age at rupture of the membranes, gestational age at the delivery, birth weight. Both groups were similar with respect to selected variable, latency until delivery, early onset neonatal sepsis, RDS and neonatal death. Patients with AFI<5 cm demonstrated greater frequency of C/S delivery for non reassuring fetal tests (23%vs 2.8%) (p = 0.001). Our study demonstrated that patients in group I had a significant increase in the frequency of clinical chorioamnionitis (P < 0/001). Post partum infections were not seen in 2 groups.
Conclusions
An AFI<5 cm after PPROM between 26 and 34 weeks gestation is associated with an increased risk of maternal infections and frequency of C/S.
doi:10.1186/1471-2393-4-15
PMCID: PMC512289  PMID: 15291965
PROM; chorioamnionitis; neonatal sepsis; AFI<5
14.  Myomectomy at time of cesarean delivery: a retrospective cohort study 
Background
Myomectomy at time of cesarean delivery is traditionally discouraged because of the risk of hemorrhage. A retrospective cohort study was performed to determine whether myomectomy at time of cesarean delivery leads to an increased incidence of intrapartum and short-term postpartum complications.
Methods
A computer search of medical records from May 1991 to April 2001 identified a total of 111 women who underwent myomectomy at time of cesarean delivery and 257 women with documented fibroids during the index pregnancy who underwent cesarean delivery alone. Charts were reviewed for the following outcome variables: change in hematocrit from preoperative to postoperative period, length of operation, length of postpartum stay, incidence of postpartum fever, and incidence of hemorrhage. Hemorrhage was defined as a change in hematocrit of 10 points or the need for intraoperative blood transfusion.
Results
The incidence of hemorrhage in the study group was 12.6% as compared with 12.8% in the control group (p = 0.95). There was also no statistically significant increase in the incidence of postpartum fever, operating time, and length of postpartum stay. No patient in either group required hysterectomy or embolization. Size of fibroid did not appear to affect the incidence of hemorrhage. After stratifying the procedures by type of fibroid removed, intramural myomectomy was found to be associated with a 21.2% incidence of hemorrhage compared with 12.8% in the control group, but this difference was not statistically significant (p = 0.08). This study had 80% power to detect a two-fold increase in the overall incidence of hemorrhage.
Conclusion
In selected patients, myomectomy during cesarean delivery does not appear to result in an increased risk of intrapartum or short-term postpartum morbidity.
doi:10.1186/1471-2393-4-14
PMCID: PMC487902  PMID: 15257757
15.  Prenatal diagnosis of pygopagus tetrapus parasitic twin: case report 
Background
Asymmetric and parasitic conjoined twins are rarer anomalies of monochorionic monoamniotic twins, consisting of an incomplete twin attached to the fully developed body of the co-twin.
Case presentation
A 30-year-old multigravid woman referred to maternal fetal unit due to polyhydramnios at 28th week of gestation. Sonographic examination revealed a single fetus and polyhydramnios with amniotic fluid index 30 cm. The fetus had normal apparent single head, spine, thorax, abdomen, two upper and two lower limbs, and two relatively well developed rudimentary parasitic lower limbs at sacral region. Lower limbs of the autosite were moving freelly but no movement was detected at the parasite. The parasite contained irregular lower limbs and left foot with three toes. Short and deformed long bones were also present in the parasitic limbs. A Cesarean section was performed at 38th week of gestation and a live female infant weighing 3600 g was delivered. The parasitic lower limbs were totally excised. Post-operative period was uneventful and the newborn was discharged as healthy. Post-natal follow-up was normal at nine-month-old.
Conclusion
Pygopagus tetrapus parasitic twin is a rare form of conjoined twins and in utero diagnosis with ultrasound assists in prenatal management and counselling with parents.
doi:10.1186/1471-2393-4-13
PMCID: PMC481071  PMID: 15251046
16.  An ethnic predilection for fetal echogenic intracardiac focus identified during targeted midtrimester ultrasound examination: A retrospective review 
Background
Echogenic intracardiac focus (EIF) has been identified as a common ultrasound finding in association with fetal aneuploidy. Little is known about the association of this soft marker aneuploidy in various ethnic groups. Although it is commonly thought Asians in general have a higher incidence of EIF, it is unknown whether this also applies to Japanese as a subpopulation. The purpose of this study is to determine the antenatal incidence and postnatal significance of EIF observed during sonography in Japanese patients.
Methods
A cohort of Japanese patients who underwent ultrasound screening from 1997 to 1999 in the ultrasound unit at the New York University School of Medicine was identified. Variables included age, gestational age, serum markers, and the presence or absence of aneuploidy. Patients with first degree paternal or maternal Japanese ancestry were included for analysis. Examinations were performed between 14 and 24 weeks gestation. The prevalence of EIF was calculated. The control group was based on previously published data in the U.S (7.3% prevalence).
Results
A total of 154 subjects were identified, 148 were available for final analysis. Twenty-two fetuses had an EIF, 19 (86.4%) left-sided, 3 (13.6%) right-sided. Seventeen patients had other sonographic markers associated with aneuploidy. The mean maternal age at diagnosis was 30.7 ± 3.9 years and the mean gestational age was 19.8 ± 1.6 weeks. The prevalence of EIF was 14.8%. Compared to published population prevalence, there was a statistically significant difference (p < 0.005). No abnormal karyotypes were found.
Conclusion
Asians of Japanese origin may have a higher prevalence of echogenic intracardiac foci, thus affecting the positive predictive value of this sonographic marker for aneuploidy.
doi:10.1186/1471-2393-4-12
PMCID: PMC449713  PMID: 15219230
17.  Use of hormonal contraceptives and occurrence of pregnancy-related pelvic pain: a prospective cohort study in Norway 
Background
Pregnancy-related pelvic pain is a common condition, and use of hormonal contraceptives before pregnancy has been proposed as a risk factor. We used data from a sub-sample of women participating in the "Norwegian Women and Cancer study" (NOWAC) to assess the association between hormonal contraceptive use and pelvic pain in pregnancy.
Methods
From a sub-group of 2078 parous women participating in the NOWAC study, information was collected from a self-instructive four-page questionnaire containing questions about lifestyle and medical conditions. We calculated odds ratios (OR) and 95% confidence intervals (CI), using unconditional logistic regression.
Results
In this study, the prevalence of pelvic pain in women was 26.5% during the first pregnancy and increased with parity. Use of hormonal contraceptives before a woman's first pregnancy was associated with an increased risk of pelvic pain in her first pregnancy (OR = 1.6; 95% confidence interval 1.2–2.2). There was no association between use of hormonal contraceptives and pelvic pain in the second or third pregnancy. Occurrence of pelvic pain in a previous pregnancy was the only factor associated with pelvic pain in subsequent pregnancies (OR = 51.1; 95% CI 32.9–79.5 in the second pregnancy and OR = 28.3; 95% CI 15.4–53.1 in the third pregnancy).
Conclusion
Use of hormonal contraceptives was associated with an increased risk of pelvic pain in a woman's first pregnancy. The most important determinant of pelvic pain in the second or third pregnancy was the history of pelvic pain in the preceding pregnancy.
doi:10.1186/1471-2393-4-11
PMCID: PMC446199  PMID: 15212688
18.  Racial discrepancies in the association between paternal vs. maternal educational level and risk of low birthweight in Washington State 
Background
The role of paternal factors in determining the risk of adverse pregnancy outcomes has received less attention than maternal factors. Similarly, the interaction between the effects of race and socioeconomic status (SES) on pregnancy outcomes is not well known. Our objective was to assess the relative importance of paternal vs. maternal education in relation to risk of low birth weight (LBW) across different racial groups.
Methods
We conducted a retrospective population-based cohort study using Washington state birth certificate data from 1992 to 1996 (n = 264,789). We assessed the associations between maternal or paternal education and LBW, adjusting for demographic variables, health services factors, and maternal behavioral and obstetrical factors.
Results
Paternal educational level was independently associated with LBW after adjustment for race, maternal education, demographic characteristics, health services factors; and other maternal factors. We found an interaction between the race and maternal education on risk of LBW. In whites, maternal education was independently associated with LBW. However, in the remainder of the sample, maternal education had a minimal effect on LBW.
Conclusions
The degree of association between maternal education and LBW delivery was different in whites than in members of other racial groups. Paternal education was associated with LBW in both whites and non-whites. Further studies are needed to understand why maternal education may impact pregnancy outcomes differently depending on race and why paternal education may play a more important role than maternal education in some racial categories.
doi:10.1186/1471-2393-4-10
PMCID: PMC446198  PMID: 15202949
19.  Analysis of neonatal mortality:is standardizing for relative birth weight biased? 
Background
Infant mortality has traditionally been analyzed as a function of birth weight and birth weight-specific mortality. Often, however, when comparing two populations, the population with higher overall mortality has lower mortality at low birth weights and a reversed pattern at higher birth weights. Methods standardizing birth weight, such as the "relative birth weight", have been proposed to eliminate these crossover effects, but such methods do not account for the separate contributions to birth weight of gestational age and fetal "growth."
Methods
Using data for singleton U.S. Blacks (n = 3,683,572) and Whites (n = 18,409,287), we compared neonatal mortality, gestational age, and the difference between the observed birth weight and the optimal birth weight (the weight at which neonatal mortality was lowest) among Black and White infants at the same relative birth weight.
Results
At relative birth weights below zero, gestational ages were, on average, 2.4 ± 1.5 (mean ± standard deviation) weeks shorter for Blacks than for Whites for the same relative birth weight. At relative birth weights above zero, no differences were observed in gestational age, but the optimal birth weight occurred at a much higher relative birth weight in Whites than in Blacks (4150 vs. 3550 g).
Conclusions
Our results suggest that comparisons of neonatal mortality between groups using "relative" birth weight may be potentially biased by differences in gestational age at low birth weights, and by the distance from the optimal birth weight at higher birth weights.
doi:10.1186/1471-2393-4-9
PMCID: PMC441380  PMID: 15180905
Birth weight; gestational age; relative birth weight; optimal birth weight
20.  Socioeconomic and physical distance to the maternity hospital as predictors for place of delivery: an observation study from Nepal 
Background
Although the debate on the safety and women's right of choice to a home delivery vs. hospital delivery continues in the developed countries, an undesirable outcome of home delivery, such as high maternal and perinatal mortality, is documented in developing countries. The objective was to study whether socio-economic factors, distance to maternity hospital, ethnicity, type and size of family, obstetric history and antenatal care received in present pregnancy affected the choice between home and hospital delivery in a developing country.
Methods
This cross-sectional study was done during June, 2001 to January 2002 in an administratively and geographically well-defined territory with a population of 88,547, stretching from urban to adjacent rural part of Kathmandu and Dhading Districts of Nepal with maximum of 5 hrs of distance from Maternity hospital. There were no intermediate level of private or government hospital or maternity homes in the study area. Interviews were carried out on 308 women who delivered within 45 days of the date of the interview with a pre-tested structured questionnaire.
Results
A distance of more than one hour to the maternity hospital (OR = 7.9), low amenity score status (OR = 4.4), low education (OR = 2.9), multi-parity (OR = 2.4), and not seeking antenatal care in the present pregnancy (OR = 4.6) were statistically significantly associated with an increased risk of home delivery. Ethnicity, obstetric history, age of mother, ritual observance of menarche, type and size of family and who is head of household were not statistically significantly associated with the place of delivery.
Conclusions
The socio-economic standing of the household was a stronger predictor of place of delivery compared to ethnicity, the internal family structure such as type and size of family, head of household, or observation of ritual days by the mother of an important event like menarche. The results suggested that mothers, who were in the low-socio-economic scale, delivered at home more frequently in a developing country like Nepal.
doi:10.1186/1471-2393-4-8
PMCID: PMC425583  PMID: 15154970
socio-economic status; distance; place of delivery
21.  A parsimonious explanation for intersecting perinatal mortality curves: understanding the effects of race and of maternal smoking 
Background
Neonatal mortality rates among black infants are lower than neonatal mortality rates among white infants at birth weights <3000 g, whereas white infants have a survival advantage at higher birth weights. This finding is also observed when birth weight-specific neonatal mortality rates are compared between infants of smokers and non-smokers. We provide a parsimonious explanation for this paradoxical phenomenon.
Methods
We used data on births in the United States in 1997 after excluding those with a birth weight <500 g or a gestational age <22 weeks. Birth weight- and gestational age-specific perinatal mortality rates were calculated per convention (using total live births at each birth weight/gestational age as the denominator) and also using the fetuses at risk of death at each gestational age.
Results
Perinatal mortality rates (calculated per convention) were lower among blacks than whites at lower birth weights and at preterm gestational ages, while blacks had higher mortality rates at higher birth weights and later gestational ages. With the fetuses-at-risk approach, mortality curves did not intersect; blacks had higher mortality rates at all gestational ages. Increases in birth rates and (especially) growth-restriction rates presaged gestational age-dependent increases in perinatal mortality. Similar findings were obtained in comparisons of smokers versus nonsmokers.
Conclusions
Formulating perinatal risk based on the fetuses-at-risk approach solves the intersecting perinatal mortality curves paradox; blacks have higher perinatal mortality rates than whites and smokers have higher perinatal mortality rates than nonsmokers at all gestational ages and birth weights.
doi:10.1186/1471-2393-4-7
PMCID: PMC419704  PMID: 15090071
22.  Dependency of magnetocardiographically determined fetal cardiac time intervals on gestational age, gender and postnatal biometrics in healthy pregnancies 
Background
Magnetocardiography enables the precise determination of fetal cardiac time intervals (CTI) as early as the second trimester of pregnancy. It has been shown that fetal CTI change in course of gestation. The aim of this work was to investigate the dependency of fetal CTI on gestational age, gender and postnatal biometric data in a substantial sample of subjects during normal pregnancy.
Methods
A total of 230 fetal magnetocardiograms were obtained in 47 healthy fetuses between the 15th and 42nd week of gestation. In each recording, after subtraction of the maternal cardiac artifact and the identification of fetal beats, fetal PQRST courses were signal averaged. On the basis of therein detected wave onsets and ends, the following CTI were determined: P wave, PR interval, PQ interval, QRS complex, ST segment, T wave, QT and QTc interval. Using regression analysis, the dependency of the CTI were examined with respect to gestational age, gender and postnatal biometric data.
Results
Atrioventricular conduction and ventricular depolarization times could be determined dependably whereas the T wave was often difficult to detect. Linear and nonlinear regression analysis established strong dependency on age for the P wave and QRS complex (r2 = 0.67, p < 0.001 and r2 = 0.66, p < 0.001) as well as an identifiable trend for the PR and PQ intervals (r2 = 0.21, p < 0.001 and r2 = 0.13, p < 0.001). Gender differences were found only for the QRS complex from the 31st week onward (p < 0.05). The influence on the P wave or QRS complex of biometric data, collected in a subgroup in whom recordings were available within 1 week of birth, did not display statistical significance.
Conclusion
We conclude that 1) from approximately the 18th week to term, fetal CTI which quantify depolarization times can be reliably determined using magnetocardiography, 2) the P wave and QRS complex duration show a high dependency on age which to a large part reflects fetal growth and 3) fetal gender plays a role in QRS complex duration in the third trimester. Fetal development is thus in part reflected in the CTI and may be useful in the identification of intrauterine growth retardation.
doi:10.1186/1471-2393-4-6
PMCID: PMC411040  PMID: 15061871
23.  The Magpie Trial follow up study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia [ISRCTN86938761] 
Background
The Magpie Trial compared magnesium sulphate with placebo for women with pre-eclampsia. 10,141 women were recruited, 8804 before delivery. Overall, 9024 children were included in the analysis of outcome at discharge from hospital. Magnesium sulphate more than halved the risk of eclampsia, and probably reduced the risk of maternal death. There did not appear to be any substantive harmful effects on the baby, in the short term. It is now important to assess whether these benefits persist, and to provide adequate reassurance about longer term safety.
The main objective of the Magpie Trial Follow Up Study is to assess whether in utero exposure to magnesium sulphate has a clinically important effect on the child's chance of surviving without major neurosensory disability. Other objectives are to assess long term outcome for the mother, and to develop and assess appropriate strategies for following up large numbers of children in perinatal trials.
Study design
Follow up is only feasible in selected centres. We therefore anticipate contacting 2800–3350 families, for 2435–2915 of whom the woman was randomised before delivery. A further 280–335 children would have been eligible for follow up if they had survived. The total sample size for the children is therefore 3080–3685, 2680–3210 of whom will have been born to women randomised before delivery.
Families eligible for the follow up will be contacted, and surviving children screened using the Ages and Stages Questionnaires. Children who screen positive, and a sample of those who screen negative, will whenever possible have a paediatric and neurodevelopmental assessment. When women are contacted to ask how their child is, they will also be asked about their own health. The primary outcome is a composite measure of death or neurosensory disability for the child at 18 months.
Discussion
The Follow Up Study began in 2002, and now involves collaborators in 19 countries. Data collection will close at the end of 2003.
doi:10.1186/1471-2393-4-5
PMCID: PMC416479  PMID: 15113445
24.  Effects of carrying a pregnancy and of method of delivery on urinary incontinence: a prospective cohort study 
Background
This study was carried out to identify risk factors associated with urinary incontinence in women three months after giving birth.
Methods
Urinary incontinence before and during pregnancy was assessed at study enrolment early in the third trimester. Incontinence was re-assessed three months postpartum. Logistic regression analysis was used to assess the role of maternal and obstetric factors in causing postpartum urinary incontinence. This prospective cohort study in 949 pregnant women in Quebec, Canada was nested within a randomised controlled trial of prenatal perineal massage.
Results
Postpartum urinary incontinence was increased with prepregnancy incontinence (adjusted odds ratio [adj0R] 6.44, 95% CI 4.15, 9.98), incontinence beginning during pregnancy (adjOR 1.93, 95% CI 1.32, 2.83), and higher prepregnancy body mass index (adjOR 1.07/unit of BMI, 95% CI 1.03,1.11). Caesarean section was highly protective (adjOR 0.27, 95% CI 0.14, 0.50). While there was a trend towards increasing incontinence with forceps delivery (adjOR 1.73, 95% CI 0.96, 3.13) this was not statistically significant. The weight of the baby, episiotomy, the length of the second stage of labour, and epidural analgesia were not predictive of urinary incontinence. Nor was prenatal perineal massage, the randomised controlled trial intervention. When the analysis was limited to women having their first vaginal birth, the same risk factors were important, with similar adjusted odds ratios.
Conclusions
Urinary incontinence during pregnancy is extremely common, affecting over half of pregnant women. Urinary incontinence beginning during pregnancy roughly doubles the likelihood of urinary incontinence at 3 months postpartum, regardless whether delivery is vaginal or by Caesarean section.
doi:10.1186/1471-2393-4-4
PMCID: PMC375532  PMID: 15053837
25.  Mobility and maternal position during childbirth in Tanzania: an exploratory study at four government hospitals 
Background
Emerging research evidence suggests a potential benefit in being upright in the first stage of labour and a systematic review of trials suggests both benefits and harmful effects associated with being upright in the second stage of labour. Implementing evidence-based obstetric care in African countries with scarce resources is particularly challenging, and requires an understanding of the cumulative nature of science and commitment to applying the most up to date evidence to clinical decisions. In this study, we documented current practice rates, explored the barriers and opportunities to implementing these procedures from the provider perspective, and documented women's preferences and satisfaction with care.
Methods
This was an exploratory study using quantitative and qualitative methods. Practice rates were determined by exit interviews with a consecutive sample of postnatal women. Provider views were explored using semi-structured interviews (with doctors and traditional birth attendants) and focus group discussions (with midwives). The study was conducted at four government hospitals, two in Dar es Salaam and two in the neighbouring Coast region, Tanzania.
Main outcome measures
Practice rates for mobility during labour and delivery position; women's experiences, preferences and views about the care provided; and provider views of current practice and barriers and opportunities to evidence-based obstetric practice.
Results
Across all study sites more women were mobile at home (15.0%) than in the labour ward (2.9%), but movement was quite restricted at home before women were admitted to labour ward (51.6% chose to rest with little movement). Supine position for delivery was used routinely at all four hospitals; this was consistent with women's preferred choice of position, although very few women are aware of other positions. Qualitative findings suggest obstetricians and midwives favoured confining to bed during the first stage of labour, and supine position for delivery.
Conclusions
The barriers to change appear to be complicated and require providers to want to change, and women to be informed of alternative positions during the first stage of labour and delivery. We believe that highlighting the gap between actual practice and current evidence provides a platform for dialogue with providers to evaluate the threats and opportunities for changing practice.
doi:10.1186/1471-2393-4-3
PMCID: PMC394328  PMID: 15113446

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