bluuebunny/crossref_metadata_2025_split huggingface dataset:
How Transparent are EU ‘Comitology’ Committees in Practice?
Authors: Brandsma Gijs Jan , Curtin Deirdre , Meijer Albert 
Published: October 2008

AbstractMuch of the debate on transparency is normative in nature: more transparency is ‘good’ from the perspective of democratic accountability. After all, without information on what decisions are being taken and by whom, it will not be possible for various accountability forums to hold actors to account. This article goes beyond the rhetoric on the need for more transparency in the political system of the EU and examines, in practice as a matter of empirical research, how much transparency there really is. It also goes beyond a purely legal approach to access to information that depends upon the active participation of citizens and others in challenging refusals by specific institutions to grant access to specific documents. We are interested rather in the question as to what extent the institutions are systematically and pro‐actively providing access to their documents via the internet. We focus on the Register of Comitology of the European Commission as a relatively limited case study and, within this context, limit ourselves further to a study of all the documents published in the latest year for which a benchmark was available—2005. Are all comitology documents that exist in fact made available through this public register?
Quality of child–parent attachment moderates the impact of antenatal stress on child fearfulness
Authors: Bergman K. , Sarkar P. , Glover V. , O’Connor T.G. 
Published: October 2008

Background:  Animal studies have shown that prenatal stress has persisting effects on several aspects of offspring development; more recent studies show that this effect may be eliminated by positive postnatal rearing. Human studies of prenatal anxiety/stress are now also beginning to document links between antenatal stress/anxiety and behavioural and cognitive development of the child; however, there is no human evidence as to whether the early caregiving environment moderates the effect of antenatal anxiety/stress on child outcomes.Methods:  Antenatal and postnatal measures of stress were collected on 123 women who were recruited from an antenatal clinic. Laboratory‐based assessment of the children’s cognitive development and fearfulness were assessed when the children were aged 17 months. In addition, child–parent attachment quality was assessed using the Strange Situation.Results:  Attachment classification moderated the link between antenatal stress and observed fearfulness. The effect of antenatal stress on fearfulness was most accentuated in children with an Insecure/Resistant attachment classification; the significant antenatal stress × attachment classification interaction held after controlling for postnatal stress and obstetric, social and demographic factors. Attachment did not moderate the effects of antenatal anxiety on cognitive development.Discussion:  These findings provide the first human evidence that postnatal parenting may moderate the adverse effects of antenatal stress. These results raise developmental questions about the timing and effect of interventions to reduce the adverse effects of antenatal stress exposure.
Cocoa butter lotion for prevention of striae gravidarum: a double‐blind, randomised and placebo‐controlled trial*
Authors: Osman H , Usta IM , Rubeiz N , Abu‐Rustum R , Charara I , Nassar AH 
Published: October 2008

Objective  To assess whether application of cocoa butter lotion reduces the development of striae gravidarum (SG).Design  Multicentre, double‐blind, randomised and placebo‐controlled trial.Setting  Beirut and Tripoli, Lebanon.Population  Nulliparous women presenting for prenatal care.Methods  Nulliparous women presenting in the first trimester were randomly assigned to receive a lotion containing cocoa butter or a placebo lotion. Women were instructed to apply the assigned lotion daily until delivery.Main outcome measure The development of striae over the abdomen, breasts and thighs postpartum.Results Of 210 women enrolled, 175 (83%) completed the study. Ninety‐one women received the study lotion and 84 received the placebo. There was no difference in the development of SG (45.1% versus 48.8%; P = 0.730) or the severity of SG between cases and controls. The results did not change when presence of stretch marks at enrolment or compliance with the regimen were taken into account.Conclusion  Topical application of a lotion containing cocoa butter does not appear to reduce the likelihood of developing striae gravidarum.
A randomised controlled trial of early versus delayed oxytocin augmentation to treat primary dysfunctional labour in nulliparous women
Authors: Hinshaw K , Simpson S , Cummings S , Hildreth A , Thornton J 
Published: October 2008

Background  Oxytocin is widely used to speed up slow labour, especially in nulliparous women, but randomised trials, apart from one reported only in abstract, have been too small to exclude important effects.Objective  To test the hypothesis that early use of oxytocin reduces the need for caesarean delivery.Design  A randomised controlled trial.Setting  Twelve obstetric units within the Northern and Yorkshire regions in the North East of England.Participants  A total of 412 low‐risk nulliparous women in spontaneous labour at term, who had been diagnosed with primary dysfunctional labour were recruited from January 1999 to December 2001.Intervention  Immediate oxytocin administration (active group) or oxytocin withheld for up to 8 hours (conservative group).Main outcome measures  Caesarean section and operative vaginal delivery rates. The length of labour measured from the time of randomisation to delivery. The rate of maternal Edinburgh Postnatal Depression Scale (EPDS) greater than 12 (major depression) within 48 hours of delivery.Results  The caesarean section rates were 13.5% active versus 13.7% controls (OR 0.98, 95% CI 0.6–1.7). Operative delivery, 24.5% versus 30.9% (OR 0.73, 95% CI 0.5–1.1). The median (interquartile range) randomisation to delivery interval in the active group was 5 hours 52 minutes (3:57–8:28) and in the conservative group 9 hours 8 minutes (5:06–13:16) (P < 0.001). The rate of EPDS >12 was 20% in the active arm versus 15% among controls (OR 1.26, 95% CI 0.7–2.2). There was one perinatal death in each group and no major differences in perinatal outcomes.Conclusions  Among nulliparous women with primary dysfunctional labour, early use of oxytocin does not reduce caesarean section or short‐term postnatal depression. However, it shortens labour considerably and may reduce operative vaginal deliveries.
Serious toxicity associated with continuous nevirapine‐based HAART in pregnancy
Authors: Van Schalkwyk JE , Alimenti A , Khoo D , Maan E , Forbes JC , Burdge DR , Gilgoff S , Money DM 
Published: October 2008

Objective  This study was designed to determine the safety of nevirapine (NVP)‐based highly active antiretroviral therapy (HAART) in a cohort of HIV‐positive pregnant women.Design  This was a prospective cohort study of HIV‐positive pregnant women.Population and setting  All HIV‐positive women treated with HAART during pregnancy from January 1997 to February 2004 at the British Columbia (BC) Women’s Hospital in Vancouver, BC, Canada.Methods  Demographic and clinical data were collected to compare antiretroviral drug toxicities in women treated antenatally with NVP‐based or non‐NVP‐based HAART. Multivariate analyses were then used to investigate determinants of toxicity.Results  From 1997 to 2004, 103 HIV‐positive pregnant women received HAART. Equivalent numbers of women were initially treated with NVP‐based (54%) and non‐NVP‐based (46%) HAART. The groups did not differ by clinical or demographic parameters and duration of HAART exposure was similar between groups. Toxicities necessitating treatment discontinuation were observed in 6 of 56 NVP‐exposed women (2 cases each of grade 2, 3, and 4 toxicity) compared with 1 of 47 in the non‐NVP‐exposed women. First time use of NVP approached significance as a predictor for toxicity, with a toxicity rate of 12.5% (6/48) observed among those taking NVP for the first time (adjusted OR 2.68, 95% CI 0.49–14.6).Conclusion  Continuous NVP use in pregnancy resulted in a relatively higher rate of toxicity, and all cases of NVP toxicity occurred in women exposed to NVP for the first time during pregnancy.
Transgenerational effects of prenatal exposure to the Dutch famine on neonatal adiposity and health in later life
Authors: Painter RC , Osmond C , Gluckman P , Hanson M , Phillips DIW , Roseboom TJ 
Published: October 2008

Objective  Maternal undernutrition during gestation is associated with increased metabolic and cardiovascular disease in the offspring. We investigated whether these effects may persist in subsequent generations.Design  Historical cohort study.Setting  Interview during a clinic or home visit or by telephone.Population  Men and women born in the Wilhelmina Gasthuis in Amsterdam between November 1943 and February 1947.Methods  We interviewed cohort members (F1) born around the time of the 1944–45 Dutch famine, who were exposed or unexposed to famine in utero, about their offspring (F2).Main outcome measures  Birthweight, birth length, ponderal index and health in later life (as reported by F1) of the offspring (F2) of 855 participating cohort members, according to F1 famine exposure in utero.Results  F1 famine exposure in utero did not affect F2 (n = 1496) birthweight, but, among the offspring of famine‐exposed F1 women, F2 birth length was decreased (−0.6 cm, P adjusted for F2 gender and birth order = 0.01) and F2 ponderal index was increased (+1.2 kg/m3, P adjusted for F2 gender and birth order = 0.001). The association remained unaltered after adjusting for possible confounders. The offspring of F1 women who were exposed to famine in utero also had poor health 1.8 (95% CI 1.1–2.7) times more frequently in later life (due to miscellaneous causes) than that of F1 unexposed women.Conclusions  We did not find transgenerational effects of prenatal exposure to famine on birthweight nor on cardiovascular and metabolic disease rates. F1 famine exposure in utero was, however, associated with increased F2 neonatal adiposity and poor health in later life. Our findings may imply that the increase in chronic disease after famine exposure in utero is not limited to the F1 generation but persists in the F2 generation.
Induction of labour in nulliparous and multiparous women: a UK, multicentre, open‐label study of intravaginal misoprostol in comparison with dinoprostone
Authors: Calder AA , Loughney AD , Weir CJ , Barber JW 
Published: October 2008

Objective  To compare the efficacy and safety of a 25‐microgram vaginal tablet of misoprostol (APL202) with dinoprostone (3‐mg vaginal tablet) in cervical ripening and labour induction.Design  A randomised, open‐label, noninferiority, comparative study in two maternal populations.Setting  Eighteen NHS study centres across the UK.Population  Nulliparous or multiparous women with a singleton pregnancy eligible for induction of labour.Methods  Women were randomised to receive either misoprostol, initially 25 micrograms (50 micrograms in nulliparous women with Bishop score ≤4) followed by 25 micrograms after 4 and 8 hours, or dinoprostone, initially 3 mg followed by 3 mg after 6 hours. Clinical noninferiority of misoprostol was defined as an absolute difference between treatments of no more than 10% for the primary outcome.Main outcome measures  The number of vaginal deliveries achieved within 24 hours of labour induction. Maternal and fetal safety outcomes.Results  A total of 626 women were randomised to misoprostol (n = 318) or dinoprostone (n = 308) treatment. The rate of vaginal deliveries achieved within 24 hours of induction did not significantly differ between the misoprostol and dinoprostone (43 versus 47%; 3.74% difference, 95% CI −3.58 to 11.05, respectively) treatment groups. The treatments were generally comparable for other secondary efficacy measures. Maternal and fetal adverse events were similarly distributed across the misoprostol and dinoprostone groups.Conclusions  Low‐dose misoprostol is efficacious in cervical ripening and labour induction and demonstrates a similar fetal and maternal safety profile to dinoprostone.
Mannose‐binding lectin gene polymorphism and resistance to therapy in women with recurrent vulvovaginal candidiasis
Authors: Donders GGG , Babula O , Bellen G , Linhares IM , Witkin SS 
Published: October 2008

Precis  Women with recurrent vulvovaginal candidiasis (RVC) due to a polymorphism in codon 54 of the MBL2 gene respond better to fluconazole maintenance therapy than do women with other underlying causes.Objective  To explain differences in response rates to maintenance therapy with fluconazole in women suffering from RVC by evaluating associations with a polymorphism in the gene coding for mannose‐binding lectin (MBL).Design  Follow‐up study, neted case‐control group.Setting  Women attending vulvoginitis clinic for RVC.Population  Women participating in a multicentric study in Belgium with a degressive dose of fluconazole for RVC (the ReCiDiF trial) were divided into good responders, intermediate responders and nonresponders according to the number of relapses they experienced during therapy. From 109 of these women with adequate follow‐up data, vaginal lavage with 2 ml of saline were performed at the moment of a proven acute attack at inclusion in the study, before maintenance treatment was started. A buccal swab was obtained from 55 age‐matched women without a history of Candida infections, serving as a control group.Methods  Extracted DNA from buccal or vaginal cells was tested for codon 54 MBL2 gene polymorphism by polymerase chain reaction and endonuclease digestion.Main outcome measures  Frequency of MBL2 condon 54 allele B in women with optimal or poor response to maintenance therapy in composition with controls.Results  Women (n = 109) suffering from RVC were more likely to carry the variant MBL2 codon 54 allele B than control women (20 versus 6.6%, OR 3.4 [95% CI 1.3–8.2], P = 0.01). B alleles were present in 25% of the 36 women not suffering from any recurrence during the maintenance therapy with decreasing doses of fluconazole (OR 4.9 [95% CI 1.9–12.5], P = 0.0007 versus controls), in 20% of the 43 women with sporadic recurrences (OR 3.6 [95% CI 1.4–9.2], P = 0.007 versus controls) and in 15% of the 30 women who had to interrupt the treatment regimen due to frequent relapses (P = 0.097 versus controls).Conclusions  The MBL2 codon 54 gene polymorphism is more frequent in Belgian women suffering from RVC than in controls. The presence of the B allele is associated with a superior response to fluconazole maintenance therapy as compared with RVC patients without this polymorphism. We conclude that RVC due to deficient MBL production is more easily helped with antifungal medication than is RVC due to some other mechanism.
A randomised controlled trial comparing GnRH antagonist Cetrorelix with GnRH agonist Leuprorelin for endometrial thinning prior to transcervical resection of endometrium
Authors: Bhatia K , Doonan Y , Giannakou A , Bentick B 
Published: October 2008

Objectives  To compare the effectiveness of leuprorelin and cetrorelix, when used as preoperative endometrial thinning agents prior to transcervical resection of endometrium (TCRE).Design  A prospective, double‐blind randomised controlled trial.Setting  Gynaecological department of a UK district general hospital.Participants  A total of 106 premenopausal women with dysfunctional uterine bleeding, undergoing TCRE.Interventions  Women were equally randomised to 3.75 mg of leuprorelin acetate (3–4 weeks) or 3 mg cetrorelix (4–7 days) prior to TCRE. About 1 ml saline was given as placebo in both arms.Main outcome measures  Amenorrhoea rate at 6 months, endometrial thickness using transvaginal ultrasound on the day of operation.Results  A total of 100 women completed the trial with no loss to follow up. Amenorrhoea rate at 6 months after surgery was high in both groups (80% cetrorelix and 84% leuprorelin) with no statistical significance. All endometrial outcome measures including endometrial thickness on ultrasound, histology and operative appearance were more favourable in leuprorelin group as compared with cetrorelix (P values 0.013, <0.001 and 0.003 respectively). More women in leuprorelin group had hot flushes as compared with cetrorelix (15/50 versus 6/50; P = 0.047). No significant differences were seen in other outcome measures.Conclusions  In dosages used, leuprorelin produced more consistent thinning of the endometrium as compared with cetrorelix, although this did not make any significant difference to operative or menstrual outcomes. The endometrial thinning effect with cetrorelix does appear to be more favourable than that seen at postmenstrual phase in other studies. The optimum (possibly higher) dosage of cetrorelix for this purpose has not yet been established.
Experiences and expectations of women with urogenital prolapse: a quantitative and qualitative exploration
Authors: Srikrishna S , Robinson D , Cardozo L , Cartwright R 
Published: October 2008

Objective  To explore the expectations and goals of women undergoing surgery for urogenital prolapse using both a quantitative quality of life approach exploring symptom bother and a qualitative interview‐based approach exploring patient goals and expectations.Design  Prospective observational study.Setting  Tertiary referral centre for urogynaecology.Population  Forty‐three women with symptomatic pelvic organ prolapse were recruited from the waiting list for pelvic floor reconstructive surgery.Methods  All women were assessed with a structured clinical interview on an individual basis. The data obtained were transcribed verbatim and then analysed thematically based on the grounded theory. Individual codes and subcodes were identified to develop a coding framework. The prolapse quality‐of‐life (pQoL) questionnaire was used to determine the impact of pelvic organ prolapse on the woman’s daily life. We arbitrarily classified ‘bother’ as minimal, mild, moderate and marked if scores ranged from 0 to 25, 25–50, 50–75 and 75–100, respectively. The degree of prolapse was objectively quantified using the pelvic organ prolapse quantification (POP‐Q) system. Quantitative data were analysed using SPSS. Ethical approval was obtained from the Kings College Hospital Ethics Committee.Main outcome measures  Quantitative data from POP‐Q, subjective data from pQoL, qualitative data based on the structured clinical interview.Results  Forty‐three women were recruited over the first 1 year of the study. Their mean age was 56 years (range 36–78) and mean parity was 2 (range 0–6). The mean ordinal stage of the prolapse was 2 (range stages 1–4). Quantitative analysis of the pQoL data suggested that the main domains affected were prolapse impact on life (mean score 74.71) and personal relationships (mean score 46.66). Qualitative analysis based on the clinical interview suggested that these women were most affected by the actual physical symptoms of prolapse (bulge, pain and bowel problems) as well by the impact prolapse has on their sexual function.Conclusions  While disease‐specific QoL questionnaires allow broad comparisons to be made assessing patient bother, they may lack the sensitivity to assess individual symptoms. A qualitative approach may individualise patient care and ultimately improve patient satisfaction and overall outcome when treating women complaining of urogenital prolapse.
Effect of margin status on cervical intraepithelial neoplasia recurrence following LLETZ in women over 50 years
Authors: Manchanda R , Baldwin P , Crawford R , Vowler SL , Moseley R , Latimer J , Welton K , Shafi M 
Published: October 2008

Objective  To establish the effect of margin status on recurrence following large loop excision of the transformation zone (LLETZ) in women over 50 years.Study design  Prospectively collected data of women over 50 years, who underwent LLETZ for suspected cervical intraepithelial neoplasia between 1998 and 2003, were analysed. Women were followed up for up to over 6 years.Setting  District colposcopy service based at a gynae‐oncology cancer centre.Main outcome measures  The main outcome measure included histologically detected recurrence. Any abnormal cytology on follow up was also documented.Methods  Prospectively collected data were analysed from the colposcopy database. Recurrence was analysed using Kaplan–Meir plots and Cox regression. Fisher’s exact test was used to determine the association between margins and grade. The Kruskal–Wallis and Mann–Whitney U tests were used to compare age and duration of follow up between groups.Results  A total of 118 women underwent LLETZ and 92 were included in the final analysis. Margins were designated as clear (n = 62), involved (n = 22) or uncertain (n = 8). Histological recurrence occurred in 12 while abnormal cytology was demonstrated in 17 women. One woman with involved margins developed cervical cancer. Individuals with clear margins were less likely to have recurrence than those with involved margins (Hazard Ratio (HR) 0.18, 95% CI: 0.06–0.59). Involved margins were more common with high‐grade than low‐grade lesions (P = 0.002).Conclusion  The data show an association between disease recurrence and the finding of involved margins in this cohort.
Prevalence and risk factors of severe obstetric haemorrhage
Authors: Al‐Zirqi I , Vangen S , Forsen L , Stray‐Pedersen B 
Published: October 2008

Objective  To determine the prevalence, causes, risk factors and acute maternal complications of severe obstetric haemorrhage.Design  Population‐based registry study.Population  All women giving birth (307 415) from 1 January 1999 to 30 April 2004 registered in the Medical Birth Registry of Norway. Information about socio‐economic risk factors was obtained from Statistics Norway.Methods  Cross‐tabulation was used to study prevalence, causes and acute maternal complications of severe obstetric haemorrhage. Associations of severe obstetric haemorrhage with demographic, medical and obstetric risk factors were estimated using multiple logistic regression models.Main outcome measure  Severe obstetric haemorrhage (blood loss of > 1500 ml or blood transfusion).Results  Severe obstetric haemorrhage was identified in 3501 women (1.1%). Uterine atony, retained placenta and trauma were identified causes in 30, 18 and 13.9% of women, respectively. The demographic factors of a maternal age of ≥30 years and South‐East Asian ethnicity were significantly associated with an increased risk of haemorrhage. The risk was lower in women of Middle Eastern ethnicity, more than three and two times higher for emergency caesarean delivery and elective caesarean than for vaginal birth, respectively, and substantially higher for multiple pregnancies, von Willebrand’s disease and anaemia (haemoglobin <9 g/dl) during pregnancy. Admissions to an intensive care unit, postpartum sepsis, hysterectomy, acute renal failure and maternal deaths were significantly more common among women with severe haemorrhage.Conclusion  The high prevalence of severe obstetric haemorrhage indicates the need to review labour management procedures. Demographic and medical risk factors can be managed with extra vigilance.