Obstetrics and Gynaecology - Research Publications

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    A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe).
    Beardsall, K ; Vanhaesebrouck, S ; Ogilvy-Stuart, AL ; Ahluwalia, JS ; Vanhole, C ; Palmer, C ; Midgley, P ; Thompson, M ; Cornette, L ; Weissenbruch, M ; Thio, M ; de Zegher, F ; Dunger, D (Springer Science and Business Media LLC, 2007-08-10)
    BACKGROUND: Studies in adult intensive care have highlighted the importance of insulin and improved glucose control on survival, with 32% reduction in mortality, 22% reduction in intensive care stay and halving of the incidence of bacteraemia. Very low birth weight infants requiring intensive care also have relative insulin deficiency often leading to hyperglycaemia during the first week of life. The physiological influences on insulin secretion and sensitivity, and the potential importance of glucose control at this time are not well established. However there is increasing evidence that the early postnatal period is critical for pancreatic development. At this time a complex set of signals appears to influence pancreatic development and beta cell survival. This has implications both in terms of acute glucose control but also relative insulin deficiency is likely to play a role in poor postnatal growth, which has been associated with later motor and cognitive impairment, and fewer beta cells are linked to risk of type 2 diabetes later in life. METHODS: A multi-centre, randomised controlled trial of early insulin replacement in very low birth weight babies (VLBW, birth weight < 1500 g). 500 infants will be recruited from 10 centres in the UK and Europe. Babies will be randomised to receive a continuous insulin infusion (0.05 units/kg/h) or to receive standard neonatal care from the first day of life and for the next 7 days. If blood glucose (BG) levels fall infants will receive 20% dextrose titrated to maintain normoglycaemia (4-8 mmol/l). If BG is consistently above 10 mmol/l babies will receive standard treatment with additional insulin infusion. The primary end point will be mortality on or before expected date of delivery, secondary end points will be markers of morbidity and include episodes of sepsis, severity of retinopathy, chronic lung disease and growth.
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    The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for children at 18 months
    Duley, L ; Farrell, B ; Armstrong, N ; Spark, P ; Roberts, B ; Smyth, R ; Tivnan, M ; Laws, A ; Corfield, N ; Salter, A ; Thorn, L ; Altman, D ; Yu, L-M ; Abalos, E ; Carroli, B ; Dellepiane, L ; Duarte, M ; Fernandez, H ; Giordano, D ; Altman, D ; Armstrong, N ; Clarke, M ; Duley, L ; Farrell, B ; Gray, A ; Hey, E ; Neilson, J ; Simon, J ; Spark, P ; Smyth, R ; Yu, L-M ; Doyle, L ; Hey, E ; Kelly, T ; Squires, J ; Altman, D ; Collins, R ; Duley, L ; Farrell, B ; Karaoglou, A ; Lilford, R ; Moodley, J ; Neilson, J ; Robson, S ; Roberts, I ; Rubin, P ; Thornton, J ; Twaddle, S ; Villar, J ; Walker, I ; Watkins, C ; Abalos, E ; Altman, D ; Armstrong, N ; Doyle, L ; Duley, L ; Farrell, B ; Hey, E ; Moodley, J ; Neilson, J ; Spark, P ; Smyth, R ; Yu, L-M ; Bimbashi, A ; Demalia, E ; Gliozheni, O ; Shpata, A ; Karolinski, A ; Lamas, M ; Pesaresi, M ; Wainer, V ; Barbato, W ; Paciocco, M ; Bertin, M ; Boiza, E ; Castaldi, J ; Partida, Y ; Farri, M ; Kerz, G ; Aguirre, J ; de Sagastiza, M ; Falcone, R ; Morales, E ; Carroli, G ; Krupitzky, S ; Lopez, S ; Palermo, M ; Varela, DM ; Delprato, H ; Camusso, H ; Curioni, M ; Ludmer, E ; Brandi, R ; Martin, R ; Mesas, W ; Taralli, R ; Lezaola, M ; Morosini, M ; Andina, E ; Bernal, L ; Estiu, M ; Ulens, E ; de Speranza, BO ; Peyrano, A ; Damiano, M ; Saumench, C ; Horn, J ; Pritchard, M ; Smith-Orr, V ; Wilson, M ; Lawrence, A ; Watson, D ; Crowther, C ; Paynter, J ; Mannan, M ; Shahidullah, M ; Shamsuddin, L ; Barros Santos, C ; Freire, S ; Melo, E ; Cobo, E ; Jaramillo, M ; Cardozo, C ; Fandino, N ; Gaitan, H ; Montano, L ; Lozano, J ; Rojas, M ; Breto Garcia, A ; Fuentes Ramirez, A ; Garcia Miras, R ; Sampera, S ; Farnot, U ; Gomez, E ; Rojas, G ; Valdez, R ; El-Kreem, HA ; Al-Hussaini, T ; Hammad, E ; Danso, K ; Kwapong, E ; Ofosu-Barko, F ; Jasper, MP ; Peedicayil, A ; Regi, A ; Sharma, R ; Chauhan, A ; Raut, V ; Udani, R ; Batra, S ; Muthal-Rathore, A ; Ramji, S ; Zutshi, V ; Balakrishnan, S ; Eapen, E ; Koshy, G ; Ambardar, B ; Vadakkepat, P ; Vaidya, D ; Lema, V ; Rijken, Y ; Tadesse, E ; Dada, O ; Sofekun, A ; Ohiaeri, C ; Runsewe-Abiodun, T ; Adewole, I ; Adeyemo, A ; Brown, B ; Oladokun, R ; Adewale, O ; Inimgba, N ; John, C ; Ogu, R ; Ekele, B ; Isah, A ; Onankpa, B ; Jamelle, R ; Junejo, D ; Faiz, NR ; Gul, F ; Sherin, A ; Bangash, K ; Mahmud, G ; Masud, K ; Tasneem, N ; Gassama, S ; Soyei, A ; Agarwal, P ; Rajadurai, V ; Hani, C ; Pirani, N ; Delport, S ; Macdonald, P ; Mokhondo, R ; Pattinson, R ; Zondo, M ; Adhikari, M ; Mnguni, N ; Moodley, J ; Carstens, M ; Kirsten, G ; Steyn, W ; van Zyl, J ; Helwig, A ; Jacobson, S-L ; Panosche, R ; Hammond, E ; Masanganise, L (WILEY, 2007-03-01)
    OBJECTIVE: To assess the long-term effects of in utero exposure to magnesium sulphate for children whose mothers had pre-eclampsia. DESIGN: Assessment at 18 months of age for children whose mothers were recruited to the Magpie Trial (recruitment 1998-2001 ISRCTN 86938761), which compared magnesium sulphate with placebo. SETTING: Follow-up of children born at 125 centres in 19 countries across five continents. POPULATION: A total of 6922 children were born to women randomised before delivery at follow-up centres. Of these, 2271 were not included for logistic reasons and 168 were excluded (101 at a centre where <20% were contacted, 40 whose death or disability was due to a problem at conception or embryogenesis and 27 whose parent/s opted out). Therefore, 4483 children were included in follow-up, of whom 3283 (73%) were contacted. METHODS: Assessment by questionnaire, with interview and neurodevelopmental testing of selected children. MAIN OUTCOME MEASURES: Death or neurosensory disability at age of 18 months. RESULTS: Of those allocated magnesium sulphate, 245/1635 (15.0%) were dead or had neurosensory disability at 18 months compared with 233/1648 (14.1%) allocated placebo (relative risk [RR] 1.06, 95% CI 0.90-1.25), and of survivors, 19/1409 (1.3%) had neurosensory disability at 18 months compared with 27/1442 (1.9%) (RR 0.72, 95% CI 0.40-1.29). There were no substantial differences in causes of death or in the risk of individual impairments or disabilities. CONCLUSIONS: The lower risk of eclampsia following prophylaxis with magnesium sulphate was not associated with a clear difference in the risk of death or disability for children at 18 months.
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    The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for women at 2 years
    Duley, L ; Farrell, B ; Armstrong, N ; Spark, P ; Roberts, B ; Smyth, R ; Tivnan, M ; Laws, A ; Corfield, N ; Salter, A ; Thorn, L ; Altman, D ; Yu, L-M ; Abalos, E ; Carroli, B ; Dellepiane, L ; Duarte, M ; Fernandez, H ; Giordano, D ; Clarke, M ; Gray, A ; Hey, E ; Neilson, J ; Simon, J ; Collins, R ; Karaoglou, A ; Lilford, R ; Moodley, J ; Robson, S ; Roberts, I ; Rubin, P ; Thornton, J ; Twaddle, S ; Villar, J ; Walker, I ; Watkins, C ; Doyle, L ; Bimbashi, A ; Demalia, E ; Gliozheni, O ; Shpata, A ; Karolinski, A ; Lamas, M ; Pesaresi, M ; Wainer, V ; Barbato, W ; Paciocco, M ; Bertin, M ; Boiza, E ; Castaldi, J ; Partida, Y ; Arias, C ; Farri, M ; Kerz, G ; Aguirre, J ; de Sagastizabal, M ; Falcone, R ; Morales, E ; Carroli, G ; Krupitzky, S ; Lopez, S ; Palermo, M ; Varela, DM ; Delprato, H ; Camusso, H ; Curioni, M ; Ludmer, E ; Brandi, R ; Martin, R ; Mesas, W ; Taralli, R ; Lezaola, M ; Morosini, M ; Andina, E ; Bernal, L ; Estiu, M ; Ulens, E ; de Speranza, BO ; Peyrano, A ; Damiano, M ; Saumench, C ; Horn, J ; Pritchard, M ; Smith-Orr, V ; Wilson, M ; Lawrence, A ; Watson, D ; Crowther, C ; Paynter, J ; Ashrafunnessa, ; Mannan, M ; Shahidullah, M ; Shamsuddin, L ; Santos, CB ; Freire, S ; Melo, E ; Cobo, E ; Jaramillo, M ; Cardozo, C ; Fandino, N ; Gaitan, H ; Montano, L ; Lozano, J ; Rojas, M ; Garcia, AB ; Ramirez, AF ; Miras, RG ; Sampera, S ; Farnot, U ; Gomez, E ; Rojas, G ; Valdes, R ; El-Kreem, HA ; Al-Hussaini, T ; Hammad, E ; Danso, K ; Kwapong, E ; Ofosu-Barko, F ; Jasper, MP ; Peedicayil, A ; Regi, A ; Sharma, R ; Chauhan, A ; Raut, V ; Udani, R ; Batra, S ; Muthal-Rathore, A ; Ramji, S ; Zutshi, V ; Balakrishnan, S ; Eapen, E ; Koshy, G ; Ambardar, B ; Vadakkepat, P ; Vaidya, D ; Lema, V ; Rijken, Y ; Tadesse, E ; Dada, O ; Sofekun, A ; Ohiaeri, C ; Runsewe-Abiodun, T ; Adewole, I ; Adeyemo, A ; Brown, B ; Oladokun, R ; Adewale, O ; Inimgba, N ; John, C ; Ogu, R ; Ekele, B ; Isah, A ; Onankpa, B ; Jamelle, R ; Junejo, D ; Faiz, N ; Gul, F ; Sherin, A ; Bangash, K ; Mahmud, G ; Masud, K ; Tasneem, N ; Gassama, S ; Soyei, A ; Agarwal, P ; Rajadurai, V ; Pirani, N ; Delport, S ; Macdonald, P ; Mokhondo, R ; Pattinson, R ; Zondo, M ; Adhikari, M ; Mnguni, N ; Moodley, J ; Carstens, M ; Kirsten, G ; Steyn, W ; van Zyl, J ; Helwig, A ; Jacobson, S-L ; Panosche, R ; Hammond, E ; Masanganise, L (WILEY, 2007-03-01)
    OBJECTIVE: The aim of this study was to assess long-term effects for women following the use of magnesium sulphate for pre-eclampsia. DESIGN: Assessment at 2-3 years after delivery for women recruited to the Magpie Trial (recruitment in 1998-2001, ISRCTN 86938761), which compared magnesium sulphate with placebo for pre-eclampsia. SETTING: Follow up after discharge from hospital at 125 centres in 19 countries across five continents. POPULATION: A total of 7927 women were randomised at the follow-up centres. Of these women, 2544 were not included for logistic reasons and 601 excluded (109 at a centre where <20% of women were contacted, 466 discharged without a surviving child and 26 opted out). Therefore, 4782 women were selected for follow-up, of whom 3375 (71%) were traced. METHODS: Questionnaire assessment was administered largely by post or in a dedicated clinic. Interview assessment of selected women was performed. Main outcome measures Death or serious morbidity potentially related to pre-eclampsia at follow up, other morbidity and use of health service resources. RESULTS: Median time from delivery to follow up was 26 months (interquartile range 19-36). Fifty-eight of 1650 (3.5%) women allocated magnesium sulphate died or had serious morbidity potentially related to pre-eclampsia compared with 72 of 1725 (4.2%) women allocated placebo (relative risk 0.84, 95% CI 0.60-1.18). CONCLUSIONS: The reduction in the risk of eclampsia following prophylaxis with magnesium sulphate was not associated with an excess of death or disability for the women after 2 years.
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    Public and/or private health care: tuberculosis patients' perspectives in Myanmar.
    Saw, S ; Manderson, L ; Bandyopadhyay, M ; Sein, TT ; Mon, MM ; Maung, W (Springer Science and Business Media LLC, 2009-07-28)
    BACKGROUND: Tuberculosis is a major public health problem in Myanmar as in other developing countries. About 73% of TB patients seek care at private general practitioners' clinics before presenting to the public TB centre, raising questions about how best to prevent transmission and maintain treatment regimens. METHOD: The study was conducted in two townships in Yangon Division in Myanmar in 2004, and examined treatment seeking behaviour of TB patients and their views towards public and private health care services. This was an exploratory descriptive study. Both quantitative and qualitative research methods were employed in data collection from TB patients, health care professionals, and members of various agencies involved in TB Control Programme. RESULTS: A considerable delay was found between the onset of symptoms of TB and seeking treatment (five days - two months). General practitioners were the first point of contact in all cases. Old TB patients influenced the treatment seeking behaviour and choice of treatment clinics of new TB patients. Most patients viewed the public health sector as a place to obtain free treatment and the private sector as a fee-paying, convenient and better place to seek treatment. CONCLUSION: The involvement of private general practitioners is crucial for effective TB control in Myanmar. The selection of GPs for partnership with the public sector is vital to the success of public-private partnership in controlling TB.
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    Policy on infant formula industry funding, support or sponsorship of articles submitted for publication.
    Beasley, A ; Amir, LH (Springer Science and Business Media LLC, 2007-03-06)
    Despite current scientific evidence that artificial feeding is a harmful practice, unquestioned acceptance of breastfeeding as the normal or "default" method of infant feeding remains elusive in the industrialised world. Throughout the developing world the profound consequences of the aggressive marketing strategies of the infant formula industry since the end of the Second World War is well known. A key objective of the International Breastfeeding Journal is to promote breastfeeding through addressing issues that encourage breastfeeding initiation, duration and effective management. Informing this aim is the recognition of artificial feeding as a harmful practice that places infant health at risk. From this perspective it would be unethical for this journal to accept for publication any manuscript that has received funding, sponsorship or any other means of support from infant formula manufacturers. This stance is consistent with the journal's aim of supporting, protecting and promoting breastfeeding. It will also contribute to the promotion of a breastfeeding culture.
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    Infant feeding, poverty and human development.
    Beasley, A ; Amir, LH (Springer Science and Business Media LLC, 2007-10-22)
    The relationship between poverty and human development touches on a central aim of the International Breastfeeding Journal's editorial policy which is to support and protect the health and wellbeing of all infants through the promotion of breastfeeding. It is proposed that exclusive breastfeeding for 6 months, followed by continued breastfeeding to 12 months, could prevent 1,301,000 deaths or 13% of all child deaths under 5 years in a hypothetical year. Although there is a conventional wisdom that poverty 'protects' breastfeeding in developing countries, poverty actually threatens breastfeeding, both directly and indirectly. In the light of increasingly aggressive marketing behaviour of the infant formula manufacturers and the need to protect the breastfeeding rights of working women, urgent action is required to ensure the principles and aim of the International Code of Breastmilk Substitutes, and subsequent relevant resolutions of the World Health Assembly, are implemented. If global disparities in infant health and development are to be significantly reduced, gender inequities associated with reduced access to education and inadequate nutrition for girls need to be addressed. Improving women's physical and mental health will lead to better developmental outcomes for their children.
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    Health professionals' advice for breastfeeding problems: not good enough!
    Amir, LH ; Ingram, J (Springer Science and Business Media LLC, 2008-09-11)
    Jane Scott and colleagues have recently published a paper in the International Breastfeeding Journal showing that health professionals are still giving harmful advice to women with mastitis. We see the management of mastitis as an illustration of health professionals' management of wider breastfeeding issues. If health professionals don't know how to manage this common problem, how can they be expected to manage less common conditions such as a breast abscess or nipple/breast candidiasis? There is an urgent need for more clinical research into breastfeeding problems and to improve the education of health professionals to enable them to promote breastfeeding and support breastfeeding women.
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    Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device
    Carey, M ; Slack, M ; Higgs, P ; Wynn-Williams, M ; Cornish, A (WILEY, 2008-02-01)
    OBJECTIVES: To describe a new surgical procedure for pelvic organ prolapse using mesh and a vaginal support device (VSD) and to report the results of surgery. DESIGN: A prospective observational study. SETTING: Two tertiary referral Urogynaecology practices. POPULATION: Ninety-five women with International Continence Society pelvic organ prolapse quantification stage 2 or more pelvic organ prolapse who underwent vaginal surgery using mesh augmentation and a VSD. METHODS: Surgery involved a vaginal approach with mesh reinforcement and placement of a VSD for 4 weeks. At 6 and 12 months, women were examined for prolapse recurrence, and visual analogue scales for satisfaction were completed. Women completed quality-of-life (QOL) questionnaires preoperatively and at 6 and 12 months. MAIN OUTCOME MEASURES: Objective success of surgery at 6 and 12 months following surgery. Secondary outcomes were subjective success, complications, QOL outcomes and patients' satisfaction. RESULTS: Objective success rate was 92 and 85% at 6 and 12 months, respectively. Subjective success rate was 91 and 87% at 6 and 12 months, respectively. New prolapse in nonrepaired compartments accounted for 7 of 12 (58%) failures at 12 months. Two of 4 mesh exposures required surgery. Sexual dysfunction was reported by 58% of sexually active women preoperatively and 23% at 12 months. QOL scores significantly improved at 12 months compared with baseline (P < 0.0001). CONCLUSION: Vaginal surgery using mesh and a VSD is an effective procedure for pelvic organ prolapse. However, further studies are required to establish the role of the surgery described in this study.
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    Role of androgens, progestins and tibolone in the treatment of menopausal symptoms: a review of the clinical evidence
    Garefalakis, M ; Hickey, M (DOVE MEDICAL PRESS LTD, 2008-01-01)
    Estrogen-containing hormone therapy (HT) is the most widely prescribed and well-established treatment for menopausal symptoms. High quality evidence confirms that estrogen effectively treats hot flushes, night sweats and vaginal dryness. Progestins are combined with estrogen to prevent endometrial hyperplasia and are sometimes used alone for hot flushes, but are less effective than estrogen for this purpose. Data are conflicting regarding the role of androgens for improving libido and well-being. The synthetic steroid tibolone is widely used in Europe and Australasia and effectively treats hot flushes and vaginal dryness. Tibolone may improve libido more effectively than estrogen containing HT in some women. We summarize the data from studies addressing the efficacy, benefits, and risks of androgens, progestins and tibolone in the treatment of menopausal symptoms.
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    Validating genetic risk associations for ovarian cancer through the international Ovarian Cancer Association Consortium
    Pearce, CL ; Near, AM ; Van Den Berg, DJ ; Ramus, SJ ; Gentry-Maharaj, A ; Menon, U ; Gayther, SA ; Anderson, AR ; Edlund, CK ; Wu, AH ; Chen, X ; Beesley, J ; Webb, PM ; Holt, SK ; Chen, C ; Doherty, JA ; Rossing, MA ; Whittemore, AS ; McGuire, V ; DiCioccio, RA ; Goodman, MT ; Lurie, G ; Carney, ME ; Wilkens, LR ; Ness, RB ; Moysich, KB ; Edwards, R ; Jennison, E ; Kjaer, SK ; Hogdall, E ; Hogdall, CK ; Goode, EL ; Sellers, TA ; Vierkant, RA ; Cunningham, JC ; Schildkraut, JM ; Berchuck, A ; Moorman, PG ; Iversen, ES ; Cramer, DW ; Terry, KL ; Vitonis, AF ; Titus-Ernstoff, L ; Song, H ; Pharoah, PDP ; Spurdle, AB ; Anton-Culver, H ; Ziogas, A ; Brewster, W ; Galitovskiy, V ; Chenevix-Trench, G (NATURE PUBLISHING GROUP, 2009-01-22)
    The search for genetic variants associated with ovarian cancer risk has focused on pathways including sex steroid hormones, DNA repair, and cell cycle control. The Ovarian Cancer Association Consortium (OCAC) identified 10 single-nucleotide polymorphisms (SNPs) in genes in these pathways, which had been genotyped by Consortium members and a pooled analysis of these data was conducted. Three of the 10 SNPs showed evidence of an association with ovarian cancer at P< or =0.10 in a log-additive model: rs2740574 in CYP3A4 (P=0.011), rs1805386 in LIG4 (P=0.007), and rs3218536 in XRCC2 (P=0.095). Additional genotyping in other OCAC studies was undertaken and only the variant in CYP3A4, rs2740574, continued to show an association in the replication data among homozygous carriers: OR(homozygous(hom))=2.50 (95% CI 0.54-11.57, P=0.24) with 1406 cases and 2827 controls. Overall, in the combined data the odds ratio was 2.81 among carriers of two copies of the minor allele (95% CI 1.20-6.56, P=0.017, p(het) across studies=0.42) with 1969 cases and 3491 controls. There was no association among heterozygous carriers. CYP3A4 encodes a key enzyme in oestrogen metabolism and our finding between rs2740574 and risk of ovarian cancer suggests that this pathway may be involved in ovarian carcinogenesis. Additional follow-up is warranted.