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All Outputs (29)

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study (2023)
Journal Article
Kai, J., Dutton, B., Vinogradova, Y., Hilken, N., Gupta, J., & Daniels, J. (2023). Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study. Health Technology Assessment, 27(17), https://doi.org/10.3310/jhsw0174

Background: Heavy menstrual bleeding is a common problem that can significantly affect women’s lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. Objectives... Read More about Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study.

Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review (2023)
Journal Article
Odubamowo, K., Garcia, M., Muriithi, F., Ogollah, R., Daniels, J. P., & Walker, K. F. (2023). Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review. European Journal of Obstetrics and Gynecology and Reproductive Biology, 286, 95-101. https://doi.org/10.1016/j.ejogrb.2023.05.027

Background Testing for group B streptococcus (GBS) requires a vaginal-rectal swab in late pregnancy. Objective A systematic review of the test accuracy of a self-collected swab compared with a health-care professional collected swab in the diagnos... Read More about Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review.

Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial (2023)
Journal Article
Whitaker, L. H. R., Middleton, L. J., Daniels, J. P., Williams, A. R. W., Priest, L., Odedra, S., …Critchley, H. O. D. (2023). Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial. eClinicalMedicine, 60, Article 101995. https://doi.org/10.1016/j.eclinm.2023.101995

Background: Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. Ulipristal acetate is prescribed to treat symptoms associated with uterine fibroids. We compared the effectiveness of ulipristal acetate and the le... Read More about Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial.

Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study (2023)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Walker, K. F., Daniels, J., Moore, S., …Downe, S. (2023). Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study. BMC Pregnancy and Childbirth, 23, Article 339. https://doi.org/10.1186/s12884-023-05651-0

Background: 20–25% pregnant women in the UK carry group B streptococcus (GBS) which, if left undetected, is transmitted from pregnant mothers to their babies during birth in 36% of cases. This transmission leads to early onset GBS infection (EOGBS) i... Read More about Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study.

Systematic review of the effectiveness of remifentanil in term breech pregnancies undergoing external cephalic version (2023)
Journal Article
Lomas, S., Minton, Z., & Daniels, J. P. (2023). Systematic review of the effectiveness of remifentanil in term breech pregnancies undergoing external cephalic version. International Journal of Obstetric Anesthesia, 54, Article 103649. https://doi.org/10.1016/j.ijoa.2023.103649

Background: External cephalic version (ECV) is a moderately painful procedure used to turn a fetus from a non-vertex to cephalic position. This systematic review and meta-analysis compared intravenous remifentanil with other analgesia or no analgesia... Read More about Systematic review of the effectiveness of remifentanil in term breech pregnancies undergoing external cephalic version.

Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial. (2023)
Journal Article
Horne, A. W., Tong, S., Moakes, C. A., Middleton, L. J., Duncan, W. C., Mol, B. W., …Daniels, J. P. (2023). Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet, 401(10377), 655-663. https://doi.org/10.1016/S0140-6736%2822%2902478-3

Background Tubal ectopic pregnancies can cause substantial morbidity or even death. Current treatment is with methotrexate or surgery. Methotrexate treatment fails in approximately 30% of women who subsequently require rescue surgery. Gefitinib, an... Read More about Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial..

Medical treatment for heavy menstrual bleeding in primary care: 10-year data from the ECLIPSE trial (2022)
Journal Article
Kai, J., Dutton, B., Vinogradova, Y., Hilken, N., Gupta, J., & Daniels, J. (2022). Medical treatment for heavy menstrual bleeding in primary care: 10-year data from the ECLIPSE trial. British Journal of General Practice, 72(725), e857-e864. https://doi.org/10.3399/bjgp.2022.0260

Background Heavy menstrual bleeding (HMB) is a common problem that can significantly affect women's lives. There is a lack of evidence on long-term outcomes after seeking treatment. Aim To assess continuation rates of medical treatments and rates of... Read More about Medical treatment for heavy menstrual bleeding in primary care: 10-year data from the ECLIPSE trial.

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial (2022)
Journal Article
Hodgetts Morton, V., Toozs-Hobson, P., Moakes, C. A., Middleton, L., Daniels, J., Simpson, N. A., …Morris, R. K. (2022). Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial. Lancet, 400(10361), 1426-1436. https://doi.org/10.1016/S0140-6736%2822%2901808-6

Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture th... Read More about Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.

A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert (2022)
Journal Article
Gupta, J. K., Maher, A., Stubbs, C., Brocklehurst, P., Daniels, J. P., & Hardy, P. (2022). A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert. American Journal of Obstetrics and Gynecology, 4(4), Article 100628. https://doi.org/10.1016/j.ajogmf.2022.100628

BACKGROUND: Induction of labor is a commonly performed obstetrical intervention. Vaginal prostaglandin E2 (dinoprostone) is a first-choice agent. Mechanical methods of induction are slower in achieving cervical ripening but have a lower risk of adver... Read More about A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert.

A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT (2022)
Journal Article
Daniels, J., Dixon, E. F., Gill, A., Bishop, J., D'Amico, M., Ahmed, K., …Thangaratinam, S. (2022). A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT. Health Technology Assessment, 26(12), 1-82. https://doi.org/10.3310/BICF1187

BACKGROUND: Mother-to-baby transmission of group B Streptococcus (Streptococcus agalactiae) is the main cause of early-onset infection. OBJECTIVES: We investigated if intrapartum antibiotic prophylaxis directed by a rapid intrapartum test reduces mat... Read More about A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT.

Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study (2022)
Journal Article
Daniels, J. P., Dixon, E., Gill, A., Bishop, J., Wilks, M., Millar, M., …Collaboative Group, G. (2022). Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study. BMC Medicine, 20, Article 9. https://doi.org/10.1186/s12916-021-02202-2

Background: Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test... Read More about Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study.

Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT (2022)
Journal Article
Armstrong-Buisseret, L., Brittain, C., Kai, J., David, M., Anstey Watkins, J., Ozolins, M., …Ross, J. D. (2022). Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT. Health Technology Assessment, 26(2), 1-170. https://doi.org/10.3310/ZZKH4176

BACKGROUND: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur. OBJECTIVES: The... Read More about Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT.

The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis (2021)
Journal Article
Haydock, R., Hepburn, T., Ross, J., Daniels, J., Brittain, C., Jackson, L., …Wilson, J. (2021). The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis. Trials, 23(1), Article 1040. https://doi.org/10.1186/s13063-022-06954-x

Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women of reproductive age, and it is estimated that up to a third of women will experience it at some point in their lives. BV produces an offensive vaginal odour a... Read More about The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis.

Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial (2021)
Journal Article
Li, T., Li, J., Yuan, L., Wu, J., Jiang, C., Daniels, J., …RAGA Study Investigators. (2021). Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial. Journal of the American Medical Association, https://doi.org/10.1001/jama.2021.22647

Importance: In adults undergoing hip fracture surgery, regional anesthesia may reduce postoperative delirium, but there is uncertainty about its effectiveness. Objective: To investigate, in older adults undergoing surgical repair for hip fracture, th... Read More about Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial.

Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study (2021)
Working Paper
Mitchell, E. J., Aluvaala, J., Bradshaw, L., Daniels, J., Kumar, A., Opira, J., …Ojha, S. Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global healt... Read More about Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study.

Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial (2021)
Journal Article
Daniels, J., Middleton, L. J., Cheed, V., McKinnon, W., Sirkeci, F., Manyonda, I., …on behalf of the FEMME Trial Collaborative Group. (2022). Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial. European Journal of Obstetrics && Gynecology and Reproductive Biology: X, 13, Article 100139. https://doi.org/10.1016/j.eurox.2021.100139

Objective: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has b... Read More about Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial.

Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya (2021)
Journal Article
Mitchell, E. J., Pallotti, P., Qureshi, Z., Daniels, J. P., Oliver, M., Were, F., …Ojha, S. (2021). Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya. BMJ Open, 11(6), Article e043802. https://doi.org/10.1136/bmjopen-2020-043802

Objectives: Prematurity is the leading cause of global neonatal and infant mortality. Many babies could survive by the provision of essential newborn care. This qualitative study was conducted in order to understand, from a family and professional pe... Read More about Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya.

Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial (2021)
Journal Article
Rana, D., Wu, O., Cheed, V., Middleton, L. J., Moss, J., Ann Lumsden, M., …The FEMME Trial Collaborative Group. (2021). Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial. BJOG: An International Journal of Obstetrics and Gynaecology, 128(11), 1793-1802. https://doi.org/10.1111/1471-0528.16781

Objectives: To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. Design: Economic evaluation alongside the FEMME randomised controlled trial. S... Read More about Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial.

Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1) (2021)
Journal Article
Whitaker, L. H., Doust, A., Stephen, J., Norrie, J., Cooper, K., Daniels, J., …Horne, A. W. (2021). Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1). Pilot and Feasibility Studies, 7(1), Article 19. https://doi.org/10.1186/s40814-020-00740-9

Background: Endometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial perito... Read More about Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1).