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Professor JANE DANIELS's Outputs (43)

Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT (2024)
Journal Article
Cooper, K. G., Bhattacharya, S., Daniels, J. P., Cheed, V., Gennard, L., Leighton, L., Pirie, D., Melyda, M., Monahan, M., Weckesser, A., Roberts, T., Denny, E., Ocansey, L., Stubbs, C., Cox, E., Jones, G., Clark, T. J., Saridogan, E., Gupta, J. K., Critchley, H. O., …Middleton, L. J. (2024). Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT. Health Technology Assessment, 28(55), 1-77. https://doi.org/10.3310/sqwy6998

Background Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option. Obje... Read More about Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT.

The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study (2024)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Moore, S., Jones, A.-M., Downe, S., Walker, K. F., & Daniels, J. (2024). The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study. Midwifery, 135, Article 104063. https://doi.org/10.1016/j.midw.2024.104063

Background: Group B streptococcus (GBS) is a bacterium carried by 20–25 % of pregnant women in the UK, which can be transmitted from pregnant women to their babies at the time of birth. Women can be tested for GBS in pregnancy using a vaginal-rectal... Read More about The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study.

Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial (2024)
Journal Article
Cooper, K. G., Bhattacharya, S., Daniels, J. P., Horne, A. W., Clark, T. J., Saridogan, E., Cheed, V., Pirie, D., Melyda, M., Monahan, M., Roberts, T. E., Cox, E., Stubbs, C., Middleton, L. J., & on behalf of the PRE-EMPT Collaborative Group. (in press). Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial. BMJ, 385, e079006. https://doi.org/10.1136/bmj-2023-079006

Objectives: To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. Design: The PRE-EMPT (preventing recurrence of endometriosis) pr... Read More about Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial.

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study (2024)
Journal Article
Mitchell, E. J., Aluvaala, J., Bradshaw, L., Daniels, J. P., Emadau, C., Muthumbi, B., Nabwera, H., Ojee, E., Opira, J., Pallotti, P., Qureshi, Z., Sigei, M., Su, Y., Swinden, R., Were, F., & Ojha, S. (2024). A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study. BMC Pediatrics, 24, Article 326. https://doi.org/10.1186/s12887-024-04778-z

Preterm birth (< 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g., temperature, heart rate, respiratory rate) are recorded, triggering action. To evaluate whe... Read More about A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study.

Metformin for endometrial hyperplasia (2024)
Journal Article
Shiwani, H., Clement, N. S., Daniels, J. P., & Atiomo, W. (2024). Metformin for endometrial hyperplasia. Cochrane Database of Systematic Reviews, 2024(5), Article CD012214. https://doi.org/10.1002/14651858.cd012214.pub3

Background
Endometrial cancer is one of the most common gynaecological cancers in the world. Rates of endometrial cancer are rising, in part because of rising obesity rates. Endometrial hyperplasia is a precancerous condition in women that can lead... Read More about Metformin for endometrial hyperplasia.

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.

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)
Preprint / 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.

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.

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).

Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya (2020)
Journal Article
Mitchell, E., Qureshi, Z., Were, F., Daniels, J., Gwako, G., Osoti, A., …Ojha, S. (2020). Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya. BMJ Global Health, 10(10), Article e039061. https://doi.org/10.1136/bmjopen-2020-039061

Introduction: Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month of life are due to prematurity and the neonatal mort... Read More about Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya.

Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya (2020)
Journal Article
Mitchell, E. J., Qureshi, Z., Were, F., Daniels, J., Gwako, G., Osoti, A., …Ojha, S. (2020). Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya. BMJ Open, 10(10), Article e039061. https://doi.org/10.1136/bmjopen-2020-039061

© 2020 BMJ Publishing Group. All rights reserved.
Introduction Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month o... Read More about Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya.

Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial (2020)
Journal Article
Horne, A. W., Vincent, K., Hewitt, C. A., Middleton, L. J., Koscielniak, M., Szubert, W., …GaPP2 collaborative. (2020). Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet, 396(10255), 909-917. https://doi.org/10.1016/S0140-6736%2820%2931693-7

© 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: Chronic pelvic pain affects 2–24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in tre... Read More about Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial.

Uterine-Artery Embolization or Myomectomy for Uterine Fibroids (2020)
Journal Article
Manyonda, I., Belli, A. M., Lumsden, M. A., Moss, J., McKinnon, W., Middleton, L. J., …McPherson, K. (2020). Uterine-Artery Embolization or Myomectomy for Uterine Fibroids. New England Journal of Medicine, 383(5), 440-451. https://doi.org/10.1056/NEJMoa1914735

Copyright © 2020 Massachusetts Medical Society. BACKGROUND: Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of li... Read More about Uterine-Artery Embolization or Myomectomy for Uterine Fibroids.

Pravastatin for early‐onset preeclampsia: a randomized, blinded, placebo‐controlled trial (2019)
Journal Article
Ahmed, A., Williams, D. J., Cheed, V., Middleton, L. J., Ahmad, S., Wang, K., …StAmP trial collaborative group. (2020). Pravastatin for early‐onset preeclampsia: a randomized, blinded, placebo‐controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology, 127(4), 478-488. https://doi.org/10.1111/1471-0528.16013

Objective
Women with preeclampsia have elevated circulating levels of soluble fms‐like tyrosine kinase‐1 (sFlt‐1). Statins can reduce sFlt‐1 from cultured cells and improve pregnancy outcome in animals with a preeclampsia‐like syndrome. We investiga... Read More about Pravastatin for early‐onset preeclampsia: a randomized, blinded, placebo‐controlled trial.

Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial (2019)
Journal Article
Goranitis, I., Lissauer, D. M., Coomarasamy, A., Wilson, A., Daniels, J., Middleton, L., …Roberts, T. E. (2019). Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial. Lancet Global Health, 7(9), e1280-e1286. https://doi.org/10.1016/s2214-109x%2819%2930336-5

Background
There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarria... Read More about Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial.

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy (2019)
Journal Article
Coomarasamy, A., Devall, A. J., Cheed, V., Harb, H., Middleton, L. J., Gallos, I. D., …Jurkovic, D. (2019). A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. New England Journal of Medicine, 380(19), 1815-1824. https://doi.org/10.1056/NEJMoa1813730

© 2019 Massachusetts Medical Society.
BACKGROUND Bleeding in early pregnancy is strongly associated with pregnancy loss. Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone therapy may i... Read More about A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy.

Levothyroxine in women with thyroid peroxidase antibodies before conception (2019)
Journal Article
Dhillon-Smith, R. K., Middleton, L. J., Sunner, K. K., Cheed, V., Baker, K., Farrell-Carver, S., …Coomarasamy, A. (2019). Levothyroxine in women with thyroid peroxidase antibodies before conception. New England Journal of Medicine, 380(14), 1316-1325. https://doi.org/10.1056/nejmoa1812537

Background
Thyroid peroxidase antibodies are associated with an increased risk of miscarriage and preterm birth, even when thyroid function is normal. Small trials indicate that the use of levothyroxine could reduce the incidence of such adverse out... Read More about Levothyroxine in women with thyroid peroxidase antibodies before conception.

A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery (2019)
Journal Article
Lissauer, D., Wilson, A., Hewitt, C. A., Middleton, L., Bishop, J. R., Daniels, J., …Coomarasamy, A. (2019). A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery. New England Journal of Medicine, 380(11), 1012-1021. https://doi.org/10.1056/NEJMoa1808817

© 2019 Massachusetts Medical Society. BACKGROUND Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important co... Read More about A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.

Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial (2018)
Journal Article
Wilson, M. J., MacArthur, C., Hewitt, . C. A., Handley, K., Gao, F., Beeson, L., & Daniels, J. (2018). Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial. Lancet, 392(10148), 662-672. https://doi.org/10.1016/S0140-6736%2818%2931613-1

Background: Approximately a third of women receiving pethidine for labour pain subsequently require an epidural, which provides effective pain relief but increases the risk of instrumental delivery. Remifentanil patient controlled analgesia (PCA) in... Read More about Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial.

Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO) (2017)
Journal Article
Khan, K. S., Moore, P. A., Wilson, M. J., Hooper, R., Allard, S., Wrench, I., …Dodds, J. (2017). Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO). PLoS Medicine, 14(12), Article e1002471. https://doi.org/10.1371/journal.pmed.1002471

Background: Excessive haemorrhage at caesarean section requires donor (allogeneic) blood transfusion. Cell 34 salvage may reduce this requirement.
Methods and findings: We conducted a pragmatic randomised controlled trial (26 obstetric units; Jun... Read More about Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO).

Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care (2016)
Journal Article
Kai, J., Middleton, L., Daniels, J., Pattison, H., Tryposkiadis, K., & Gupta, J. (in press). Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care. British Journal of General Practice, 66(653), Article e861-e870. https://doi.org/10.3399/bjgp16X687577

Background: Heavy menstrual bleeding (HMB) is a common, chronic problem burdening women and health services. However long-term evidence on treatment in primary care is lacking.

Aim: To assess the effectiveness of commencing levonorgestrel intra-ut... Read More about Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care.

Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial (2016)
Journal Article
McIntosh, E., Gray, A., Daniels, J., Gill, S., Ives, N., Jenkinson, C., …on behalf of The PD SURG Collaborators Group. (2016). Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial. Movement Disorders, 31(8), 1173-1182. https://doi.org/10.1002/mds.26423

Introduction

Williams and colleagues reported that DBS surgery for patients with advanced PD improves motor function and quality of life compared to best medical therapy alone at 1 year, but with surgery‐related side effects in a minority. This ar... Read More about Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial.

Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. (2015)
Journal Article
Cooper, N. A., Clark, T. J., Middleton, L., Diwakar, L., Smith, P., Denny, E., …Thornton, J. (2015). Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. BMJ, 350, Article h1398. https://doi.org/10.1136/bmj.h1398

© BMJ Publishing Group Ltd 2015. To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy. Design Pragmatic multicentre randomised controlled noninferiority study. Setting Outpatient hysteroscopy clinics in... Read More about Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study..

Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial (2014)
Journal Article
Daniels, J., Gray, R., Ives, N., Rick, C., Patel, S., Gray, A., …Clarke, C. (2014). Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial. Lancet, 384(9949), 1196-1205. https://doi.org/10.1016/S0140-6736%2814%2960683-8

Background
Whether initial treatment for Parkinson's disease should consist of levodopa, dopamine agonists, or monoamine oxidase type B inhibitors (MAOBI) is uncertain. We aimed to establish which of these three classes of drug, as initial treatment... Read More about Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial.

Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial (2014)
Journal Article
Sanghera, S., Roberts, T. E., Barton, P., Frew, E., Daniels, J., Middleton, L., …Gupta, J. K. (2014). Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial. PLoS ONE, 9(3), Article e91891. https://doi.org/10.1371/journal.pone.0091891

Objective: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device (‘LNG-IUS’) and usual medical treatment for women with menorrhagia in primary care; and compare th... Read More about Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial (2010)
Journal Article
Williams, A., Gill, S., Varma, T., Jenkinson, C., Quinn, N., Mitchell, R., …Wheatley, K. (2010). Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial. Lancet Neurology, 9(6), 581-591. https://doi.org/10.1016/s1474-4422%2810%2970093-4