دورية أكاديمية
Does progesterone prophylaxis to prevent preterm labour improve outcome?:A randomised double-blind placebo-controlled trial (OPPTIMUM)
| العنوان: | Does progesterone prophylaxis to prevent preterm labour improve outcome?:A randomised double-blind placebo-controlled trial (OPPTIMUM) |
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| المؤلفون: | Norman, Jane E, Marlow, Neil, Messow, Claudia-Martina, Shennan, Andrew, Bennett, Philip R, Thornton, Steven, Robson, Stephen C, McConnachie, Alex, Petrou, Stavros, Sebire, Neil J, Lavender, Tina, Whyte, Sonia, Norrie, John |
| المصدر: | Norman , J E , Marlow , N , Messow , C-M , Shennan , A , Bennett , P R , Thornton , S , Robson , S C , McConnachie , A , Petrou , S , Sebire , N J , Lavender , T , Whyte , S & Norrie , J 2018 , ' Does progesterone prophylaxis to prevent preterm labour improve outcome? A randomised double-blind placebo-controlled trial (OPPTIMUM) ' , Health Technology Assessment , vol. 22 , no. 35 , pp. 1-304 . https://doi.org/10.3310/hta22350Test |
| سنة النشر: | 2018 |
| المجموعة: | University of Bristol: Bristol Reserach |
| مصطلحات موضوعية: | Administration, Intravaginal, Bronchopulmonary Dysplasia/prevention & control, Double-Blind Method, Europe, Female, Fibronectins/blood, Gestational Age, Humans, Obstetric Labor, Premature/prevention & control, Perinatal Death/prevention & control, Pregnancy, Pregnancy Trimester, Third, Premature Birth/prevention & control, Progesterone/administration & dosage |
| الوصف: | BACKGROUND: Progesterone prophylaxis is widely used to prevent preterm birth but is not licensed and there is little information on long-term outcome. OBJECTIVE: To determine the effect of progesterone prophylaxis in women at high risk of preterm birth on obstetric, neonatal and childhood outcomes. DESIGN: Double-blind, randomised placebo-controlled trial. SETTING: Obstetric units in the UK and Europe between February 2009 and April 2013. PARTICIPANTS: Women with a singleton pregnancy who are at high risk of preterm birth because of either a positive fibronectin test or a negative fibronectin test, and either previous spontaneous birth at ≤ 34 weeks+0 of gestation or a cervical length of ≤ 25 mm. INTERVENTIONS: Fibronectin test at 18+0 to 23+0 weeks of pregnancy to determine risk of preterm birth. Eligible women were allocated (using a web-based randomisation portal) to 200 mg of progesterone or placebo, taken vaginally daily from 22+0 to 24+0 until 34+0 weeks' gestation. Participants, caregivers and those assessing the outcomes were blinded to group assignment until data collection was complete. MAIN OUTCOME MEASURES: There were three primary outcomes, as follows: (1) obstetric - fetal death or delivery before 34+0 weeks' gestation; (2) neonatal - a composite of death, brain injury on ultrasound scan (according to specific criteria in the protocol) and bronchopulmonary dysplasia; and (3) childhood - the Bayley-III cognitive composite score at 22-26 months of age. RESULTS: In total, 96 out of 600 (16%) women in the progesterone group and 108 out of 597 (18%) women in the placebo group had the primary obstetric outcome [odds ratio (OR) 0.86, 95% confidence interval (CI) 0.61 to 1.22]. Forty-six out of 589 (8%) babies of women in the progesterone group and 62 out of 587 (11%) babies of women in the placebo group experienced the primary neonatal outcome [OR 0.72, 95% CI 0.44 to 1.17]. The mean Bayley-III cognitive composite score of the children at 2 years of age was 97.3 points [standard deviation (SD) 17.9 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.3310/hta22350 |
| الإتاحة: | https://doi.org/10.3310/hta22350Test https://hdl.handle.net/1983/1463a5f3-ba72-42c6-b60f-d0fd54ad2fbaTest https://research-information.bris.ac.uk/en/publications/1463a5f3-ba72-42c6-b60f-d0fd54ad2fbaTest |
| حقوق: | info:eu-repo/semantics/restrictedAccess |
| رقم الانضمام: | edsbas.2242C2D0 |
| قاعدة البيانات: | BASE |
| DOI: | 10.3310/hta22350 |
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