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  1. Article ; Online: Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes

    Anna Davies / Erik Lenguerrand / Eleanor Scott / Rebecca Kandiyali / Isabelle Douek / Jane Norman / Abi Loose / Lynn Sawyer / Laura Timlin / Christy Burden

    Pilot and Feasibility Studies, Vol 9, Iss 1, Pp 1-

    the RECOGNISE study

    2023  Volume 14

    Abstract: Abstract Background Incidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia, and pre-term delivery. Optimum glycaemic control can reduce these adverse perinatal ... ...

    Abstract Abstract Background Incidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia, and pre-term delivery. Optimum glycaemic control can reduce these adverse perinatal outcomes. Continuous glucose monitoring (CGM) informs users about interstitial glucose levels allowing early detection of glycaemic excursions and pharmacological or behavioural intervention. Few adequately powered RCTs to evaluate the impact of using CGM in women with GDM on perinatal outcomes have been undertaken. We aim to establish the feasibility of a multi-site RCT to evaluate the clinical- and cost-effectiveness of an intermittently scanned continuous glucose monitor (isCGM) compared with self-monitored blood glucose (SMBG) in women with GDM for reducing fetal macrosomia and improving maternal and fetal outcomes. We will evaluate recruitment and retention rates, adherence to device requirements, adequacy of data capture and acceptability of trial design and isCGM devices. Methods Open-label multicentre randomised controlled feasibility trial. Inclusion criteria: pregnant women, singleton pregnancy, recent diagnosis of GDM (within 14 days of commencing medication, up to 34 weeks gestation) prescribed metformin and/or insulin. Women will be consecutively recruited and randomised to isCGM (FreestyleLibre2) or SMBG. At every antenatal visit, glucose measurements will be evaluated. The SMBG group will use blinded isCGM for 14 days at baseline (~ 12–32 weeks) and ~ 34–36 weeks. The primary outcome is the recruitment rate and absolute number of women participating. Clinical assessments of maternal and fetal/infant health will be undertaken at baseline, birth, up to ~ 13 weeks post-natal. Psychological, behavioural and health economic measures will be assessed at baseline and ~ 34–36 weeks gestation. Qualitative interviews will be undertaken with study decliners, participants, and professionals to explore trial acceptability, of using isCGM and SMBG. Discussion ...
    Keywords Gestational diabetes ; Continuous glucose monitoring ; Feasibility study ; Large for gestational age ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2023-07-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: C-STICH

    Fidan Israfil-Bayli / Victoria Hodgetts Morton / Catherine A. Hewitt / Andrew K. Ewer / Jim Gray / Jane Norman / Christoph Lees / Nigel A. B. Simpson / Andrew Shennan / Konstantinos Tryposkiadis / Max Hughes / Jane Daniels / Peter Brocklehurst / Katie Morris / Lee Middleton / Philip Toozs-Hobson

    Trials, Vol 22, Iss 1, Pp 1-

    Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes—a multicentre randomised controlled trial

    2021  Volume 14

    Abstract: Abstract Background Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the ... ...

    Abstract Abstract Background Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. Methods A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials. ...
    Keywords Obstetrics and gynaecology ; Preterm birth ; Cervical cerclage ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2021-09-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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  3. Article ; Online: Oral morphine analgesia for preventing pain during invasive procedures in non-ventilated premature infants in hospital

    Vaneesha Monk / Fiona Moultrie / Caroline Hartley / Amy Hoskin / Gabrielle Green / Jennifer L Bell / Caz Stokes / Ed Juszczak / Jane Norman / Richard Rogers / Chetan Patel / Eleri Adams / Rebeccah Slater

    Efficacy and Mechanism Evaluation, Vol 6, Iss

    the Poppi RCT

    2019  Volume 9

    Abstract: Background: Identifying better pain management strategies for painful procedures performed in neonatal care is a clinical priority. Retinopathy of prematurity screening and heel-lance blood tests are essential clinical procedures, but adequate pain ... ...

    Abstract Background: Identifying better pain management strategies for painful procedures performed in neonatal care is a clinical priority. Retinopathy of prematurity screening and heel-lance blood tests are essential clinical procedures, but adequate pain relief is not currently provided because of a lack of evidence-based analgesia. Morphine provides effective analgesia in older children and adults, but efficacy in infants is controversial. Morphine is, however, commonly used intravenously for sedation in ventilated infants. Objective: The primary objective was to investigate whether or not a single 100 µg/kg morphine sulphate dose administered orally prior to painful clinical procedures provides effective analgesia. Design: Single-centre, prospective, randomised controlled trial. Setting: John Radcliffe Hospital, Oxford, UK. Participants: Thirty-one infants of 34–42 weeks’ gestational age, requiring a heel lance and retinopathy of prematurity screening on the same test occasion. Interventions: The study interventions were 100 µg/kg of oral morphine sulphate (intervention arm) or placebo (control arm) 1 hour before the clinically required procedures. Main outcome measures: There were two co-primary outcomes: Premature Infant Pain Profile-Revised score (a higher score implies more nociceptive processing) during the 30-second period after retinopathy of prematurity screening, and the magnitude of noxious-evoked brain activity (a higher activity implies more nociceptive processing) following the heel lance. Physiological stability and safety were secondary outcomes. Results: After 31 participants were randomised (30 studied and one withdrew), the predefined safety stopping boundary was passed as 3 of the 15 infants who received morphine had apnoeas requiring resuscitation with non-invasive positive-pressure ventilation in the 24 hours after drug administration, compared with 0 of the 15 infants who received placebo [difference in proportion 0.2, 80% confidence interval (adjusted to allow for planned multiple analyses) ...
    Keywords infant ; newborn ; premature ; preterm ; morphine ; heel lance ; retinopathy of prematurity ; pain management ; analgesia ; pain ; reflex ; apnoea ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2019-08-01T00:00:00Z
    Publisher NIHR Journals Library
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: C-STICH2

    Victoria Hodgetts-Morton / Catherine A. Hewitt / Laura Jones / Lisa Leighton / Nicole Pilarski / Eleanor Molloy / Kim Hinshaw / Jane Norman / Jason Waugh / Sarah Stock / Jim Thornton / Philip Toozs-Hobson / Tracey Johnston / Arri Coomarasamy / Shakila Thangaratinam / Ben Mol / Eva Pajkrt / Neil Marlow / Tracy Roberts /
    Lee Middleton / Peter Brocklehurst / Katie Morris

    Trials, Vol 22, Iss 1, Pp 1-

    emergency cervical cerclage to prevent miscarriage and preterm birth—study protocol for a randomised controlled trial

    2021  Volume 11

    Abstract: Abstract Background Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of ...

    Abstract Abstract Background Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of cerclage are less certain. A randomised control trial is needed to accurately assess the effectiveness of ECC in preventing pregnancy loss compared to an expectant approach. Methods C-STICH2 is a multicentre randomised controlled trial in which women presenting with cervical dilatation and unruptured exposed membranes at 16 + 0 to 27 + 6 weeks gestation are randomised to ECC or expectant management. Trial design includes 18 month internal pilot with embedded qualitative process evaluation, minimal data set and a within-trial health economic analysis. Inclusion criteria are ≥16 years, singleton pregnancy, exposed membranes at the external os, gestation 16 + 0–27 + 6 weeks, and informed consent. Exclusion criteria are contraindication to cerclage, cerclage in situ or previous cerclage in this pregnancy. Randomisation occurs via an online service in a 1:1 ratio, using a minimisation algorithm to reduce chance imbalances in key prognostic variables (site, gestation and dilatation). Primary outcome is pregnancy loss; a composite including miscarriage, termination of pregnancy and perinatal mortality defined as stillbirth and neonatal death in the first week of life. Secondary outcomes include all core outcomes for PTB. Two-year development outcomes will be assessed using general health and Parent Report of Children’s Abilities-Revised (PARCA-R) questionnaires. Intended sample size is 260 participants (130 each arm) based on 60% rate of pregnancy loss in the expectant management arm and 40% in the ECC arm, with 90% power and alpha 0.05. Analysis will be by intention-to-treat. Discussion To date there has been one small trial of ECC in 23 participants which included twin and singleton pregnancies. This small trial along with the largest observational study (n = 161) ...
    Keywords Miscarriage ; Preterm birth ; Cervical cerclage ; Randomised controlled trial ; Economic evaluation ; Qualitative process evaluation ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2021-08-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

    More links

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

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