Supported Trials

Analysis & Dissemination

ARCTIC Feasibility

The efficacy and safety of two topical antiseptic solutions for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: a feasibility study

Role of the NPEU
Input into trial design and oversight (advice on randomisation, database development/management, regulatory functions and statistical analysis), data analysis. Study led by Norfolk and Norwich University Hospitals NHS Foundation Trust.

Published Protocol

  • Clarke P, Craig JV, Wain J, Tremlett C, Linsell L, Bowler U, et al. Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol. BMJ open. 2019;9(2):e028022
    http://dx.doi.org/10.1136/bmjopen-2018-028022

ePrime (MRI)

Evaluation of MR Imaging to predict neurodevelopmental impairment to preterm infants.

Role of the NPEU
Qualitative research, randomisation service, clinical database, statistical analysis and economic evaluation. Study led by Imperial College, London .

Publications

  • Edwards AD, Redshaw ME, Kennea N, Rivero-Arias O, Gonzales-Cinca N, Nongena P, et al. Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation. Arch Dis Child Fetal Neonatal Ed. 2018;103(1):F15-f21.
    http://dx.doi.org/10.1136/archdischild-2017-313102

Archive of non-NPEU trials supported by the NPEU Clinical Trials Unit

8002

System 8002 Trial: Computerised cardiotocographic interpretation of the compromised fetus during the antenatal period.

Role of the NPEU
Assisting with design of trial and data collection tools. Writing data entry program and advising on data management. Analysis of data and report writing.

Admission cardiotocography

Admission cardiotocography: a randomised controlled trial.

Role of the NPEU
Randomisation, analysis of results and co-writing of report.

Publications

CLASP

CLASP (Collaborative Low-dose Aspirin Study in Pregnancy): a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia.

Role of the NPEU
Support in co-ordinating trial.

Publications

  • The CLASP Collaborative Group. CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. Lancet. 1994;343(8898):619-29.
    http://www.ncbi.nlm.nih.gov/pubmed/7906809

EC Concerted Action Programme: Volume Expansion Trial

Multicentre trial of prophylactic volume expansion for very preterm neonates.

Role of the NPEU
Co-supervision of randomisation and study conduct.

Publications

  • Northern Neonatal Nursing Initiative Trial Group. A randomized trial comparing the effect of prophylactic intravenous fresh frozen plasma, gelatin or glucose on early mortality and morbidity in preterm babies. The Northern Neonatal Nursing Initiative [NNNI] Trial Group. Eur J Pediatr. 1996;155(7):580-8.
    http://www.ncbi.nlm.nih.gov/pubmed/8831082
  • Northern Neonatal Nursing Initiative Trial Group. Randomised trial of prophylactic early fresh-frozen plasma or gelatin or glucose in preterm babies: outcome at 2 years. Lancet. 1996;348(9022):229-32.
    http://www.ncbi.nlm.nih.gov/pubmed/8684200

ELSA

The Early Labour Support and Assessment trial.

Role of the NPEU
Trial design, randomisation, statistical analysis and report writing carried out by NPEU. The study was led by the Mother and Infant Research Unit (MIRU), University of York.

EUPHRATES

EUPHRATES trial of blood collector bag in third stage of labour.

Role of the NPEU
Advised and approved analysis plan. Checked analysis, contributed to paper.

Publications

  • Zhang WH, Deneux-Tharaux C, Brocklehurst P, Juszczak E, Joslin M, Alexander S. Effect of a collector bag for measurement of postpartum blood loss after vaginal delivery: cluster randomised trial in 13 European countries. BMJ. 2010;340:c293.
    http://www.ncbi.nlm.nih.gov/pubmed/20123835

Fish oil supplementation and pregnancy duration

Role of the NPEU
Advisory.

Publications

  • Olsen SF, Sorensen JD, Secher NJ, Hedegaard M, Henriksen TB, Hansen HS, Grant A. Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration. Lancet. 1992;339(8800):1003-7.
    http://www.ncbi.nlm.nih.gov/pubmed/1349049

GRACES

Glibenclamide and metfoRmin versus stAndard Care in gEstational diabeteS (GRACES) – a feasibility open label randomised trial

Role of the NPEU
Randomisation service, database and statistical analysis. Trial is run by the University of Edinburgh.
https://www.npeu.ox.ac.uk/graces

Publications

Hinchingbrooke Trial

The Hinchinbrooke Third Stage Randomised Controlled Trial.

Role of the NPEU
Data processing and analysis undertaken by NPEU. Collaboration with Hinchingbrooke Healthcare Trust.

Publications

  • Rogers J, Wood J, McCandlish R, Ayers S, Truesdale A, Elbourne D. Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial. Lancet. 1998;351(9104):693-9.
    http://www.ncbi.nlm.nih.gov/pubmed/9504513

INFANT

A multicentre randomised controlled trial of an intelligent system to support decision making in the management of labour using the cardiotocogram.

Role of the NPEU
Randomisation service, statistical analysis and economic evaluation. Trial website:
http://www.ucl.ac.uk/ctu/researchareas/womenshealth/infant

Publications

Published Protocol

  • Brocklehurst P, on behalf of the INFANT Collaborative Group. A study of an intelligent system to support decision making in the management of labour using the cardiotocograph - the INFANT study protocol. BMC Pregnancy Childbirth. 2016;16(1):10.

Intra-umbilical vein injection

Intra-umbilical vein injection in the management of retained placenta.

Role of the NPEU
Advisory.

Ipswich Perineal Suturing Trial

The Ipswich Childbirth Study - a randomised trial to evaluate a policy of leaving the perineal skin unsutured when repairing trauma sustained during normal vaginal delivery.

Role of the NPEU
Data processing and analysis.

Publications

  • Grant A, Gordon B, Mackrodat C, Fern E, Truesdale A, Ayers S. The Ipswich childbirth study: one year follow up of alternative methods used in perineal repair. BJOG. 2001;108(1):34-40.
    http://www.ncbi.nlm.nih.gov/pubmed/11213002
  • Gordon B, Mackrodt C, Fern E, Truesdale A, Ayers S, Grant A. The Ipswich Childbirth Study: 1. A randomised evaluation of two stage postpartum perineal repair leaving the skin unsutured. Br J Obstet Gynaecol. 1998;105(4):435-40.
    http://www.ncbi.nlm.nih.gov/pubmed/9609272
  • Mackrodt C, Gordon B, Fern E, Ayers S, Truesdale A, Grant A. The Ipswich Childbirth Study: 2. A randomised comparison of polyglactin 910 with chromic catgut for postpartum perineal repair. Br J Obstet Gynaecol. 1998;105(4):441-5.
    http://www.ncbi.nlm.nih.gov/pubmed/9609273

OCTAVE

Oxford Region Controlled Trial of Artificial Ventilation.

Role of the NPEU
Consultative.

Publications

  • OCTAVE Study Group. Multicentre randomised controlled trial of high against low frequency positive pressure ventilation. Oxford Region Controlled Trial of Artificial Ventilation OCTAVE Study Group. Arch Dis Child. 1991;66(7 Spec No):770-5.
    http://www.ncbi.nlm.nih.gov/pubmed/1863121

Oral Salbutamol in Twin Pregnancy

Prevention of premature labour in twin pregnancy using prophylactic oral salbutamol.

Role of the NPEU
Computing support.

Publications

  • Ashworth MF, Spooner SF, Verkuyl DA, Waterman R, Ashurst HM. Failure to prevent preterm labour and delivery in twin pregnancy using prophylactic oral salbutamol. Br J Obstet Gynaecol. 1990;97(10):878-82.
    http://www.ncbi.nlm.nih.gov/pubmed/2223677

Oxford Midwives Cord Clamping Study

Role of the NPEU
Advisory and computer analysis.

Publications

  • Oxford Midwives Research Group. A study of the relationship between the delivery to cord clamping interval and the time of cord separation. Midwifery. 1991;7(4):167-76.
    http://www.ncbi.nlm.nih.gov/pubmed/1779870

PHVD Trial

Randomised controlled trial of drug therapy in neonatal post-haemorrhagic ventricular dilatation.

Role of the NPEU
Trial management advice as well as additional data management and analysis undertaken at the NPEU.

Publications

  • The International PHVD Drug Trial Group. International randomised controlled trial of acetazolamide and furosemide in posthaemorrhagic ventricular dilatation in infancy. Lancet. 1998;352(9126):433-40.
    http://www.ncbi.nlm.nih.gov/pubmed/9708751

Programme of Midwifery Research (v) Trial of alternative treatments for 'late' dyspareunia following vaginal delivery

Part of the Programme of Midwifery Research on Problems in the Postnatal Period (v) Randomised controlled trial of alternative treatments for 'late' dyspareunia following vaginal delivery (Milton Keynes Dyspareunia Study)

Role of the NPEU
Advice given on trial design, conduct, analysis and reporting.

Publications

PROMMIS

Prelabour Rupture Of the Membranes and MISoprostol. A multicentre randomised trial to evaluate oral misoprostol for inductin of labour following prelabour repture of the membranes.

Role of the NPEU
Randomisation service, design and management of database, interim analyses and final analysis.

Publications

  • Bricker L, Peden H, Tomlinson AJ, Al-Hussaini TK, Idama T, Candelier C, Luckas M, Furniss H, Davies A, Kumar B, Roberts J, Alfirevic Z. Titrated low-dose vaginal and/or oral misoprostol to induce labour for prelabour membrane rupture: a randomised trial. BJOG. 2008;115(12):1503-11.
    http://www.ncbi.nlm.nih.gov/pubmed/18752586

Randomised controlled trial to compare three types of fetal scalp electrode

Fetal Scalp Electrode Trial.

Role of the NPEU
Advice given on protocol devleopment. NPEU conducted the analysis.

Publications

Social support and pregnancy outcome

Role of the NPEU
Consultative.

Publications

Southmead Suturing Trial

The Southmead perineal suture study. A randomised controlled trial of suture materials and suturing techniques for repair of perineal trauma.

Role of the NPEU
Design, data processing and analysis.

Publications

  • Mahomed K, Grant A, Ashurst H, James D. The Southmead perineal suture study. A randomized comparison of suture materials and suturing techniques for repair of perineal trauma. Br J Obstet Gynaecol. 1989;96(11):1272-80.
    http://www.ncbi.nlm.nih.gov/pubmed/2558705

Zimbabwe Trials

Randomised controlled trial to test whether a policy of admission to hospital for rest is of value in the management of women with non-proteinuric hypertension during pregnancy.

Role of the NPEU
Computing support.

Publications

  • Crowther CA, Bouwmeester AM, Ashurst HM. Does admission to hospital for bed rest prevent disease progression or improve fetal outcome in pregnancy complicated by non-proteinuric hypertension? Br J Obstet Gynaecol. 1992;99(1):13-7.
    http://www.ncbi.nlm.nih.gov/pubmed/1547164

Zimbabwe Trials

Randomised controlled trial to test whether a policy of bed rest, from 28-30 weeks gestation until delivery, lengthens the duration of gestation, improves fetal growth and decreases neonatal morbidity in twin pregnancy.

Role of the NPEU
Computing support.

Publications

  • Crowther CA, Verkuyl DA, Neilson JP, Bannerman C, Ashurst HM. The effects of hospitalization for rest on fetal growth, neonatal morbidity and length of gestation in twin pregnancy. Br J Obstet Gynaecol. 1990;97(10):872-7.
    http://www.ncbi.nlm.nih.gov/pubmed/2223676