Obstetrics & Gynaecology

Perinatal Trials 

The Perinatal Trials group aims to evaluate important treatment interventions in pregnancy using the best quality evidence. 

 

--Professor Jim Thornton, Head of Perinatal Trials

 

Cord team

 

Research issues

Interventions in pregnancy have the potential to do harm as well as good. Our group conducts high quality evaluations to contribute to setting obstetrics and midwifery on a firm evidence base.

What we are doing about...

1. Timing of delivery

This is the single most important intervention administered by obstetricians. It is very commonly used, and has the potential to save lives and prevent serious morbidity. However, it also has the potential to cause great harm.

Our group has for many years conducted trials comparing the effect of immediate with delayed delivery when there is clinical uncertainty, notably in the field of pre-term fetal growth restriction, fetal growth restriction at term, obstetric cholestasis, and fetal gastroschisis.

2. Timing of cord clamping

Immediate clamping of the umbilical cord at delivery was introduced almost universally as part of the active management of the third stage of labour in the 1960s but has never been properly evaluated.

3. Smoking in pregnancy

This is hugely harmful. Our group conducts trials and other studies into the effect of both behavioural and pharmacological interventions to encourage smoking cessation in pregnancy.  

More about Smoking in Pregnancy research 

Current projects

Outcomes

Key papers

Duley L, Dorling J, Pushpa-Rajah A, Oddie SJ, Yoxall CW, Schoonakker B, Bradshaw L, Mitchell EJ, Fawke JA; Cord Pilot Trial Collaborative Group. (2018) Randomised trial of cord clamping and initial stabilisation at very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F6-F14.

Walker KW, Bugg GJ, Macpherson MBM, Carol McCormick C, Grace N, Wildsmith C, Bradshaw L, Smith GCS, Thornton JG on behalf of the 35/39 trial group. Randomized Trial of Labor Induction in Women 35 Years of Age or Older. N Engl J Med. 2016 Mar 3;374(9):813-22. doi: 10.1056/NEJMoa1509117.

Chappell L, Chambers J, Thornton JG, Williamson C (2018) Does ursodeoxycholic acid improve perinatal outcomes in women with intrahepatic cholestasis of pregnancy?  BMJ Feb 1;360:k104. doi: 10.1136/bmj.k104.

Malin GL, Bugg GJ, Thornton J, Taylor MA, Grauwen N, Devlieger R, Kardel KR, Kubli M, Tranmer JE, Jones NW. (2016) Does oral carbohydrate supplementation improve labour outcome? A systematic review and individual patient data meta-analysis. BJOG. Mar;123(4):510-7. doi: 10.1111/1471-0528.13728.

 

Published trials

Trials evaluating the effect of timed delivery in pregnancy

Professor Thornton has conducted a number of trials evaluating the effect of timed delivery in pregnancy.

  • The GRIT Study Group (director JGT) (2004) Infant wellbeing at 2 years of age in the Growth Restriction Intervention trial (GRIT): a multicentred randomised controlled trial. Lancet 364:513-519.
  • Logghe HL, Mason GC, Thornton JG, Stringer MD. A randomized controlled trial of elective preterm delivery of fetuses with gastroschisis. J Pediatr Surg. 2005 Nov;40(11):1726-31.
  • Walker D-M, Marlow N, Upstone, L, Gross, H. Hornbuckle J, Vail A, Wolke D, Thornton JG on behalf of the GRIT Study Group (2011) The Growth Restriction Intervention Trial (GRIT): Long-term outcomes in a randomised trial of timing of delivery in fetal growth restriction. Am J Obstet Gynecol 204(1):341-9.
  • Boers K, Bijlenga D, Vijgen S, van der Post J, Bekedam D, Kwee A, van der Salm P, van Pampus M, Spaanderman M, de Boer K, Bremer H, Duvekot J, Hasaart T, Delemarre F, Bloemenkamp K, van Meir C, Willekes C, Wijnen E, Rijken M, le Cessie S, Roumen F, Thornton JG, van Lith J, Mol BW, Scherjon S (2011) Induction versus expectant monitoring for intrauterine growth restriction at term (the DIGITAT trial). Br Med J 342: 35
 

World’s largest trial of the effect of ursodeoxycholic acid for treating obstetric cholestasisis

Professor Thornton led the team that recently conducted world’s largest trial of the effect of ursodeoxycholic acid for treating obstetric cholestasis. This factorial trial also evaluated the effect of timed delivery.

  • Chappell LC, Gurung V, Seed PT, Chambers J, Williamson C, Thornton JG on behalf of the PITCH Study Consortium. (2012) Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semi-factorial randomised clinical trial. BMJ 2012; 344 doi: 10.1136/bmj.e3799 (Published 13 June 2012)
 

Cochrane reviews on the effects of important interventions in pregnancy

  • Bugg GJ, Siddique F, Thornton JG (2011) Oxytocin versus no treatment or delayed treatment for slow progress in the first stage of spontaneous labour’ The Cochrane Library June module Issue 7, 2011 (published 6 July 2011)
  • Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database of Systematic Reviews 2012, Issue 8. Art. No.: CD003248. DOI: 10.1002/14651858.CD003248.pub3
 

World’s largest trial on nicotine patches in pregnancy

Professor Tim Coleman led the team that recently conducted the world’s largest trial on nicotine patches in pregnancy.

  • Coleman T, Cooper S, Thornton JG, Grainge MJ, Watts K, John Britton J, Lewis S for the SNAP Trial Team (2012) A randomized trial of nicotine replacement therapy patches in pregnancy. New Engl J Med. 366:808-818
 

Placenta transfusion trial

Professor Duley led the team which measured the timing and amount of placental transfusion precisely

  •  Farrar D, Airey R, Law GR, Tuffnell D, Cattle B, Duley L. Measuring placental transfusion for term births: weighing babies with cord intact. BJOG. 2011 Jan;118(1):70-5. doi: 10.1111/j.1471-0528.2010.02781.x. Epub 2010 Nov 18. PMID: 21083868 [PubMed - indexed for MEDLINE]
 

Eclampsia and MAGPIE

Professor Duley led the teams which conducted the Eclampsia and MAGPIE trials

  • Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. PMID: 12057549 [PubMed - indexed for MEDLINE]
  • The Eclampsia Trial Collaborative Group Which anticonvulsant for women with eclampsia? Evidence from the Collaborative Eclampsia Trial. Lancet, 345 (1995), pp. 1455–1463
 

 

 

Contact

Email  Jim Thornton

 

 

Links

Nottingham Clinical Trials Unit

 

 

 

 

Obstetrics & Gynaecology

School of Medicine
The University of Nottingham
Queen's Medical Centre, D Floor, East Block
Nottingham, NG7 2UH


telephone: +44 (0) 115 823 1000
email:anne.whitchurch@nottingham.ac.uk