The trial was designed and completed as a cluster-randomised controlled trial where each of the 14 trial centres were randomised to either the new guideline proposed by Zhang et. al. or the control group adhering to the WHO partograph guideline. Due to the design, standard statistical methods were no longer applicable, and the trial leaders turned to the statistical resources at OUS for advise and help with the analyses.
«The statistical help we received at OECB has been invaluable. The statisticians, with their profound statistical knowledge, have entered the field of obstetrics in an impressive way. Several interdisciplinary discussions have enhanced the article.» says Rebecka Dalbye, one of the first authors.
«It has been a wonderful experience to see how we as statisticians can contribute as part of a strong and well-organised trial. The analyses were far from trivial, and we are very happy to see that the statistical solutions we chose were well received by our peer reviewers.», says Inge Christoffer Olsen on behalf of the statisticians in the trial.
The trial is an example on how a strong collaboration between dedicated and resourceful clinicians, and experienced statisticians may change clinical practice world wide.
The Lancet article:
Bernitz S, Dalbye R, Zhang J, Eggebø TM, Frøslie KF, Olsen IC, Blix E, Øian P (2018)
The frequency of intrapartum caesarean section use with the WHO partograph versus Zhang's guideline in the Labour Progression Study (LaPS): a multicentre, cluster-randomised controlled trial
Lancet (in press)
DOI 10.1016/S0140-6736(18)31991-3, PubMed 30581039