Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial

I. Matok, J. Umans, M. N. Feghali, Shannon Clark, S. Caritis, M. Miodovnik, Gary Hankins, D. R. Mattison, H. Nordeng, G. Koren

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

The placebo effect has not been characterised in pregnant women suffering from nausea and vomiting of pregnancy (NVP). Our aim was to characterise determinants of the placebo effect in women treated with placebo for NVP. We analysed data from a multicentre, double blind randomised controlled trial of Diclectin® (delayed release doxylamine and pyridoxine) vs placebo for the treatment of NVP. A total of 127 women in the placebo arm and 130 in the active arm provided evaluable data for this analysis. Women who chose to continue placebo on a compassionate basis (n = 41) had significantly better improvement in symptoms of NVP and higher Wellbeing scores than those who did not ask to continue compassionate use. Results were similar in the active drug arm. The request to continue compassionate use of either placebo or active drug could be predicted by greater improvement in symptoms of NVP during the trial period.

Original languageEnglish (US)
Pages (from-to)557-560
Number of pages4
JournalJournal of Obstetrics and Gynaecology
Volume33
Issue number6
DOIs
StatePublished - Aug 2013

Fingerprint

Compassionate Use Trials
Nausea
Vomiting
Placebos
Pregnancy
Placebo Effect
Doxylamine
Pyridoxine
Pharmaceutical Preparations
Pregnant Women
Randomized Controlled Trials

Keywords

  • Diclectin®
  • Epidemiology
  • Nausea and vomiting of pregnancy
  • Placebo
  • Wellbeing

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial. / Matok, I.; Umans, J.; Feghali, M. N.; Clark, Shannon; Caritis, S.; Miodovnik, M.; Hankins, Gary; Mattison, D. R.; Nordeng, H.; Koren, G.

In: Journal of Obstetrics and Gynaecology, Vol. 33, No. 6, 08.2013, p. 557-560.

Research output: Contribution to journalArticle

Matok, I. ; Umans, J. ; Feghali, M. N. ; Clark, Shannon ; Caritis, S. ; Miodovnik, M. ; Hankins, Gary ; Mattison, D. R. ; Nordeng, H. ; Koren, G. / Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial. In: Journal of Obstetrics and Gynaecology. 2013 ; Vol. 33, No. 6. pp. 557-560.
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