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Obstetrics and gynaecology
Research
Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomised control trial with patient preference arm
  1. Nicola Mitchell-Jones1,2,
  2. Jessica Alice Farren2,3,4,
  3. Aurelio Tobias5,
  4. Tom Bourne2,4,
  5. Cecilia Bottomley1
  1. 1 Department of Obstetrics and Gynaecology, Chelsea and Westminster Hospital, London, UK
  2. 2 Department of Surgery and Cancer, Imperial College London, London, UK
  3. 3 Department of Obstetrics and Gynaecology, St Mary’s Hospital, Imperial College Trust, London, UK
  4. 4 Tommy’s National Centre for Miscarriage Research, Queen Charlotte’s and Chelsea Hospital, Imperial College Trust, London, UK
  5. 5 Institute of Metabolism and Systems Research (IMSR), University of Birmingham, Birmingham Women’s NHS Foundation Trust, Birmingham, UK
  1. Correspondence to Nicola Mitchell-Jones; nicola.mitchell-jones{at}chelwest.nhs.uk

Abstract

Objective To determine whether ambulatory (outpatient (OP)) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care.

Design Non-blinded randomised control trial (RCT) with patient preference arm.

Setting Two multicentre teaching hospitals in London.

Participants Women less than 20 weeks’ pregnant with severe NVP and associated ketonuria (>1+).

Methods Women who agreed to the RCT were randomised via web-based application to either ambulatory or IP treatment. Women who declined randomisation underwent the treatment of their choice in the patient preference trial (PPT) arm. Treatment protocols, data collection and follow-up were the same for all participants.

Main outcome measures Primary outcome was reduction in Pregnancy Unique Quantification of Emesis (PUQE) score 48 hours after starting treatment. Secondary outcome measures were duration of treatment, improvement in symptom scores and ketonuria at 48 hours, reattendances within 7 days of discharge and comparison of symptoms at 7 days postdischarge.

Results 152/174 eligible women agreed to participate with 77/152 (51%) recruited to the RCT and 75/152 (49%) to the PPT.

Patients were initially compared in four groups (randomised IP, randomised OP, non-randomised IP and non-randomised OP). Comprehensive cohort analysis of participants in the randomised group (RCT) and non-randomised group (PPT) did not demonstrate any differences in patient demographics or baseline clinical characteristics. Pooled analysis of IP versus OP groups showed no difference in reduction in PUQE score at 48 hours (p=0.86). There was no difference in change in eating score (p=0.69), drinking score (p=0.77), well-being rating (p=0.64) or reduction in ketonuria (p=0.47) at 48 hours, with no difference in duration of index treatment episode (p=0.83) or reattendances within 7 days (p=0.52).

Conclusions Ambulatory management is an effective direct alternative to IP management of severe NVP. The trial also demonstrated that many women requiring treatment for severe NVP have strong preferences regarding treatment setting, which may need to be considered by care providers, especially given the psychological impact of severe NVP.

Trial registration number http://www.isrctn.com/ISRCTN24659467 (March 2014).

  • pregnancy
  • nausea
  • vomiting
  • treatment efficacy
  • ambulatory

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017566

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    Footnotes

    • Contributors The study idea was conceived by CB. CB and NM-J designed the study protocol and obtained ethical approval. JAF set up the trial at the secondary unit (St Mary’s Hospital, London, UK). NM-J, JAF and CB recruited patients and collected all data. AT performed statistical analysis. The draft article was written by NM-J. All other authors (CB, TB, JAF and AT) reviewed and revised the final article.

    • Funding Part-funded by the National Institute for Health Research (NIHR) under the Collaborations for Leadership in Applied Health Research and Care (CLAHRC) programme for North West London. TB is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London. The views expressed are those of the authors and not necessarily those of the NHS, NIHR or Department of Health.

    • Competing interests None declared.

    • Ethics approval NRES Committee Yorkshire & The Humber-Humber Bridge (REC reference 13/YH/0424).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Extra data can be accessed via the Dryad data repository at http://datadryad.org/ with the doi:10.5061/dryad.c3g48.