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Erratum to: Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia between 34 and 37 weeks’ gestation (HYPITAT-II): a multicentre, open-label randomised controlled trial

  • Kim Broekhuijsen1Email author,
  • Josje Langenveld2,
  • Gert-Jan van Baaren3,
  • Mariëlle G van Pampus4,
  • Anton H van Kaam3,
  • Henk Groen5,
  • Martina Porath6,
  • Maureen TM Franssen1,
  • Ben W Mol3 and
  • HYPITAT-II study group
BMC Pregnancy and Childbirth201313:232

https://doi.org/10.1186/1471-2393-13-232

Received: 24 January 2013

Accepted: 6 December 2013

Published: 23 December 2013

The original article was published in BMC Pregnancy and Childbirth 2011 11:50

The earliest draft versions of the protocol for our study described the composite adverse maternal outcome as one or more of progression to severe disease, pulmonary edema, thrombo-embolic disease, HELLP syndrome, eclampsia, placental abruption or maternal death. However, there is ongoing debate as to whether progression to severe disease should be considered an adverse maternal outcome [1, 2]. Therefore, after obtaining funding which enabled us to increase our sample size to the current sample size of 680, we decided to study a composite adverse maternal outcome excluding progression to severe disease. These changes were incorporated in the protocol as submitted to and approved by the instutional review board;* the current protocol is available from our website (http://www.studies-obsgyn.nl/hypitat2/page.asp?page_id=642). Unfortunately, the change to the maternal outcome definition was not incorporated into the published protocol, which incorrectly includes progression to severe disease in the composite adverse maternal outcome [3].

We also discovered minor differences between the published protocol and the IRB approved protocol. The definition for neonatal morbidity should have contained meconium aspiration syndrome, pneumothorax and/or pneumomediastinum, periventricular leucomalacia, convulsions and other neurological abnormalities. Finally, low 5-minute Apgar score should have been defined as below 7 (as opposed to below 3), and low umbilical artery pH as below 7.05 (as opposed to below 7.0).

These discrepancies were discovered and the correction submitted for publication during recruitment.

* Medical Ethics Committee, Academic Medical Centre, Amsterdam, the Netherlands (ref. 2008/244).

Notes

Authors’ Affiliations

(1)
Department of Obstetrics and Gynecology, University of Groningen, University Medical Center Groningen
(2)
Department of Obstetrics and Gynecology, Atrium Medical Center
(3)
Department of Obstetrics and Gynecology, Academic Medical Center
(4)
Department Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis
(5)
Department of Epidemiology, University of Groningen, University Medical Center Groningen
(6)
Department of Obstetrics and Gynecology, Maxima Medical Center

References

  1. Koopmans CM, Bijlenga D, Groen H, Vijgen SM, Aarnoudse JG, Bekedam DJ, HYPITAT study group, et al: Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks’ gestation (HYPITAT): a multicentre, open-label randomised controlled trial. Lancet. 2009, 374: 979-988. 10.1016/S0140-6736(09)60736-4.View ArticlePubMedGoogle Scholar
  2. Bewley S, Shennan A: Hypitat and the fallacy of pregnancy interruption. Lancet. 2010, 375 (9709): 119-View ArticlePubMedGoogle Scholar
  3. Langenveld J, Broekhuijsen K, van Baaren G, van Pampus MG, van Kaam AH, Groen H, Porath M, Mol BW, HYPITAT-II study group: Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia between 34 and 37 weeks’ gestation (HYPITAT-II): a multicentre, open-label randomised controlled trial. BMC Pregnancy Childbirth. 2011, 11: 50-10.1186/1471-2393-11-50.View ArticlePubMedPubMed CentralGoogle Scholar
  4. Pre-publication history

    1. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2393/13/232/prepub

Copyright

© Broekhuijsen et al.; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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