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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
© Broekhuijsen et al.; licensee BioMed Central Ltd. 2013
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 .
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).
- 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
- Bewley S, Shennan A: Hypitat and the fallacy of pregnancy interruption. Lancet. 2010, 375 (9709): 119-View ArticlePubMedGoogle Scholar
- 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
- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2393/13/232/prepub
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