Correction: 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
نویسندگان
چکیده
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).
منابع مشابه
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
BACKGROUND Gestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as t...
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