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
Koopmans CM, Bijlenga D, Groen H, Vijgen SM, Aarnoudse JG, Bekedam DJ, van den Berg PP, de Boer K, Burggraaff JM, Bloemenkamp KW, Drogtrop AP, Franx A, de Groot CJ, Huisjes AJ, Kwee A, van Loon AJ, Lub A, Papatsonis DN, van der Post JA, Roumen FJ, Scheepers HC, Willekes C, Mol BW, van Pampus MG, HYPITAT study group. Lancet. 2009 Sep 19;374(9694):979-88
This multicentre, open-label RCT examined whether induction of labor was superior to expectant management in pregnancies complicated by gestational hypertension or mild pre-eclampsia.
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Abstract:
BACKGROUND: Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. METHODS: We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. FINDINGS: 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p<0.0001). No cases of maternal or neonatal death or eclampsia were recorded. INTERPRETATION: Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. FUNDING: ZonMw.
October 24th, 2009 at 7:14 pm
An interesting paper. As a Nephrologist, I occasionally am asked to see pregnant women with hypertension and proteinuria. I’d be very interested to see what our colleagues in Obstetrics think about this article. I am concerned that this article will increase obstetrical interventions based on an article that looked at a composite endpoint that included proteinuria and worsening hypertension. It seems that hard clinical endpoints (like infant/maternal outcomes) did not drive the statistically significant difference. So, we’d essentially be recommending early intervention to prevent outcomes such as progressive proteinuria/hypertension, which may have warranted intervention on their own.
Reminds me a bit of the article
Heparin plus Alteplase Compared with Heparin Alone in Patients with Submassive Pulmonary Embolism
http://content.nejm.org/cgi/content/abstract/347/15/1143
whereby thrombolyis in submassive PE seemed to reduce the combined endpoint which essentially was driven by the need for rescue thrombolysis.
What do others think?