Immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy between 34 and 37 weeks of gestation (HYPITAT-II): an open-label, randomised controlled trial

Volume 385, Issue 9986, 20–26 June 2015, Pages 2492–2501

Articles

• Kim Broekhuijsen, MD^{t, ,} ,
• Gert-Jan van Baaren, MD^a,
• Maria G van Pampus, MD^c,
• Wessel Ganzevoort, MD^a,
• J Marko Sikkema, MD^d,
• Mallory D Woiski, MD^e,
• Martijn A Oudijk, MD^f,
• Kitty W M Bloemenkamp, MD^g,
• Hubertina C J Scheepers, MD^h,
• Henk A Bremer, MDⁱ,
• Robbert J P Rijnders, MD^j,
• Aren J van Loon, MD^k,
• Denise A M Perquin, MD^l,
• Jan M J Sporken, MD^m,
• Dimitri N M Papatsonis, MDⁿ,
• Marloes E van Huizen, MD^o,
• Corla B Vredevoogd, MD^p,
• Jozien T J Brons, MD^q,
• Mesrure Kaplan, MD^r,

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doi:10.1016/S0140-6736(14)61998-X

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Refers To

• Jim Thornton, Lelia Duley

• Gestational hypertension before term: observe or deliver?

• The Lancet, Volume 385, Issue 9986, 20–26 June 2015, Pages 2441-2443
• •  Purchase PDF - $35.95

Referred to by

• Department of Error

• The Lancet, Volume 387, Issue 10021, 27 February–4 March 2016, Page 848
• •  PDF (43 K)

• Anna Dietl, Juliane Farthmann

• Gestational hypertension and advanced maternal age

• The Lancet, Volume 386, Issue 10004, 24–30 October 2015, Pages 1627-1628
• •  Purchase PDF - $35.95

• Kim Broekhuijsen, Henk Groen, Paul P van den Berg, Ben W J Mol, Maureen T M Franssen, Josje Langenveld, HYPITAT-II study group

• Gestational hypertension and advanced maternal age – Authors' reply

• The Lancet, Volume 386, Issue 10004, 24–30 October 2015, Page 1628
• •  Purchase PDF - $35.95

• Jim Thornton, Lelia Duley

• Gestational hypertension before term: observe or deliver?

• The Lancet, Volume 385, Issue 9986, 20–26 June 2015, Pages 2441-2443
• •  Purchase PDF - $35.95

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Summary

Background

There is little evidence to guide the management of women with hypertensive disorders in late preterm pregnancy. We investigated the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes in such women.

Methods

We did an open-label, randomised controlled trial, in seven academic hospitals and 44 non-academic hospitals in the Netherlands. Women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation were randomly allocated to either induction of labour or caesarean section within 24 h (immediate delivery) or a strategy aimed at prolonging pregnancy until 37 weeks of gestation (expectant monitoring). The primary outcomes were a composite of adverse maternal outcomes (thromboembolic disease, pulmonary oedema, eclampsia, HELLP syndrome, placental abruption, or maternal death), and neonatal respiratory distress syndrome, both analysed by intention-to-treat. This study is registered with the Netherlands Trial Register (NTR1792).

Findings

Between March 1, 2009, and Feb 21, 2013, 897 women were invited to participate, of whom 703 were enrolled and randomly assigned to immediate delivery (n=352) or expectant monitoring (n=351). The composite adverse maternal outcome occurred in four (1·1%) of 352 women allocated to immediate delivery versus 11 (3·1%) of 351 women allocated to expectant monitoring (relative risk [RR] 0·36, 95% CI 0·12–1·11; p=0·069). Respiratory distress syndrome was diagnosed in 20 (5·7%) of 352 neonates in the immediate delivery group versus six (1·7%) of 351 neonates in the expectant monitoring group (RR 3·3, 95% CI 1·4–8·2; p=0·005). No maternal or perinatal deaths occurred.

Interpretation

For women with non-severe hypertensive disorders at 34–37 weeks of gestation, immediate delivery might reduce the already small risk of adverse maternal outcomes. However, it significantly increases the risk of neonatal respiratory distress syndrome, therefore, routine immediate delivery does not seem justified and a strategy of expectant monitoring until the clinical situation deteriorates can be considered.

Funding

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Correspondence to: Kim Broekhuijsen, University of Groningen, University Medical Center Groningen, Department of Obstetrics and Gynecology, CB21, PO Box 30 001, 9700 RB Groningen, Netherlands

Copyright © 2015 Elsevier Ltd. All rights reserved.