Randomized Controlled Trial

.2015 Jun 20;385(9986):2492-501.

doi: 10.1016/S0140-6736(14)61998-X. Epub 2015 Mar 25.

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

Kim Broekhuijsen¹, Gert-Jan van Baaren², Maria G van Pampus³, Wessel Ganzevoort², J Marko Sikkema⁴, Mallory D Woiski⁵, Martijn A Oudijk⁶, Kitty W M Bloemenkamp⁷, Hubertina C J Scheepers⁸, Henk A Bremer⁹, Robbert J P Rijnders¹⁰, Aren J van Loon¹¹, Denise A M Perquin¹², Jan M J Sporken¹³, Dimitri N M Papatsonis¹⁴, Marloes E van Huizen¹⁵, Corla B Vredevoogd¹⁶, Jozien T J Brons¹⁷, Mesrure Kaplan¹⁸, Anton H van Kaam¹⁹, Henk Groen²⁰, Martina M Porath²¹, Paul P van den Berg²², Ben W J Mol²³, Maureen T M Franssen²², Josje Langenveld²⁴; HYPITAT-II study group

Collaborators, Affiliations

Collaborators

HYPITAT-II study group:
W Ganzevoort, E S A van der Akker, C B Fong, P Hummel, M A Muller, C Bax, B B J Hermsen, M Hemelaar, G Kleiverda, B Doekhie, H Visser, P J M Pernet, A Mozes, H van Zandvoort, E van Beek, A Kwee, M A Oudijk, A J M Huisjes, E H J Zanders, N W E Schuitemaker, K Deurlo, I Evers, K W M Bloemenkamp, C A van Meir, C B Vredevoogd, M E van Huizen, G A van Unnik, M M Porath, C M van Oirschot, R J P Rijnders, L C J Scheepers, J Langenveld, J Langenveld, F Roumen, J Langenveld, E J Wijnen, R Aardenburg, M T M Franssen, A J van Loon, D Perquin, A Koops, H A Bremer, D N M Papatsonis, N van Gemund, B M C Akerboom, E Smid-Koopman, K de Boer, M D Woiski, J M J Sporken, A C de Wit, A A van Ginkel, T E M Verhagen, R H Stigter, J T J Brons, J M Sikkema, M Kaplan

Affiliations

¹ Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. Electronic address: k.broekhuijsen@gmail.com.
² Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
³ Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.
⁴ Department of Obstetrics and Gynaecology, ZGT Almelo, Almelo, Netherlands.
⁵ Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, Netherlands.
⁶ Department of Obstetrics, University Medical Center Utrecht, Utrecht, Netherlands.
⁷ Department of Obstetrics, Leiden University Medical Center, Leiden, Netherlands.
⁸ Department of Obstetrics and Gynaecology, Grow, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, Netherlands.
⁹ Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, Netherlands.
¹⁰ Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.
¹¹ Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, Netherlands.
¹² Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, Netherlands.
¹³ Department of Obstetrics and Gynaecology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.
¹⁴ Department of Obstetrics and Gynaecology, Amphia Hospital Breda, Breda, Netherlands.
¹⁵ Department of Obstetrics and Gynaecology, HagaZiekenhuis, The Hague, Netherlands.
¹⁶ Department of Obstetrics and Gynaecology, Medical Center Haaglanden, The Hague, Netherlands.
¹⁷ Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, Netherlands.
¹⁸ Department of Obstetrics and Gynaecology, Röpcke-Zweers Hospital, Hardenberg, Netherlands.
¹⁹ Department of Neonatology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, Netherlands.
²⁰ Department of Epidemiology-HPC FA40, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
²¹ Department of Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, Netherlands.
²² Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
²³ The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
²⁴ Department of Obstetrics and Gynaecology, Atrium Medical Centre Parkstad, Heerlen, Netherlands.

PMID:25817374
DOI: 10.1016/S0140-6736(14)61998-X

Randomized Controlled Trial

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

Kim Broekhuijsen et al. Lancet.2015.

.2015 Jun 20;385(9986):2492-501.

doi: 10.1016/S0140-6736(14)61998-X. Epub 2015 Mar 25.

Authors

Collaborators

HYPITAT-II study group:
W Ganzevoort, E S A van der Akker, C B Fong, P Hummel, M A Muller, C Bax, B B J Hermsen, M Hemelaar, G Kleiverda, B Doekhie, H Visser, P J M Pernet, A Mozes, H van Zandvoort, E van Beek, A Kwee, M A Oudijk, A J M Huisjes, E H J Zanders, N W E Schuitemaker, K Deurlo, I Evers, K W M Bloemenkamp, C A van Meir, C B Vredevoogd, M E van Huizen, G A van Unnik, M M Porath, C M van Oirschot, R J P Rijnders, L C J Scheepers, J Langenveld, J Langenveld, F Roumen, J Langenveld, E J Wijnen, R Aardenburg, M T M Franssen, A J van Loon, D Perquin, A Koops, H A Bremer, D N M Papatsonis, N van Gemund, B M C Akerboom, E Smid-Koopman, K de Boer, M D Woiski, J M J Sporken, A C de Wit, A A van Ginkel, T E M Verhagen, R H Stigter, J T J Brons, J M Sikkema, M Kaplan

Affiliations

¹ Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. Electronic address: k.broekhuijsen@gmail.com.
² Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
³ Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.
⁴ Department of Obstetrics and Gynaecology, ZGT Almelo, Almelo, Netherlands.
⁵ Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, Netherlands.
⁶ Department of Obstetrics, University Medical Center Utrecht, Utrecht, Netherlands.
⁷ Department of Obstetrics, Leiden University Medical Center, Leiden, Netherlands.
⁸ Department of Obstetrics and Gynaecology, Grow, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, Netherlands.
⁹ Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, Netherlands.
¹⁰ Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.
¹¹ Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, Netherlands.
¹² Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, Netherlands.
¹³ Department of Obstetrics and Gynaecology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.
¹⁴ Department of Obstetrics and Gynaecology, Amphia Hospital Breda, Breda, Netherlands.
¹⁵ Department of Obstetrics and Gynaecology, HagaZiekenhuis, The Hague, Netherlands.
¹⁶ Department of Obstetrics and Gynaecology, Medical Center Haaglanden, The Hague, Netherlands.
¹⁷ Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, Netherlands.
¹⁸ Department of Obstetrics and Gynaecology, Röpcke-Zweers Hospital, Hardenberg, Netherlands.
¹⁹ Department of Neonatology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, Netherlands.
²⁰ Department of Epidemiology-HPC FA40, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
²¹ Department of Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, Netherlands.
²² Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
²³ The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
²⁴ Department of Obstetrics and Gynaecology, Atrium Medical Centre Parkstad, Heerlen, Netherlands.

PMID:25817374
DOI: 10.1016/S0140-6736(14)61998-X

Erratum in

Lancet. 2016 Feb 27;387(10021):848

Abstract

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: ZonMw.

PubMed Disclaimer

Comment in

Gestational hypertension before term: observe or deliver?
Thornton J, Duley L.Thornton J, et al.Lancet. 2015 Jun 20;385(9986):2441-3. doi: 10.1016/S0140-6736(14)62454-5. Epub 2015 Mar 25.Lancet. 2015.PMID:25817376No abstract available.
Immediate delivery in women with non-severe hypertensive disorders at 34-37 weeks' gestation does not reduce maternal complications, and increases neonatal risks more than under expectant management.
Thangaratinam S.Thangaratinam S.Evid Based Med. 2015 Oct;20(5):184-5. doi: 10.1136/ebmed-2015-110219. Epub 2015 Aug 11.Evid Based Med. 2015.PMID:26265745No abstract available.
Immediate preterm delivery for pregnancy hypertension increases risk of neonatal respiratory distress.
Nutt RJ.Nutt RJ.Evid Based Nurs. 2016 Jan;19(1):8. doi: 10.1136/eb-2015-102155. Epub 2015 Oct 5.Evid Based Nurs. 2016.PMID:26438698No abstract available.
Gestational hypertension and advanced maternal age.
Dietl A, Farthmann J.Dietl A, et al.Lancet. 2015 Oct 24;386(10004):1627-8. doi: 10.1016/S0140-6736(15)00532-2.Lancet. 2015.PMID:26595630No abstract available.
Gestational hypertension and advanced maternal age - Authors' reply.
Broekhuijsen K, Groen H, van den Berg PP, Mol BW, Franssen MT, Langenveld J; HYPITAT-II study group.Broekhuijsen K, et al.Lancet. 2015 Oct 24;386(10004):1628. doi: 10.1016/S0140-6736(15)00533-4.Lancet. 2015.PMID:26595632No abstract available.
Hypertension at late preterm gestation: deliver immediately or watch and wait?
Boyle EM.Boyle EM.Acta Paediatr. 2017 Aug;106(8):1367-1368. doi: 10.1111/apa.13802. Epub 2017 Apr 2.Acta Paediatr. 2017.PMID:28370440No abstract available.

Cited by

Evaluation of biomarkers for treatment selection using individual participant data from multiple clinical trials.
Kang C, Janes H, Tajik P, Groen H, Mol B, Koopmans C, Broekhuijsen K, Zwertbroek E, van Pampus M, Franssen M.Kang C, et al.Stat Med. 2018 Apr 30;37(9):1439-1453. doi: 10.1002/sim.7608. Epub 2018 Feb 14.Stat Med. 2018.PMID:29444553Free PMC article.
A literature review and best practice advice for second and third trimester risk stratification, monitoring, and management of pre-eclampsia: Compiled by the Pregnancy and Non-Communicable Diseases Committee of FIGO (the International Federation of Gynecology and Obstetrics).
Poon LC, Magee LA, Verlohren S, Shennan A, von Dadelszen P, Sheiner E, Hadar E, Visser G, Da Silva Costa F, Kapur A, McAuliffe F, Nazareth A, Tahlak M, Kihara AB, Divakar H, McIntyre HD, Berghella V, Yang H, Romero R, Nicolaides KH, Melamed N, Hod M.Poon LC, et al.Int J Gynaecol Obstet. 2021 Jul;154 Suppl 1(Suppl 1):3-31. doi: 10.1002/ijgo.13763.Int J Gynaecol Obstet. 2021.PMID:34327714Free PMC article.Review.No abstract available.
Managing pregnancy in chronic kidney disease: improving outcomes for mother and baby.
Fitzpatrick A, Mohammadi F, Jesudason S.Fitzpatrick A, et al.Int J Womens Health. 2016 Jul 14;8:273-85. doi: 10.2147/IJWH.S76819. eCollection 2016.Int J Womens Health. 2016.PMID:27471410Free PMC article.Review.
Expectant Management of Hypertensive Disorders of Pregnancy and Future Cardiovascular Morbidity.
Rosenbloom JI, Lewkowitz AK, Lindley KJ, Nelson DM, Macones GA, Cahill AG, Olsen MA, Stout MJ.Rosenbloom JI, et al.Obstet Gynecol. 2020 Jan;135(1):27-35. doi: 10.1097/AOG.0000000000003567.Obstet Gynecol. 2020.PMID:31809423Free PMC article.
Planned early delivery versus expectant management for hypertensive disorders from 34 weeks gestation to term.
Cluver C, Novikova N, Koopmans CM, West HM.Cluver C, et al.Cochrane Database Syst Rev. 2017 Jan 15;1(1):CD009273. doi: 10.1002/14651858.CD009273.pub2.Cochrane Database Syst Rev. 2017.PMID:28106904Free PMC article.Review.

See all "Cited by" articles

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

NTR/NTR1792

Related information

Cited in Books

LinkOut - more resources

Full Text Sources
- ClinicalKey
- Elsevier Science
Other Literature Sources
- H1 Connect - Access expert opinions and insights on biomedical research.
Medical
- MedlinePlus Health Information

Movatterモバイル変換

Account

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Full text links

Actions

Share

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Erratum in

Abstract

Comment in

Similar articles

Cited by

Publication types

MeSH terms

Associated data

Related information

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical