Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial)

Chappell, LC; Green, M; Marlow, N; Sandall, J; Hunter, R; Robson, S; Bowler, U; Chiocchia, V; Hardy, P; Juszczak, E; Linsell, L; Placzek, A; Brocklehurst, P; Shennan, A

Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial)

Chappell, LC Green, M Marlow, N Sandall, J

Hunter, R Robson, S Bowler, U Chiocchia, V Hardy, P Juszczak, E Linsell, L Placzek, A Brocklehurst, P Shennan, A

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Publication Type:: Journal Article
Citation:: Trials, 2019, 20 (1)
Issue Date:: 2019-01-01

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Field	Value	Language
dc.contributor.author	Chappell, LC	en_US
dc.contributor.author	Green, M	en_US
dc.contributor.author	Marlow, N	en_US
dc.contributor.author	Sandall, J https://orcid.org/0000-0003-2000-743X	en_US
dc.contributor.author	Hunter, R	en_US
dc.contributor.author	Robson, S	en_US
dc.contributor.author	Bowler, U	en_US
dc.contributor.author	Chiocchia, V	en_US
dc.contributor.author	Hardy, P	en_US
dc.contributor.author	Juszczak, E	en_US
dc.contributor.author	Linsell, L	en_US
dc.contributor.author	Placzek, A	en_US
dc.contributor.author	Brocklehurst, P	en_US
dc.contributor.author	Shennan, A	en_US
dc.date.available	2018-12-18	en_US
dc.date.issued	2019-01-01	en_US
dc.identifier.citation	Trials, 2019, 20 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/135654
dc.description.abstract	© 2019 The Author(s). Background: Pre-eclampsia is a pregnancy disorder, characterised by hypertension and multisystem complications in the mother. The adverse outcomes of pre-eclampsia include severe hypertension, stroke, renal and hepatic injury, haemorrhage, fetal growth restriction and even death. The optimal time to instigate delivery to prevent morbidity when pre-eclampsia occurs between 34 and 37 weeks' gestation, without increasing problems related to infant immaturity or complications, remains unclear. Methods/design: The PHOENIX trial is a non-masked, randomised controlled trial, comparing planned early delivery (with initiation of delivery within 48 h of randomisation) with usual care (expectant management) in women with pre-eclampsia between 34 + 0 and 36 + 6 weeks' gestation. The primary objectives of the trial are to determine if planned delivery reduces adverse maternal outcomes, without increasing the short-term harm to infants (composite of perinatal deaths or neonatal unit admissions up to infant hospital discharge) or impacting long-term infant neurodevelopmental status at 2 years corrected age (Parent Report of Cognitive Abilities-Revised). Discussion: Current practice in the UK at the time of trial commencement for management of pre-eclampsia varies by gestation. Previous trials have shown that in women with pre-eclampsia after 37 weeks of gestion, delivery is initiated, as maternal complications are reduced without increasing fetal risks. Prior to 34 weeks of gestation, usual management aims to prolong pregnancy for fetal benefit, unless severe complications occur, necessitating preterm delivery. This trial aims to address the uncertainty for women where the balance of benefits and risks of delivery compared to expectant management are uncertain. Previous trials in this area have been undertaken, but have not provided a definitive answer, and the research question remains active. The results of this trial are expected to influence clinical practice internationally, through direct adoption and by incorporation into guidelines in countries with similar settings. Trial registration: ISRCTN01879376. Registered on 25 November 2013.	en_US
dc.relation.ispartof	Trials	en_US
dc.relation.isbasedon	10.1186/s13063-018-3150-1	en_US
dc.rights	info:eu-repo/semantics/openAccess
dc.subject.classification	Cardiovascular System & Hematology	en_US
dc.subject.classification	General & Internal Medicine	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Pre-Eclampsia	en_US
dc.subject.mesh	Premature Birth	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Delivery, Obstetric	en_US
dc.subject.mesh	Child Development	en_US
dc.subject.mesh	Age Factors	en_US
dc.subject.mesh	Gestational Age	en_US
dc.subject.mesh	Pregnancy	en_US
dc.subject.mesh	Time Factors	en_US
dc.subject.mesh	Child, Preschool	en_US
dc.subject.mesh	Infant, Newborn	en_US
dc.subject.mesh	England	en_US
dc.subject.mesh	Wales	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Multicenter Studies as Topic	en_US
dc.subject.mesh	Pragmatic Clinical Trials as Topic	en_US
dc.subject.mesh	Perinatal Death	en_US
dc.title	Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial)	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	20	en_US
utslib.for	1102 Cardiorespiratory Medicine and Haematology	en_US
utslib.for	1103 Clinical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Midwifery
utslib.copyright.status	open_access	*
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	20	en_US

Abstract:

© 2019 The Author(s). Background: Pre-eclampsia is a pregnancy disorder, characterised by hypertension and multisystem complications in the mother. The adverse outcomes of pre-eclampsia include severe hypertension, stroke, renal and hepatic injury, haemorrhage, fetal growth restriction and even death. The optimal time to instigate delivery to prevent morbidity when pre-eclampsia occurs between 34 and 37 weeks' gestation, without increasing problems related to infant immaturity or complications, remains unclear. Methods/design: The PHOENIX trial is a non-masked, randomised controlled trial, comparing planned early delivery (with initiation of delivery within 48 h of randomisation) with usual care (expectant management) in women with pre-eclampsia between 34 + 0 and 36 + 6 weeks' gestation. The primary objectives of the trial are to determine if planned delivery reduces adverse maternal outcomes, without increasing the short-term harm to infants (composite of perinatal deaths or neonatal unit admissions up to infant hospital discharge) or impacting long-term infant neurodevelopmental status at 2 years corrected age (Parent Report of Cognitive Abilities-Revised). Discussion: Current practice in the UK at the time of trial commencement for management of pre-eclampsia varies by gestation. Previous trials have shown that in women with pre-eclampsia after 37 weeks of gestion, delivery is initiated, as maternal complications are reduced without increasing fetal risks. Prior to 34 weeks of gestation, usual management aims to prolong pregnancy for fetal benefit, unless severe complications occur, necessitating preterm delivery. This trial aims to address the uncertainty for women where the balance of benefits and risks of delivery compared to expectant management are uncertain. Previous trials in this area have been undertaken, but have not provided a definitive answer, and the research question remains active. The results of this trial are expected to influence clinical practice internationally, through direct adoption and by incorporation into guidelines in countries with similar settings. Trial registration: ISRCTN01879376. Registered on 25 November 2013.

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http://hdl.handle.net/10453/135654