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

Lucy C Chappell; Marcus Green; Neil Marlow; Jane Sandall; Rachael Hunter; Stephen Robson; Ursula Bowler; Virginia Chiocchia; Pollyanna Hardy; Edmund Juszczak; Louise Linsell; Anna Placzek; Peter Brocklehurst; Andrew Shennan

doi:10.1186/s13063-018-3150-1

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

Lucy C Chappell, Marcus Green, Neil Marlow, Jane Sandall, Rachael Hunter, Stephen Robson, Ursula Bowler, Virginia Chiocchia, Pollyanna Hardy, Edmund Juszczak, Louise Linsell, Anna Placzek, Peter Brocklehurst, Andrew Shennan

Birmingham Clinical Trials Unit

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

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Abstract

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.

Original language	English
Article number	85
Journal	Trials
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s13063-018-3150-1
Publication status	Published - 28 Jan 2019

Keywords

Pre-eclampsia
hypertension
pregnancy
perinatal

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Chappell_et_al_Planned_delivery_or_expectant_management_for_late_preterm_Trials_2019
Checked for eligibility 06/02/2019 Published in Trials https://doi.org/10.1186/s13063-018-3150-1
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Chappell, L. C., 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. (2019). Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial). Trials, 20(1), Article 85. https://doi.org/10.1186/s13063-018-3150-1

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abstract = "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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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 2019, 'Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial)', Trials, vol. 20, no. 1, 85. https://doi.org/10.1186/s13063-018-3150-1

TY - JOUR

T1 - Planned delivery or expectant management for late preterm pre-eclampsia

T2 - study protocol for a randomised controlled trial (PHOENIX trial)

AU - Chappell, Lucy C

AU - Green, Marcus

AU - Marlow, Neil

AU - Sandall, Jane

AU - Hunter, Rachael

AU - Robson, Stephen

AU - Bowler, Ursula

AU - Chiocchia, Virginia

AU - Hardy, Pollyanna

AU - Juszczak, Edmund

AU - Linsell, Louise

AU - Placzek, Anna

AU - Brocklehurst, Peter

AU - Shennan, Andrew

PY - 2019/1/28

Y1 - 2019/1/28

N2 - 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.

AB - 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.

KW - Pre-eclampsia

KW - hypertension

KW - pregnancy

KW - perinatal

U2 - 10.1186/s13063-018-3150-1

DO - 10.1186/s13063-018-3150-1

M3 - Article

C2 - 30691508

SN - 1745-6215

VL - 20

JO - Trials

JF - Trials

IS - 1

M1 - 85

ER -

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

Abstract

Keywords

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