Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial).
Age Factors
Child Development
Child, Preschool
Delivery, Obstetric
/ adverse effects
England
Female
Gestational Age
Humans
Infant, Newborn
Multicenter Studies as Topic
Perinatal Death
/ prevention & control
Pragmatic Clinical Trials as Topic
Pre-Eclampsia
/ diagnosis
Pregnancy
Premature Birth
Time Factors
Treatment Outcome
Wales
Pre-eclampsia
hypertension
perinatal
pregnancy
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
28 Jan 2019
28 Jan 2019
Historique:
received:
24
09
2018
accepted:
18
12
2018
entrez:
30
1
2019
pubmed:
30
1
2019
medline:
29
5
2019
Statut:
epublish
Résumé
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. 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 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. ISRCTN01879376 . Registered on 25 November 2013.
Sections du résumé
BACKGROUND
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
METHODS
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
DISCUSSION
CONCLUSIONS
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
BACKGROUND
ISRCTN01879376 . Registered on 25 November 2013.
Identifiants
pubmed: 30691508
doi: 10.1186/s13063-018-3150-1
pii: 10.1186/s13063-018-3150-1
pmc: PMC6350286
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
85Subventions
Organisme : Department of Health
ID : 12/25/03
Pays : United Kingdom
Organisme : Department of Health
ID : HTA/15/59/06
Pays : United Kingdom
Organisme : Department of Health
ID : RP-2014-05-019
Pays : United Kingdom
Organisme : National Institute for Health Research
ID : 12/25/03
Commentaires et corrections
Type : CommentIn
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