Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial).
Global health
Hypertension
Low- and middle-income countries
Perinatal
Pre-eclampsia
Pregnancy
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
23 Nov 2020
23 Nov 2020
Historique:
received:
29
07
2020
accepted:
11
11
2020
entrez:
24
11
2020
pubmed:
25
11
2020
medline:
22
6
2021
Statut:
epublish
Résumé
Pre-eclampsia is a pregnancy complication characterised by high blood pressure and multi-organ dysfunction in the mother. It is a leading contributor to maternal and perinatal mortality, with 99% of these deaths occurring in low- and middle-income countries (LMIC). Whilst clear guidelines exist for management of early-onset (< 34 weeks) and term (≥ 37 weeks) disease, the optimal timing of delivery in pre-eclampsia between 34 The CRADLE-4 Trial is a non-masked, randomised controlled trial comparing planned early delivery (initiation of delivery within 48 h of randomisation) with routine care (expectant management) in women with pre-eclampsia between 34 The World Health Organization recommends delivery for all women with pre-eclampsia from 37 weeks onwards, based on evidence showing clear maternal benefit without increased neonatal risk. Before 34 weeks, watchful waiting is preferred, with delivery recommended only when there is severe maternal or fetal compromise, due to the neonatal risks associated with early preterm delivery. Currently, there is a lack of guidance for clinicians managing women with pre-eclampsia between 34 ISRCTN 10672137 . Registered on 28 November 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Pre-eclampsia is a pregnancy complication characterised by high blood pressure and multi-organ dysfunction in the mother. It is a leading contributor to maternal and perinatal mortality, with 99% of these deaths occurring in low- and middle-income countries (LMIC). Whilst clear guidelines exist for management of early-onset (< 34 weeks) and term (≥ 37 weeks) disease, the optimal timing of delivery in pre-eclampsia between 34
METHODS
METHODS
The CRADLE-4 Trial is a non-masked, randomised controlled trial comparing planned early delivery (initiation of delivery within 48 h of randomisation) with routine care (expectant management) in women with pre-eclampsia between 34
DISCUSSION
CONCLUSIONS
The World Health Organization recommends delivery for all women with pre-eclampsia from 37 weeks onwards, based on evidence showing clear maternal benefit without increased neonatal risk. Before 34 weeks, watchful waiting is preferred, with delivery recommended only when there is severe maternal or fetal compromise, due to the neonatal risks associated with early preterm delivery. Currently, there is a lack of guidance for clinicians managing women with pre-eclampsia between 34
TRIAL REGISTRATION
BACKGROUND
ISRCTN 10672137 . Registered on 28 November 2019.
Identifiants
pubmed: 33228794
doi: 10.1186/s13063-020-04888-w
pii: 10.1186/s13063-020-04888-w
pmc: PMC7684962
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
960Subventions
Organisme : Medical Research Council
ID : MR/N006240/1
Pays : United Kingdom
Organisme : Department of Health
ID : RP-2014-05-019
Pays : United Kingdom
Organisme : Medical Research Council (UK)
ID : MR/R021376/1
Références
Lancet. 2019 Sep 28;394(10204):1181-1190
pubmed: 31472930
Ultrasound Obstet Gynecol. 2019 Apr;53(4):443-453
pubmed: 30697855
Lancet. 2005 Feb 19-25;365(9460):711-22
pubmed: 15721478
Lancet. 1974 Jul 13;2(7872):81-4
pubmed: 4136544
Afr Health. 1996 Sep;18(6):20-1
pubmed: 12291734
Lancet Glob Health. 2018 Nov;6(11):e1186-e1195
pubmed: 30322649
BMJ. 2001 Nov 10;323(7321):1123-4
pubmed: 11701584
Semin Perinatol. 2009 Jun;33(3):130-7
pubmed: 19464502
Lancet. 2015 Jun 20;385(9986):2492-501
pubmed: 25817374
BMJ Glob Health. 2017 Aug 30;2(3):e000398
pubmed: 29082019
BMJ. 2012 Sep 14;345:e5840
pubmed: 22983531
Lancet. 2010 Aug 21;376(9741):631-44
pubmed: 20598363
Hypertens Pregnancy. 2010;29(3):262-70
pubmed: 20670151
Lancet. 2015 Feb 14;385(9968):629-639
pubmed: 25458726
Int J Gynaecol Obstet. 2019 May;145 Suppl 1:1-33
pubmed: 31111484
Hypertension. 2018 Jul;72(1):24-43
pubmed: 29899139
PLoS Med. 2014 Jan;11(1):e1001589
pubmed: 24465185