A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA).
Antihypertensives
Blood pressure
Hypertension
Pregnancy
Randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
12 Sep 2023
12 Sep 2023
Historique:
received:
26
06
2023
accepted:
11
08
2023
medline:
14
9
2023
pubmed:
13
9
2023
entrez:
12
9
2023
Statut:
epublish
Résumé
Approximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and perinatal outcomes, and as treatment improves maternal outcomes, antihypertensive treatment is recommended. Previous trials have been unable to provide a definitive answer on which antihypertensive treatment is associated with optimal maternal and neonatal outcomes and the need for robust evidence evaluating maternal and infant benefits and risks remains an important, unanswered question for research and clinical communities. The Giant PANDA study is a pragmatic, open-label, multicentre, randomised controlled trial of a treatment initiation strategy with nifedipine (calcium channel blocker), versus labetalol (mixed alpha/beta blocker) in 2300 women with pregnancy hypertension. The primary objective is to evaluate if treatment with nifedipine compared to labetalol in women with pregnancy hypertension reduces severe maternal hypertension without increasing fetal or neonatal death or neonatal unit admission. Subgroup analyses will be undertaken by hypertension type (chronic, gestational, pre-eclampsia), diabetes (yes, no), singleton (yes, no), self-reported ethnicity (Black, all other), and gestational age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis. This trial aims to address the uncertainty of which antihypertensive treatment is associated with optimal maternal and neonatal outcomes. The trial results are intended to provide definitive evidence to inform guidelines and linked, shared decision-making tools, thus influencing clinical practice. EudraCT number: 2020-003410-12, ISRCTN: 12,792,616 registered on 18 November 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Approximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and perinatal outcomes, and as treatment improves maternal outcomes, antihypertensive treatment is recommended. Previous trials have been unable to provide a definitive answer on which antihypertensive treatment is associated with optimal maternal and neonatal outcomes and the need for robust evidence evaluating maternal and infant benefits and risks remains an important, unanswered question for research and clinical communities.
METHODS
METHODS
The Giant PANDA study is a pragmatic, open-label, multicentre, randomised controlled trial of a treatment initiation strategy with nifedipine (calcium channel blocker), versus labetalol (mixed alpha/beta blocker) in 2300 women with pregnancy hypertension. The primary objective is to evaluate if treatment with nifedipine compared to labetalol in women with pregnancy hypertension reduces severe maternal hypertension without increasing fetal or neonatal death or neonatal unit admission. Subgroup analyses will be undertaken by hypertension type (chronic, gestational, pre-eclampsia), diabetes (yes, no), singleton (yes, no), self-reported ethnicity (Black, all other), and gestational age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis.
DISCUSSION
CONCLUSIONS
This trial aims to address the uncertainty of which antihypertensive treatment is associated with optimal maternal and neonatal outcomes. The trial results are intended to provide definitive evidence to inform guidelines and linked, shared decision-making tools, thus influencing clinical practice.
TRIAL REGISTRATION
BACKGROUND
EudraCT number: 2020-003410-12, ISRCTN: 12,792,616 registered on 18 November 2020.
Identifiants
pubmed: 37700365
doi: 10.1186/s13063-023-07582-9
pii: 10.1186/s13063-023-07582-9
pmc: PMC10496358
doi:
Substances chimiques
Labetalol
R5H8897N95
Nifedipine
I9ZF7L6G2L
Antihypertensive Agents
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
584Subventions
Organisme : Health Technology Assessment Programme
ID : NIHR128721
Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
N Engl J Med. 2022 May 12;386(19):1781-1792
pubmed: 35363951
Health Qual Life Outcomes. 2004 Feb 26;2:12
pubmed: 14987333
BMJ. 2014 Apr 15;348:g2301
pubmed: 24735917
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
Hypertension. 2022 Mar;79(3):614-628
pubmed: 35138877
Cochrane Database Syst Rev. 2018 Oct 01;10:CD002252
pubmed: 30277556
Pregnancy Hypertens. 2012 Jan;2(1):1-7
pubmed: 26104983
Med Decis Making. 2012 Sep-Oct;32(5):722-32
pubmed: 22990087
Hypertension. 2017 Nov;70(5):915-922
pubmed: 28893900
JAMA. 2022 May 3;327(17):1666-1678
pubmed: 35503345
Lancet. 2010 Aug 21;376(9741):631-44
pubmed: 20598363
JAMA. 2022 May 3;327(17):1656-1665
pubmed: 35503346
Am J Obstet Gynecol. 2022 Feb;226(2S):S1222-S1236
pubmed: 32828743
Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288
pubmed: 31823381
Arch Dis Child Educ Pract Ed. 2019 Feb;104(1):29-32
pubmed: 29903743
Lancet. 2011 Jan 15;377(9761):219-27
pubmed: 21185591
Paediatr Perinat Epidemiol. 2018 Jul;32(4):380-387
pubmed: 29727020
N Engl J Med. 2015 Jan 29;372(5):407-17
pubmed: 25629739
Value Health. 2022 Jan;25(1):3-9
pubmed: 35031096