Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis

Abstract Background Early onset fetal growth restriction secondary to placental insufficiency can lead to severe maternal and neonatal morbidity and mortality. Pre-clinical studies and a few small randomised clinical trials have suggested that phosphodiesterase type 5 (PDE-5) inhibitors may have pro...

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Autores principales:	Jessica Liauw, Katie Groom, Wessel Ganzevoort, Christian Gluud, Christopher J. D. McKinlay, Andrew Sharp, Laura Mackay, Chirag Kariya, Ken Lim, Peter von Dadelszen, Jacqueline Limpens, Janus C. Jakobsen, the STRIDER Consortium
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Fetal growth restriction Phosphodiesterase type 5 inhibitor Randomised clinical trial Trial sequential analysis Aggregate meta-analysis Individual patient data meta-analysis Medicine R
Acceso en línea:	https://doaj.org/article/79c934a25fd948e0a218890e5020aafc
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spelling	oai:doaj.org-article:79c934a25fd948e0a218890e5020aafc2021-12-05T12:05:49ZShort-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis10.1186/s13643-021-01849-52046-4053https://doaj.org/article/79c934a25fd948e0a218890e5020aafc2021-12-01T00:00:00Zhttps://doi.org/10.1186/s13643-021-01849-5https://doaj.org/toc/2046-4053Abstract Background Early onset fetal growth restriction secondary to placental insufficiency can lead to severe maternal and neonatal morbidity and mortality. Pre-clinical studies and a few small randomised clinical trials have suggested that phosphodiesterase type 5 (PDE-5) inhibitors may have protective effects against placental insufficiency in this context; however, robust evidence is lacking. The STRIDER Consortium conducted four randomised trials to investigate the use of a PDE-5 inhibitor, sildenafil, for the treatment of early onset fetal growth restriction. We present a protocol for the pre-planned systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis of these and other eligible trials. The main objective of this study will be to evaluate the effects of PDE-5 inhibitors on neonatal morbidity compared with placebo or no intervention among pregnancies with fetal growth restriction. Methods We will search the following electronic databases with no language or date restrictions: OVID MEDLINE, OVID EMBASE, the Cochrane Controlled Register of Trials (CENTRAL), and the clinical trial registers Clinicaltrials.gov and World Health Organisation International Clinical Trials Registry Platform (ICTRP). We will identify randomised trials of PDE-5 inhibitors in singleton pregnancies with growth restriction. Two reviewers will independently screen all citations, full-text articles, and abstract data. Our primary outcome will be infant survival without evidence of serious adverse neonatal outcome. Secondary outcomes will include gestational age at birth and birth weight z-scores. We will assess bias using the Cochrane Risk of Bias 2 tool. We will conduct aggregate meta-analysis using fixed and random effects models, Trial Sequential Analysis, and individual participant data meta-analysis using one- and two-stage approaches. The certainty of evidence will be assessed with GRADE. Discussion This pre-defined protocol will minimise bias during analysis and interpretation of results, toward the goal of providing robust evidence regarding the use of PDE-5 inhibitors for the treatment of early onset fetal growth restriction. Systematic review registration PROSPERO (CRD42017069688).Jessica LiauwKatie GroomWessel GanzevoortChristian GluudChristopher J. D. McKinlayAndrew SharpLaura MackayChirag KariyaKen LimPeter von DadelszenJacqueline LimpensJanus C. Jakobsenthe STRIDER ConsortiumBMCarticleFetal growth restrictionPhosphodiesterase type 5 inhibitorRandomised clinical trialTrial sequential analysisAggregate meta-analysisIndividual patient data meta-analysisMedicineRENSystematic Reviews, Vol 10, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Fetal growth restriction Phosphodiesterase type 5 inhibitor Randomised clinical trial Trial sequential analysis Aggregate meta-analysis Individual patient data meta-analysis Medicine R
spellingShingle	Fetal growth restriction Phosphodiesterase type 5 inhibitor Randomised clinical trial Trial sequential analysis Aggregate meta-analysis Individual patient data meta-analysis Medicine R Jessica Liauw Katie Groom Wessel Ganzevoort Christian Gluud Christopher J. D. McKinlay Andrew Sharp Laura Mackay Chirag Kariya Ken Lim Peter von Dadelszen Jacqueline Limpens Janus C. Jakobsen the STRIDER Consortium Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis
description	Abstract Background Early onset fetal growth restriction secondary to placental insufficiency can lead to severe maternal and neonatal morbidity and mortality. Pre-clinical studies and a few small randomised clinical trials have suggested that phosphodiesterase type 5 (PDE-5) inhibitors may have protective effects against placental insufficiency in this context; however, robust evidence is lacking. The STRIDER Consortium conducted four randomised trials to investigate the use of a PDE-5 inhibitor, sildenafil, for the treatment of early onset fetal growth restriction. We present a protocol for the pre-planned systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis of these and other eligible trials. The main objective of this study will be to evaluate the effects of PDE-5 inhibitors on neonatal morbidity compared with placebo or no intervention among pregnancies with fetal growth restriction. Methods We will search the following electronic databases with no language or date restrictions: OVID MEDLINE, OVID EMBASE, the Cochrane Controlled Register of Trials (CENTRAL), and the clinical trial registers Clinicaltrials.gov and World Health Organisation International Clinical Trials Registry Platform (ICTRP). We will identify randomised trials of PDE-5 inhibitors in singleton pregnancies with growth restriction. Two reviewers will independently screen all citations, full-text articles, and abstract data. Our primary outcome will be infant survival without evidence of serious adverse neonatal outcome. Secondary outcomes will include gestational age at birth and birth weight z-scores. We will assess bias using the Cochrane Risk of Bias 2 tool. We will conduct aggregate meta-analysis using fixed and random effects models, Trial Sequential Analysis, and individual participant data meta-analysis using one- and two-stage approaches. The certainty of evidence will be assessed with GRADE. Discussion This pre-defined protocol will minimise bias during analysis and interpretation of results, toward the goal of providing robust evidence regarding the use of PDE-5 inhibitors for the treatment of early onset fetal growth restriction. Systematic review registration PROSPERO (CRD42017069688).
format	article
author	Jessica Liauw Katie Groom Wessel Ganzevoort Christian Gluud Christopher J. D. McKinlay Andrew Sharp Laura Mackay Chirag Kariya Ken Lim Peter von Dadelszen Jacqueline Limpens Janus C. Jakobsen the STRIDER Consortium
author_facet	Jessica Liauw Katie Groom Wessel Ganzevoort Christian Gluud Christopher J. D. McKinlay Andrew Sharp Laura Mackay Chirag Kariya Ken Lim Peter von Dadelszen Jacqueline Limpens Janus C. Jakobsen the STRIDER Consortium
author_sort	Jessica Liauw
title	Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis
title_short	Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis
title_full	Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis
title_fullStr	Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis
title_full_unstemmed	Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis
title_sort	short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis
publisher	BMC
publishDate	2021
url	https://doaj.org/article/79c934a25fd948e0a218890e5020aafc
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Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis

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