Evidence map›Paper›PMID 35799272›Full record

SynthesisBMC research notes2022

Halting the Canadian STRIDER randomised controlled trial of sildenafil for severe, early-onset fetal growth restriction: ethical, methodological, and pragmatic considerations.

Peter von Dadelszen, François Audibert, Emmanuel Bujold, Jeffrey N Bone, Ash Sandhu, Jing Li, Chirag Kariya, Youkee Chung, Tang Lee, Kelvin Au and 7 more

Registry-linked trialOpen access · goldAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMC research notes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02442492 (STRIDER Canada), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02442492 phase2 / phase3terminatednot on this map

STRIDER Canada: A Randomized Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction (Canada)

TypeinterventionalSponsorUniversity of British ColumbiaRan2017 to 2019Enrolled21ConditionsIntrauterine Growth Restriction (IUGR), Fetal Growth Restriction (FGR)ArmsSildenafil, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Safety and efficacy of phosphodiesterase-5 (PDE-5) inhibitors in fetal growth restriction: a systematic literature review and meta-analysis.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2024
    Pooled it
  2. Pooled it
  3. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 5 institutions in 2 countries.

Peter von DadelszenDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK. pvd@kcl.ac.uk.ORCID http://orcid.org/0000-0003-4136-3070
François AudibertDépartement d'Obstétrique-Gynécologie, Faculté de Médecine, Université de Montréal, Montréal, QC, Canada.
Emmanuel BujoldDépartement d'Obstétrique, de Gynécologie et de Reproduction, Faculté de Médecine, Université Laval, Québec, QC, Canada.
Jeffrey N BoneDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Ash SandhuDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Jing LiDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Chirag KariyaDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Youkee ChungDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Tang LeeDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Kelvin AuDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
M Amanda SkollDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Marianne VidlerDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Laura A MageeDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
Bruno PiedboeufDépartement de Pédiatrie, Faculté de Médecine, Université Laval, Québec, QC, Canada.
Philip N BakerPro-Vice-Chancellor Research and Enterprise, University of Leicester, Leicester, UK.
Sayrin LaljiDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
Kenneth I LimDepartment of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
University of British Columbia · CAUniversité Laval · CAKing's College London · GBUniversité de Montréal · CAUniversity of Leicester · GB

Funding

CIHR MOP-137077
6 · The paper itself

Abstract

objectivesTo determine the efficacy and safety of sildenafil citrate to improve outcomes in pregnancies complicated by early-onset, dismal prognosis, fetal growth restriction (FGR). Eligibility: women ≥ 18 years, singleton, 18 + 0-27 + 6 weeks' gestation, estimated fetal weight < 700 g, low PLFG, and ≥ 1 of (i) abdominal circumference < 10th percentile for gestational age (GA); or (ii) reduced growth velocity and either abnormal uterine artery Doppler or prior early-onset FGR with adverse outcome. Ineligibility criteria included: planned termination or reversed umbilical artery end-diastolic flow. Eligibility confirmed by placental growth factor (PLGF) < 5 th percentile for GA measured post randomization. Women randomly received (1:1) either sildenafil 25 mg three times daily or matched placebo until either delivery or 31 + 6 weeks. PRIMARY OUTCOME: delivery GA. The trial stopped early when Dutch STRIDER signalled potential harm; despite distinct eligibility criteria and IRB and DSMB support to continue, because of futility. NCT02442492 [registered 13/05/2015].

resultsBetween May 2017 and June 2018, 21 (90 planned) women were randomised [10 sildenafil; 11 placebo (1 withdrawal)]. Baseline characteristics, PLGF levels, maternal and perinatal outcomes, and adverse events did not differ. Delivery GA: 26 + 6 weeks (sildenafil) vs 29 + 2 weeks (placebo); p = 0.200. Data will contribute to an individual participant data meta-analysis.

Indexed as

Fetal Growth RetardationUmbilical ArteriesCanadaFemaleGestational AgeHumansPlacenta Growth FactorPregnancyRandomized Controlled Trials as TopicSildenafil CitrateUltrasonography, PrenatalPlacenta Growth FactorSildenafil CitrateEarly trial haltingFetal growth restrictionRandomised controlled trialSildenafil

Identifiers

PMID35799272
PMCPMC9264704
OpenAlexW4284891610

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.