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Toolsvon Dadelszen, Peter, Audibert, François, Bujold, Emmanuel, Bone, Jeffrey N., Sandhu, Ash, Li, Jing, Kariya, Chirag, Chung, Youkee, Lee, Tang, Au, Kelvin, Skoll, M. Amanda, Vidler, Marianne, Magee, Laura A., Piedboeuf, Bruno, Baker, Philip N., Lalji, Sayrin and Lim, Kenneth I. (2022) Halting the Canadian STRIDER randomised controlled trial of sildenafil for severe, early-onset fetal growth restriction: Ethical, methodological, and pragmatic considerations. BMC Research Notes, 15. ISSN 1756-0500
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Abstract
Objectives: To 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]. Results: Between 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.
| Item Type: | Article |
|---|---|
| Additional Information: | Availability of data and materials: Data are being shared with the STRIDER IPD consortium and are available through direct contact with the STRIDER Canada Trial team at STRIDERCanada@cw.bc.ca. Funding: Support of the Canadian Institutes of Health Research (Grant Number: MOP-137077). |
| Uncontrolled Keywords: | early trial halting,fetal growth restriction,randomised controlled trial,sildenafil,biochemistry, genetics and molecular biology(all) ,/dk/atira/pure/subjectarea/asjc/1300 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 07 May 2025 15:30 |
| Last Modified: | 09 May 2025 09:30 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/99199 |
| DOI: | 10.1186/s13104-022-06107-y |
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