STRIDER NZAus: A multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction

Katie M Groom, Lesley M Mccowan, Laura K Mackay, Arier C Lee, Glenn Gardener, Julia Unterscheider, Renuka Sekar, Jan E Dickinson, Peter Muller, Rosemary A Reid, David Watson, Alec Welsh, Jay Marlow, Susan P Walker, Jon Hyett, Jonathan Morris, Peter R Stone, Philip N Baker

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: To assess the effect of maternal sildenafil therapy on fetal growth in pregnancies with early-onset fetal growth restriction.

DESIGN: A randomised placebo-controlled trial.

SETTING: Thirteen maternal-fetal medicine units across New Zealand and Australia.

POPULATION: Women with singleton pregnancies affected by fetal growth restriction at 22+0 to 29+6 weeks.

METHODS: Women were randomised to oral 25mg sildenafil citrate or visually matching placebo three times daily until 32+0 weeks, birth or fetal death (whichever occurred first).

MAIN OUTCOME MEASURES: The primary outcome was the proportion of pregnancies with an increase in fetal growth velocity. Secondary outcomes included livebirth, survival to hospital discharge free of major neonatal morbidity and preeclampsia.

RESULTS: Sildenafil did not affect the proportion of pregnancies with an increase in fetal growth velocity; 32/61 (52.5%) sildenafil-treated 39/57 (68.4%) placebo-treated, adjusted OR 0.49, 95% CI 0.23-1.05 and had no effect on abdominal circumference Z-scores (p=0.61). Sildenafil use was associated with a lower mean uterine pulsatility index after 48 hours treatment (1.56 vs 1.81 p=0.02). The livebirth rate was 56/63 (88.9%) sildenafil-treated 47/59 (79.7%) placebo-treated, adjusted OR 2.50 (95%CI 0.80-7.79); survival to hospital discharge free of major neonatal morbidity was 42/63 (66.7%) sildenafil-treated 33/59 (55.9%) placebo-treated, adjusted OR 1.93 (0.84-4.45); and new-onset preeclampsia was 9/51 (17.7%) sildenafil-treated and 14/55 (25.5%) placebo-treated, OR 0.67 (95%CI 0.26-1.75).

CONCLUSIONS: Maternal sildenafil use had no effect on fetal growth velocity. Prospectively planned meta-analyses will determine whether sildenafil exerts other effects on maternal and fetal/neonatal wellbeing. This article is protected by copyright. All rights reserved.

Original languageEnglish
Pages (from-to)997-1006
Number of pages10
JournalBJOG : an international journal of obstetrics and gynaecology
Volume126
Issue number8
Early online date19 Feb 2019
DOIs
Publication statusPublished - Jul 2019

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Fetal Development
Randomized Controlled Trials
Placebos
Mothers
Therapeutics
Pregnancy
Pre-Eclampsia
Sildenafil Citrate
Morbidity
Fetal Death
Survival
New Zealand
Meta-Analysis
Medicine
Parturition

Cite this

Groom, Katie M ; Mccowan, Lesley M ; Mackay, Laura K ; Lee, Arier C ; Gardener, Glenn ; Unterscheider, Julia ; Sekar, Renuka ; Dickinson, Jan E ; Muller, Peter ; Reid, Rosemary A ; Watson, David ; Welsh, Alec ; Marlow, Jay ; Walker, Susan P ; Hyett, Jon ; Morris, Jonathan ; Stone, Peter R ; Baker, Philip N. / STRIDER NZAus : A multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction. In: BJOG : an international journal of obstetrics and gynaecology. 2019 ; Vol. 126, No. 8. pp. 997-1006.
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title = "STRIDER NZAus: A multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction",
abstract = "OBJECTIVE: To assess the effect of maternal sildenafil therapy on fetal growth in pregnancies with early-onset fetal growth restriction.DESIGN: A randomised placebo-controlled trial.SETTING: Thirteen maternal-fetal medicine units across New Zealand and Australia.POPULATION: Women with singleton pregnancies affected by fetal growth restriction at 22+0 to 29+6 weeks.METHODS: Women were randomised to oral 25mg sildenafil citrate or visually matching placebo three times daily until 32+0 weeks, birth or fetal death (whichever occurred first).MAIN OUTCOME MEASURES: The primary outcome was the proportion of pregnancies with an increase in fetal growth velocity. Secondary outcomes included livebirth, survival to hospital discharge free of major neonatal morbidity and preeclampsia.RESULTS: Sildenafil did not affect the proportion of pregnancies with an increase in fetal growth velocity; 32/61 (52.5{\%}) sildenafil-treated 39/57 (68.4{\%}) placebo-treated, adjusted OR 0.49, 95{\%} CI 0.23-1.05 and had no effect on abdominal circumference Z-scores (p=0.61). Sildenafil use was associated with a lower mean uterine pulsatility index after 48 hours treatment (1.56 vs 1.81 p=0.02). The livebirth rate was 56/63 (88.9{\%}) sildenafil-treated 47/59 (79.7{\%}) placebo-treated, adjusted OR 2.50 (95{\%}CI 0.80-7.79); survival to hospital discharge free of major neonatal morbidity was 42/63 (66.7{\%}) sildenafil-treated 33/59 (55.9{\%}) placebo-treated, adjusted OR 1.93 (0.84-4.45); and new-onset preeclampsia was 9/51 (17.7{\%}) sildenafil-treated and 14/55 (25.5{\%}) placebo-treated, OR 0.67 (95{\%}CI 0.26-1.75).CONCLUSIONS: Maternal sildenafil use had no effect on fetal growth velocity. Prospectively planned meta-analyses will determine whether sildenafil exerts other effects on maternal and fetal/neonatal wellbeing. This article is protected by copyright. All rights reserved.",
author = "Groom, {Katie M} and Mccowan, {Lesley M} and Mackay, {Laura K} and Lee, {Arier C} and Glenn Gardener and Julia Unterscheider and Renuka Sekar and Dickinson, {Jan E} and Peter Muller and Reid, {Rosemary A} and David Watson and Alec Welsh and Jay Marlow and Walker, {Susan P} and Jon Hyett and Jonathan Morris and Stone, {Peter R} and Baker, {Philip N}",
year = "2019",
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doi = "10.1111/1471-0528.15658",
language = "English",
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Groom, KM, Mccowan, LM, Mackay, LK, Lee, AC, Gardener, G, Unterscheider, J, Sekar, R, Dickinson, JE, Muller, P, Reid, RA, Watson, D, Welsh, A, Marlow, J, Walker, SP, Hyett, J, Morris, J, Stone, PR & Baker, PN 2019, 'STRIDER NZAus: A multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction' BJOG : an international journal of obstetrics and gynaecology, vol. 126, no. 8, pp. 997-1006. https://doi.org/10.1111/1471-0528.15658

STRIDER NZAus : A multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction. / Groom, Katie M; Mccowan, Lesley M; Mackay, Laura K; Lee, Arier C; Gardener, Glenn; Unterscheider, Julia; Sekar, Renuka; Dickinson, Jan E; Muller, Peter; Reid, Rosemary A; Watson, David; Welsh, Alec; Marlow, Jay; Walker, Susan P; Hyett, Jon; Morris, Jonathan; Stone, Peter R; Baker, Philip N.

In: BJOG : an international journal of obstetrics and gynaecology, Vol. 126, No. 8, 07.2019, p. 997-1006.

Research output: Contribution to journalArticle

TY - JOUR

T1 - STRIDER NZAus

T2 - A multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction

AU - Groom, Katie M

AU - Mccowan, Lesley M

AU - Mackay, Laura K

AU - Lee, Arier C

AU - Gardener, Glenn

AU - Unterscheider, Julia

AU - Sekar, Renuka

AU - Dickinson, Jan E

AU - Muller, Peter

AU - Reid, Rosemary A

AU - Watson, David

AU - Welsh, Alec

AU - Marlow, Jay

AU - Walker, Susan P

AU - Hyett, Jon

AU - Morris, Jonathan

AU - Stone, Peter R

AU - Baker, Philip N

PY - 2019/7

Y1 - 2019/7

N2 - OBJECTIVE: To assess the effect of maternal sildenafil therapy on fetal growth in pregnancies with early-onset fetal growth restriction.DESIGN: A randomised placebo-controlled trial.SETTING: Thirteen maternal-fetal medicine units across New Zealand and Australia.POPULATION: Women with singleton pregnancies affected by fetal growth restriction at 22+0 to 29+6 weeks.METHODS: Women were randomised to oral 25mg sildenafil citrate or visually matching placebo three times daily until 32+0 weeks, birth or fetal death (whichever occurred first).MAIN OUTCOME MEASURES: The primary outcome was the proportion of pregnancies with an increase in fetal growth velocity. Secondary outcomes included livebirth, survival to hospital discharge free of major neonatal morbidity and preeclampsia.RESULTS: Sildenafil did not affect the proportion of pregnancies with an increase in fetal growth velocity; 32/61 (52.5%) sildenafil-treated 39/57 (68.4%) placebo-treated, adjusted OR 0.49, 95% CI 0.23-1.05 and had no effect on abdominal circumference Z-scores (p=0.61). Sildenafil use was associated with a lower mean uterine pulsatility index after 48 hours treatment (1.56 vs 1.81 p=0.02). The livebirth rate was 56/63 (88.9%) sildenafil-treated 47/59 (79.7%) placebo-treated, adjusted OR 2.50 (95%CI 0.80-7.79); survival to hospital discharge free of major neonatal morbidity was 42/63 (66.7%) sildenafil-treated 33/59 (55.9%) placebo-treated, adjusted OR 1.93 (0.84-4.45); and new-onset preeclampsia was 9/51 (17.7%) sildenafil-treated and 14/55 (25.5%) placebo-treated, OR 0.67 (95%CI 0.26-1.75).CONCLUSIONS: Maternal sildenafil use had no effect on fetal growth velocity. Prospectively planned meta-analyses will determine whether sildenafil exerts other effects on maternal and fetal/neonatal wellbeing. This article is protected by copyright. All rights reserved.

AB - OBJECTIVE: To assess the effect of maternal sildenafil therapy on fetal growth in pregnancies with early-onset fetal growth restriction.DESIGN: A randomised placebo-controlled trial.SETTING: Thirteen maternal-fetal medicine units across New Zealand and Australia.POPULATION: Women with singleton pregnancies affected by fetal growth restriction at 22+0 to 29+6 weeks.METHODS: Women were randomised to oral 25mg sildenafil citrate or visually matching placebo three times daily until 32+0 weeks, birth or fetal death (whichever occurred first).MAIN OUTCOME MEASURES: The primary outcome was the proportion of pregnancies with an increase in fetal growth velocity. Secondary outcomes included livebirth, survival to hospital discharge free of major neonatal morbidity and preeclampsia.RESULTS: Sildenafil did not affect the proportion of pregnancies with an increase in fetal growth velocity; 32/61 (52.5%) sildenafil-treated 39/57 (68.4%) placebo-treated, adjusted OR 0.49, 95% CI 0.23-1.05 and had no effect on abdominal circumference Z-scores (p=0.61). Sildenafil use was associated with a lower mean uterine pulsatility index after 48 hours treatment (1.56 vs 1.81 p=0.02). The livebirth rate was 56/63 (88.9%) sildenafil-treated 47/59 (79.7%) placebo-treated, adjusted OR 2.50 (95%CI 0.80-7.79); survival to hospital discharge free of major neonatal morbidity was 42/63 (66.7%) sildenafil-treated 33/59 (55.9%) placebo-treated, adjusted OR 1.93 (0.84-4.45); and new-onset preeclampsia was 9/51 (17.7%) sildenafil-treated and 14/55 (25.5%) placebo-treated, OR 0.67 (95%CI 0.26-1.75).CONCLUSIONS: Maternal sildenafil use had no effect on fetal growth velocity. Prospectively planned meta-analyses will determine whether sildenafil exerts other effects on maternal and fetal/neonatal wellbeing. This article is protected by copyright. All rights reserved.

U2 - 10.1111/1471-0528.15658

DO - 10.1111/1471-0528.15658

M3 - Article

VL - 126

SP - 997

EP - 1006

JO - BJOG: an International Journal of Obstetrics and Gynecology

JF - BJOG: an International Journal of Obstetrics and Gynecology

SN - 1470-0328

IS - 8

ER -