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Neurodevelopmental outcomes at 2 years in children who received sildenafil therapy in utero: The STRIDER randomised controlled trial.
Sharp, Andrew; Cornforth, Christine; Jackson, Richard; Harrold, Jane; Turner, Mark A; Kenny, Louise C; Baker, Philip N; Johnstone, Edward D; Khalil, Asma; von Dadelszen, Peter; Papageorghiou, Aris T; Alfirevic, Zarko; Vollmer, Brigitte.
Afiliación
  • Sharp A; Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
  • Cornforth C; Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK.
  • Jackson R; Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
  • Harrold J; Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.
  • Turner MA; Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.
  • Kenny LC; Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.
  • Baker PN; Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
  • Johnstone ED; Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK.
  • Khalil A; Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
  • von Dadelszen P; College of Life Sciences, University of Leicester, Leicester, UK.
  • Papageorghiou AT; Faculty of Medicine Biology and Health, Maternal and Fetal Health Research Centre, School of Medical Sciences, University of Manchester, Manchester, UK.
  • Alfirevic Z; Fetal Medicine Unit, St George's Hospital, University of London, London, UK.
  • Vollmer B; Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
BJOG ; 131(12): 1673-1683, 2024 Nov.
Article en En | MEDLINE | ID: mdl-38923115
ABSTRACT

OBJECTIVE:

Severe early-onset fetal growth restriction (FGR) causes stillbirth, neonatal death and neurodevelopmental impairment. Poor maternal spiral artery remodelling maintains vasoactive responsiveness but is susceptible to treatment with sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor, which may improve perinatal outcomes.

DESIGN:

Superiority, double-blind randomised controlled trial.

SETTING:

A total of 20 UK fetal medicine units. POPULATION Pregnancies affected by FGR, defined as an abdominal circumference below the tenth centile with absent end-diastolic flow in the umbilical artery between 22+0 and 29+6 weeks of gestation.

METHODS:

Treatment with sildenafil (25 mg three times/day) or placebo until delivery or 32 weeks of gestation. MAIN OUTCOME

MEASURES:

All infants alive at hospital discharge were assessed for cardiovascular function and cognitive, speech/language and neuromotor impairment at 2 years of age. The primary outcome was survival without cerebral palsy or neurosensory impairment, or a Bayley-III composite score of >85.

RESULTS:

In total, 135 women were randomised between November 2014 and July 2016 (70 to sildenafil and 65 to placebo). We previously published that there was no improvement in time to delivery or perinatal outcomes with sildenafil. In all, 75 babies (55.5%) were discharged alive, with 61 infants eligible for follow-up (32 sildenafil and 29 placebo). One infant died (placebo), three mothers declined and ten mothers were uncontactable. There was no difference in neurodevelopment or blood pressure following treatment with sildenafil. Infants who received sildenafil had a larger head circumference at 2 years of age (median difference 49.2 cm, IQR 46.4-50.3, vs 47.2 cm, 95% CI 44.7-48.9 cm).

CONCLUSIONS:

Sildenafil therapy did not prolong pregnancy or improve perinatal outcomes and did not improve infant neurodevelopment in FGR survivors. Therefore, sildenafil should not be prescribed for this condition.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inhibidores de Fosfodiesterasa 5 / Retardo del Crecimiento Fetal / Citrato de Sildenafil Límite: Adult / Child, preschool / Female / Humans / Infant / Male / Newborn / Pregnancy Idioma: En Revista: BJOG Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inhibidores de Fosfodiesterasa 5 / Retardo del Crecimiento Fetal / Citrato de Sildenafil Límite: Adult / Child, preschool / Female / Humans / Infant / Male / Newborn / Pregnancy Idioma: En Revista: BJOG Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido