Phase III, randomized, double‑blind, multicenter clinical trial to evaluate the efficacy of sildenafil citrate in reducing adverse perinatal events during labour in small‑for‑gestational‑age fetuses
interventional
N/A
1 country
4
To evaluate the efficacy of sildenafil citrate administered during labour in pregnant individuals carrying small‑for‑gestational‑age fetuses (estimated fetal weight below the 10th percentile) in reducing adverse perinatal outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2026
Actual (reported)1. Adverse neonatal outcome: - Instrumental delivery - Emergency caesarean section due to risk of fetal well being - Fetal or early neonatal death (up to 7 days of life) - Meconium aspiration - Neonatal acidosis (pH <7.0 and base excess greater than –12 mEq/L) - Apgar score at 5 minutes <7 - Admission to the Neonatal Unit
- Mean uterine artery PI at the onset of labour - Umbilical artery PI at the onset of labour - Middle cerebral artery PI at the onset of labour - Adverse perinatal outcome variables (neonatal): · Neonatal birth weight · Neonatal morbidity
- Uterine artery PI at the onset and end of labour - Umbilical artery PI at the onset and end of labour - Middle cerebral artery PI at the onset and end of labour
- Neonatal morbidity - MAIN Score
- Preeclampsia - Severe preeclampsia - Eclampsia - Postpartum haemorrhage - Serious adverse events
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Formulated product
Sildenafilo Almus 50 mg comprimidos recubiertos con película EFG
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Sildenafilo Almus 50 mg comprimidos recubiertos con película EFG
Named ingredient: Sildenafil
View registry recordHospital De La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, 08950, Spain
Hospital Clinic De Barcelona
Barcelona, 08036, Spain
Clinical Trial Unit
First Submitted
July 16, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
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Hospital Universitario De Cruces
Barakaldo, 48903, Spain