Trial reportJournal of translational medicine2016
Reducing the risk of fetal distress with sildenafil study (RIDSTRESS): a double-blind randomised control trial.
Trial report in Journal of translational medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Acute tocolysis for uterine tachysystole or suspected fetal distress.The Cochrane database of systematic reviews · 2018Pooled it
- Sildenafil during the 2nd and 3rd Trimester of Pregnancy: Trials and Tribulations.International journal of environmental research and public health · 2022Review
- Analysis of Factors Associated With Variability and Acidosis of the Umbilical Artery pH at Birth.Frontiers in pediatrics · 2021Article
- Does Pentaerytrithyltetranitrate reduce fetal growth restriction in pregnancies complicated by uterine mal-perfusion? Study protocol of the PETN-study: a randomized controlled multicenter-trial.BMC pregnancy and childbirth · 2019Article
- Anesthetic Treatment of Cardiac Disease During Pregnancy.Current treatment options in cardiovascular medicine · 2018Review
- Dose Sildenafil Citrate Reduce the Incidence of Emergency Cesarean Section and Fetal Distress During Labor? A Randomized Double-Blinded Clinical Trial.Journal of reproduction & infertilityArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLabour is perhaps the most hazardous time in pregnancy. As many as 20 % of cerebral palsy cases in term infants result from intrapartum events and up to 63 % of babies who develop intrapartum compromise have no prior risk factors. Sildenafil citrate (SC), a phosphodiesterase 5 inhibitor, improves uterine blood supply through vasodilatation and potentially could improve placental perfusion and hence reduce the risk of intrapartum fetal hypoxia. The aim of this study is to evaluate the efficacy of SC to reduce the risk of intrapartum fetal compromise and the need for emergency operative delivery. METHODS/
designThis is a single centre, double-blind, randomised, phase II clinical trial of SC or placebo given during labour to women (18-50 years of age) with a single, appropriately grown, non-anomalous baby at term (37-42 weeks gestation). Those with cardiovascular, renal, hepatic, ocular or hypertensive disease or contraindication to SC will be excluded. Participants will be randomised to either SC 50 mg or placebo capsules eight hourly (SC maximum 150 mg) to commence when admitted to birth suite for management of labour. Within 3 h of the first dose, a repeat ultrasound scan will be performed to measure any changes in uteroplacental and fetal Doppler indices. Labour will continue otherwise in accordance with hospital clinical guidelines. The primary outcome is emergency caesarean section for intrapartum fetal compromise. Secondary outcomes include the effect of SC on fetal and uteroplacental blood flow, meconium liquor, fetal heart rate abnormalities and neonatal outcomes (admission to neonatal intensive care, Apgar <7 at 5 min, cord pH <7.1 or lactate >4.0 mmol/L, neonatal encephalopathy, death).
conclusionThis is the first reported study evaluating the efficacy of SC on reducing the risk intrapartum fetal compromise.
trial registrationAustralian New Zealand Clinical Trial Registry ACTRN12615000319572.
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Registered trials
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