RecruitingPhase 3ACTRN12621000354886

Reducing operative birth for fetal distress in women with small or suboptimally grown infants - The RidStress 2 Randomised Controlled Trial


Sponsor

Mater Misericordiae Ltd

Enrollment

660 participants

Start Date

Jul 28, 2021

Study Type

Interventional

Conditions

Summary

This is a 4-year Phase 3 RCT to re-purpose sildenafil citrate - a widely available, off-patent drug that dilates pelvic blood vessels and improves placental blood flow. The trial will evaluate whether, compared to Placebo, sildenafil citrate safely reduces emergency caesarean sections for fetal distress in small or suboptimally grown babies.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

When a baby is smaller than expected (small for gestational age or growth-restricted), they are at higher risk of distress during labour — which can lead to emergency caesarean sections. This Phase 3 trial is testing whether sildenafil citrate (the active ingredient in Viagra) taken during labour can reduce the rate of emergency caesarean sections in women carrying small or growth-restricted babies. Sildenafil works by dilating blood vessels, which may improve blood flow through the placenta during the stress of labour contractions. To be eligible, you must be 18 or older, pregnant with a single baby, planning a vaginal birth at term (37 weeks or more), and your baby must be suspected to be small for gestational age or have late fetal growth restriction based on ultrasound measurements. Participants are randomly assigned to receive either sildenafil or a placebo during labour. The study is being run through Mater Misericordiae hospitals. Women taking nitrate medications, those who have had two or more previous caesareans, or those with a serious liver or kidney condition are not eligible. This research could help reduce the risks of emergency caesarean sections for both mother and baby when a small baby is identified in late pregnancy.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intrapartum Sildenafil Citrate 50mg taken orally, 8 hourly to a maximum of 3 doses (150mg) in 24 hours, given on one day only. Sildenafil Citrate will be given when the participant is admitted to t

Intrapartum Sildenafil Citrate 50mg taken orally, 8 hourly to a maximum of 3 doses (150mg) in 24 hours, given on one day only. Sildenafil Citrate will be given when the participant is admitted to the birthing unit for the commencement of induction of labour (artificial rupture of membranes +/- syntocinon infusion), or for management of spontaneous labour (regular uterine activity and >/= 4cm dilation on cervical assessment).


Locations(4)

Mater Mother's Hospital - South Brisbane

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Sunshine Coast University Hospital - Birtinya

QLD, Australia

Gold Coast University Hospital - Southport

QLD, Australia

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ACTRN12621000354886