Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2016 Jan 14:14:15.
doi: 10.1186/s12967-016-0769-0.

Reducing the risk of fetal distress with sildenafil study (RIDSTRESS): a double-blind randomised control trial

Liam Dunn  1 , Vicki Flenady  2 , Sailesh Kumar  3   4
Affiliations
Clinical Trial

Reducing the risk of fetal distress with sildenafil study (RIDSTRESS): a double-blind randomised control trial

Liam Dunn et al. J Transl Med. .

Abstract

Background: Labour 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/design: This 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).

Conclusion: This is the first reported study evaluating the efficacy of SC on reducing the risk intrapartum fetal compromise.

Trial registration: Australian New Zealand Clinical Trial Registry ACTRN12615000319572.

PubMed Disclaimer

References

    1. Janbu T, Nesheim B. Uterine artery blood velocities during contractions in pregnancy and labour related to intrauterine pressure. Br J Obstet Gynaecol. 1987;94(12):1150–1155. doi: 10.1111/j.1471-0528.1987.tb02314.x. - DOI - PubMed
    1. Low JA, Pickersgill H, Killen H, Derrick E. The prediction and prevention of intrapartum fetal asphyxia in term pregnancies. Am J Obstet Gynecol. 2001;184(4):724–730. doi: 10.1067/mob.2001.111720. - DOI - PubMed
    1. McIntyre S, Taitz D, Keogh J, Goldsmith S, Badawi N, Blair E. A systematic review of risk factors for cerebral palsy in children born at term in developed countries. Dev Med Child Neurol. 2013;55(6):499–508. doi: 10.1111/dmcn.12017. - DOI - PubMed
    1. Bhutta ZA, Black R. Global maternal, newborn, and child health—so near and yet so far. N Engl J Med. 2013;369(23):2226–2235. doi: 10.1056/NEJMra1111853. - DOI - PubMed
    1. Prior T, Mullins E, Bennett P, Kumar S. Prediction of intrapartum fetal compromise using the cerebroumbilical ratio: a prospective observational study. Am J Obstet Gynecol. 2013;208(2):124.e1–124.e6. doi: 10.1016/j.ajog.2012.11.016. - DOI - PubMed

Publication types

Substances

LinkOut - more resources