None listed
Conditions
Brief summary
The iSEARCH Trial will determine if, in women in labour at term receiving oral 50 mg SC vs placebo given in less than or equal to 3 doses, reduces a primary composite endpoint, determined up to 28 days after birth, of ten perinatal outcomes related to intrapartum hypoxia.
Interventions
Sildenafil Citrate is the study intervention in this trial. Treatment will commence after transfer to the labour ward once in labour or for induction of labour. The dose of SC is 50mg orally or equivalent placebo every 8 hours to a maximum of three doses.
Adherence will be monitored by a study team member who will observe the administration of the study drug to the participant.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women with singleton or dichorionic twin pregnancies planning in-hospital vaginal birth at term (>37 weeks gestation). 2. Age 18 years and older. 3. Willing and able to comply with all study requirements. 4. Signed, written informed consent.
Exclusion criteria
1. A woman should not be entered if the responsible clinician or the woman are, for any medical or nonmedical reasons, reasonably certain that SC would be inappropriate for her in comparison with no treatment or some other treatment that could be offered in or outside the trial. 2. Triplets or higher order multiple births, which are generally delivered electively before term. 3. Contraindications to the investigational product SC 4. Participants who are taking any type of nitrate drug therapy or who utilize short-acting nitrate-containing medications during labour [such as sodium nitroprusside, bosentan, fosamprenavir and ritonavir combination, hepatic enzyme inhibitors CYP3A4 (including itraconazole, ketoconazole, ritonavir, cimetidine, erythromycin, saquinavir, darunavir), or hepatic enzyme substrates (CYP3A4), medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors like riociguat], due to the risk of potentially life-threatening hypotension. 5. Severe hepatic or renal impairment.
Outcome results
None listed