CompletedPhase 3ACTRN12621000231842

Can Intrapartum SildEnafil safely Avert the Risks of Contraction-induced Hypoxia?

Can intrapartum Sildenafil Citrate safely avert the risks of contraction-induced hypoxia in labour? iSEARCH – a pragmatic multicentre Phase III randomised controlled trial.

Sponsor

The University of Sydney

Enrollment

3,200 participants

Start Date

Sep 6, 2021

Study Type

Interventional

Conditions

Contraction-induced hypoxia in labour

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.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria4

Women with singleton or dichorionic twin pregnancies planning in-hospital vaginal birth at term (>37 weeks gestation).
Age 18 years and older.
Willing and able to comply with all study requirements.
Signed, written informed consent.

Exclusion Criteria5

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.
Triplets or higher order multiple births, which are generally delivered electively before term.
Contraindications to the investigational product SC
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.
Severe hepatic or renal impairment.

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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.