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

Phase 3

Recruiting

• Conditions: Contraction-induced hypoxia in labour; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12621000231842
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-04
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 3200

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Outcome of:<br>a) Intrapartum Stillbirth <br>b) 28 Day Neonatal Death <br>c) Apgar Score <4 at 5 minutes <br>d) Cord Artery pH <7.0 <br>e) Neonatal Encephalopathy <br>f) Neonatal seizures <br>g) Neonatal respiratory support >4h <br>h) Neonatal unit (Special Care or Intensive Care) admission lasting >48<br>i) Persistent pulmonary hypertension of the newborn <br>j) Meconium aspiration <br><br>Primary outcome data will be collected through standard of care and study assessments documented in participant source notes (including medical records). [ Primary Outcomes a), d), j): At delivery<br>Primary Outcomes b), e), f): At any time between delivery and 28 days post delivery <br>Primary Outcomes g), h), i): At any time between delivery and discharge from the Neonatal unit<br>Primary Outcome c): Between delivery and 5 mins post delivery <br><br>Composite outcomes will be assessed together at study completion.]