NCT05946681

Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,017 (actual)
• Sponsor: NICHD Global Network for Women's and Children's Health · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of the intervention and expected enrollment rates, and estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource settings in preparation for the main RCT.

Detailed description

The primary objectives of the PRISM pilot study relate to feasibility of a large randomized controlled trial of intrapartum sildenafil citrate and will aid in design of a definitive trial among pregnant women to day 42 postpartum (pp) and their newborns to day 28 pp. The pilot will help prepare for the main trial by allowing the investigators to: * Determine the rate and indication for fetal heart rate monitoring practices; * Determine the rate and indications for operative delivery; * Inform the rates of relevant primary and secondary outcomes to possibly target in a large randomized controlled trial of intrapartum sildenafil citrate; * Assess the feasibility and acceptability of the intervention and expected enrollment rates; * Estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource setting.

Conditions

• Fetal Distress
• Perinatal Asphyxia
• Birth Asphyxia
• Stillbirth

Timeline

• Start date: 2023-05-16
• Primary completion: 2023-10-30
• Completion: 2023-12-31
• First posted: 2023-07-14
• Last updated: 2024-05-07

Locations

1 site across 1 country: Zambia