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

NCT05946681 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1017

Last updated 2024-05-07

No results posted yet for this study

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.

Conditions

  • Fetal Distress
  • Perinatal Asphyxia
  • Birth Asphyxia
  • Stillbirth

Sponsors & Collaborators

  • Global Network for Women's and Children's Health Research

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • University Teaching Hospital, Lusaka, Zambia

    collaborator OTHER

  • RTI International

    collaborator OTHER

  • NICHD Global Network for Women's and Children's Health

    lead NETWORK

Principal Investigators

  • Elwyn Chomba, MD · Levy Mwanawasa Medical University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2023-10-30
Completion
2023-12-31

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946681 on ClinicalTrials.gov