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

NCT05946681 | Completed DMC

• 1 other identifier: GN03 PRISM Sildenafil Pilot
• Study Type: observational
• Target: 1,017
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fetal Distress; Perinatal Asphyxia; Sildenafil Citrate; Fetal Heart Rate Monitoring; Zambia

Outcome Measures

Primary Outcomes (1)

• Effect size estimate of the intervention on the incidence of the composite neonatal outcome.

  The outcome will be measured by overall number of eligible consented participants and incidence of the composite neonatal outcome.

  From delivery to 7 days post delivery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women who are delivering in a participating health facility will be screened for eligibility
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The pilot observational study will be undertaken in two sites in Zambia; one in a Level 3 delivery facility and a Level 2 delivery facility in Lusaka. A maximum of 1000 women per site will be enrolled in the pilot study. Each site will prospectively collect up to six months of data, three months of piloting forms and non-drug interventions. A subsequent small RCT with study medication will enroll 500 participants over a period of up to three months per site. Enrollment will take place in pre-identified health facilities where women present for labor and delivery.

You may qualify if:

• Admission to facility with plan for spontaneous or induced vaginal delivery
• Early stage of labor (≤ 6 cm cervical dilation per local standard) at ≥ 37 weeks gestation
• Age ≥ 18 years of age
• Presence of single live fetus confirmed via a fetal heart rate by Doptone in cephalic position
• Provision of written informed consent \[Note: if written consent is obtained at an early time, verbal re-confirmation is required at time of enrollment\]

You may not qualify if:

• Non-emancipated minors (as per local regulations)
• Plan for Cesarean delivery or history of cesarean section prior to enrollment\*
• Unknown gestational age
• Advanced stage of labor (\>6 cm or 10 cm cervical dilation per local standards) and pushing or too distressed to understand, confirm, or give informed consent regardless of cervical dilation
• Not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum hemorrhage) or mental disorder;
• Any medical condition considered a contraindication, including contraindication to sildenafil therapy, per the judgement of site investigators
• Any maternal medical condition or status that precludes informed consent
• Recognized fetal anomaly

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Global Network for Women's and Children's Health Research: collaborator
• University of Alabama at Birmingham: collaborator
• University Teaching Hospital, Lusaka, Zambia: collaborator
• RTI International: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Fetal Distress; Asphyxia Neonatorum; Stillbirth

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes

Study Officials

• Elwyn Chomba, MD

  Levy Mwanawasa Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 14, 2023
• Study Start: May 16, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 7, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)