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

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.

Study Overview

• Status: Completed
• Conditions: Perinatal Asphyxia; Stillbirth; Birth Asphyxia; Fetal Distress

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.

• Study Type: Observational
• Enrollment (Actual): 1017

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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]

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: University of Alabama at Birmingham; RTI International; University Teaching Hospital, Lusaka, Zambia; Global Network for Women's and Children's Health Research
• Investigators: Principal Investigator: Elwyn Chomba, MD, Levy Mwanawasa Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Zambia; Perinatal Asphyxia; Sildenafil Citrate; Fetal Distress; Fetal Heart Rate Monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Pregnancy Complications; Death; Fetal Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Asphyxia; Asphyxia Neonatorum; Stillbirth; Fetal Distress
• Other Study ID Numbers: GN03 PRISM Sildenafil Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No