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

NCT ID: NCT05946681

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1017 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2023-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University Teaching Hospital, Lusaka, Zambia

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

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

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elwyn Chomba, MD

Role: PRINCIPAL_INVESTIGATOR

Levy Mwanawasa Medical University

Locations

University Teaching Hospital

Lusaka, , Zambia

Countries

Zambia

Other Identifiers

GN03 PRISM Sildenafil Pilot

Identifier Type: -

Identifier Source: org_study_id