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

Completed

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

• Registration Number: NCT05946681
• Lead Sponsor: NICHD Global Network for Women's and Children's Health

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.

Study Timeline

• Study Start: 2023-05-16
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-14
• Primary Completion: 2023-10-30
• Status Verified: 2023-11
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1017

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect size estimate of the intervention on the incidence of the composite neonatal outcome.	From delivery to 7 days post delivery	The outcome will be measured by overall number of eligible consented participants and incidence of the composite neonatal outcome.

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia