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

Stillbirth Clinical Trial

— PRISM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946681
• Other study ID #: GN03 PRISM Sildenafil Pilot
• Status: Completed
• Start date: May 16, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1017
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Fetal Distress
• Perinatal Asphyxia
• Stillbirth

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (5)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health	Global Network for Women's and Children's Health Research, RTI International, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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