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

Sponsor

NICHD Global Network for Women's and Children's Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05946681

Collaborator

Global Network for Women's and Children's Health Research (Other), University of Alabama at Birmingham (Other), University Teaching Hospital, Lusaka, Zambia (Other), RTI International (Other)

1,000

Enrollment

Location

3.5

Anticipated Duration (Months)

284.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Distress Perinatal Asphyxia Birth Asphyxia Stillbirth

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

May 16, 2023

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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