Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings (NCT05946681) | Clinical Trial Compass
CompletedNot Applicable
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
Zambia1,017 participantsStarted 2023-05-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect size estimate of the intervention on the incidence of the composite neonatal outcome.
Timeframe: From delivery to 7 days post delivery
Trial details
NCT IDNCT05946681
SponsorNICHD Global Network for Women's and Children's Health