An observational study in Fetal Distress, Perinatal Asphyxia and Birth Asphyxia, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 1 site in Zambia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by NICHD Global Network for Women's and Children's Health · Observational
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.
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:
37 studies on the registry are indexed under Fetal Distress; 7 are open to participants now.
This study's enrollment of 1,017 is above the median of 121 across 12 observational studies indexed under Fetal Distress.
Browse Fetal Distress studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The pilot observational study will be undertaken in two sites in Zambia; one in a Level 3 delivery facility and a Level 2 delivery facility in Lusaka. A maximum of 1000 women per site will be enrolled in the pilot study. Each site will prospectively collect up to six months of data, three months of piloting forms and non-drug interventions. A subsequent small RCT with study medication will enroll 500 participants over a period of up to three months per site. Enrollment will take place in pre-identified health facilities where women present for labor and delivery.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: From delivery to 7 days post delivery
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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NICHD Global Network for Women's and Children's Health