Fetal DistressPRISMNCT05946681
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
An observational study of Fetal Distress and Perinatal Asphyxia, run by NICHD Global Network for Women's and Children's Health at 1 site in Zambia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Distress, Perinatal Asphyxia, Birth Asphyxia
- How many people
- 1,017 participants
- Where
- 1 siteZambia
- Study dates
- 16 May 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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]
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fetal Distress, Perinatal Asphyxia, Birth Asphyxia, Stillbirth
- Keywords
- Fetal Distress, Perinatal Asphyxia, Sildenafil Citrate, Fetal Heart Rate Monitoring, Zambia
- Medical subject headings
- Fetal Distress, Asphyxia Neonatorum, Stillbirth
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From delivery to 7 days post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start16 May 2023
- Primary completion30 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, RTI International
- Responsible party
- Sponsor
- Investigators
- Elwyn Chomba, MD, Principal investigator, Levy Mwanawasa Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946681
- Sponsor's protocol ID
- GN03 PRISM Sildenafil Pilot
- Acronym
- PRISM
- Status last verified
- Nov 2023
- First submitted
- 14 Jun 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
- ClinicalTrials.gov ID
- NCT05946681
- Acronym / sponsor ID
- PRISM / GN03 PRISM Sildenafil Pilot
- Conditions
- Fetal Distress, Perinatal Asphyxia, Birth Asphyxia, Stillbirth
- Keywords
- Fetal Distress, Perinatal Asphyxia, Sildenafil Citrate, Fetal Heart Rate Monitoring, Zambia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, RTI International
- Study start
- 16 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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]
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect size estimate of the intervention on the incidence of the composite neonatal outcome.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Yes
Related trials for Fetal Distress
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The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elwyn Chomba, MD principal investigator
Levy Mwanawasa Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Distress and Perinatal Asphyxia, run by NICHD Global Network for Women's and Children's Health at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect size estimate of the intervention on the incidence of the composite neonatal outcome. (time frame: From delivery to 7 days post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.