Neonatal AsphyxiaPhase 3PRISMNCT06377098
Intrapartum Sildenafil in Laboring Mothers
A Phase 3 study testing Sildenafil 50 mg Oral Tablet in people with Neonatal Asphyxia and Intrapartum Fetal Distress, run by University of Alabama at Birmingham at 3 sites in 3 countries.
Trial summary
The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources. Read more about this study
- Who is it for?
- Ages 0 days to 40 years
- Conditions the study is for
- Neonatal Asphyxia, Intrapartum Fetal Distress, Development, Infant
- What is being tested?
- Sildenafil 50 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 May 2025to 30 Sep 2028
- Phase
- Phase 3
- 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 0 days to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women presenting in early labor with a term pregnancy (≥ 37 weeks gestation)
- Early labor will be defined as cervical dilation less than or equal to 6 cm
- Gestational age will be calculated from the most reliable variable using the following hierarchy of reliability: 2) gestational dating ultrasound completed at any time during the pregnancy (with preference to the earliest exam); 2) date of last menstrual period if menses are regular.
- Planned vaginal delivery and admission to health facility with clear plan for spontaneous or induced vaginal delivery
- Maternal age ≥ 18yrs or minors 14-17yrs eligible in countries where married or pregnant minors or their authorized representatives are legally permitted to give consent
- A single, live fetus in cephalic presentation confirmed prior to randomization
Who cannot join
- Unknown gestational age
- Maternal history of cesarean delivery
- 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 (i.e. antepartum hemorrhage) or mental disorder
- Maternal contraindication to sildenafil therapy, such as hypersensitivity to nitrates or nitrites
- Any medical condition considered a contraindication per the judgement of site investigators
Show all 11Show fewer
- Recognized fetal anomaly
- Any maternal medical condition or status that precludes informed consent
- Non-emancipated minors (as per local regulations
- Plan for cesarean delivery prior to enrollment
- Previous randomization in the trial
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-Resource Settings: A Randomized Pilot Feasibility Trial: Pilot Randomized Intrapartum Sildenafil in Mothers
The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.
The main questions it aims to answer are:
Read more
- What are the fetal heart rate monitoring practices in a low-resource setting?
- What are the indications for operative delivery in a low-resource?
- What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?
- What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?
Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.
Participants will:
- Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor
- Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.
- Have a neonatal neurological assessment prior to discharge
- Have phone call assessments for re-hospitalization or mortality 7 days post-delivery
- Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call
The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia.
Read the detailed description
After informed consent obtained, mother will be randomized, using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to either the treatment arm or the placebo concurrent control.
Eligible women who consent for the study will be randomized to receive sildenafil 50 mg orally every 8 hours up to a total of 3 doses or to receive the placebo every 8 hours up to a total of 3 does during the course of labor. Neither medication no placebo will be given following completion of labor. All additional care of the mother and infant will be provided according to the local standard of care. Outcomes will be collected following delivery, discharge, and 7-days post-partum. 7-day follow-up for outcomes will be obtained per a telephone call. One, two, and three year infant developmental and behavior outcome will be assessed using the Ages and Stages Questionnaire.
- Being tested
- Sildenafil 50 mg Oral Tablet, Placebo Oral Tablet
- Keywords
- Sildenafil citrate
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 50 mg Oral TabletDrug
Also called Revatio, Sildenafil
Sildenafil 50 mg given orally every eight hours up to three times while mother is in labor
Placebo Oral TabletDrug
Placebo table given orally every eight hours up to three times while mother is in labor
| Study group | Role | What they receive |
|---|---|---|
| Oral Sildenafil 50mg | Active comparator | Sildenafil citrate 50mg given orally every eight hours up to 3 doses while mother is in labor Receives: Drug: Sildenafil 50 mg Oral Tablet |
| Placebo | Placebo comparator | Identical-appearing treatment that does not contain the test drug given orally every eight hours up to 3 doses while mother is in labor Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of perinatal mortality
Documentation of stillbirth or neonatal death
Measured: 96 hours after enrollment
Percentage of operative delivery
Documentation of type of delivery
Measured: 96 hours after enrollment
Indication for operative delivery
Documentation of type of delivery
Measured: 96 hours after enrollment
Secondary outcomes (12)
Percentage of mothers who received fetal heart rate monitoring
Documentation of rate of heart rate monitoring
Measured: 96 hours after enrollment
Indication for fetal heart rate monitoring
Documentation of the indication for use of fetal heart rate monitoring
Measured: 96 hours after enrollment
Apgar Score
Documentation of Apgar score at 1 minute and 5 minutes (Value 0-10, with 10 meaning better outcome)
Measured: 1 minute and 5 minutes after birth
Percentage of use of bag and mask ventilation in neonates
Documentation of the use of bag and mask ventilation as resuscitation after delivery
Measured: 20 minutes after delivery
Percentage of neonates with neonatal encephalopathy
Documentation of neonatal neurological exam determined by "modified Sarnat Score (no, mild, moderate, and severe)" ; higher score indicates more severe encephalopathy
Measured: 24 hours after birth
Percentage of neonates with neonatal encephalopathy
Documentation of neonatal neurological exam determined by "Thompson Score (no, mild, moderate and severe)"; higher score indicates more severe encephalopathy
Measured: 24 hours after birth
Percentage of neonates with hypoxemia
Documentation of saturations < 95% measured by noninvasive pre/post pulse oximetry
Measured: 48 hours after birth or at discharge, if early discharge
Percentage of infants with neonatal hypoxic-ischemic encephalopathy
Documentation of neonatal encephalopathy
Measured: 96 hours after enrollment
Percentage of neonatal ICU admissions
Documentation of admission to the Neonatal Intensive Care Unit or comparable level of care
Measured: 96 hours after enrollment
Percentage of maternal rehospitalization
Maternal rehospitalization after initial discharge from the hospital assessed by telephone call to mother
Measured: 7 days
Percentage of neonatal rehospitalization
Neonatal rehospitalization after initial discharge from the hospital assessed by telephone call to mother
Measured: 7 days
Infant/child developmental assessment
Score on "Ages and Stages Questionnaire" obtained by telephone call to parent (developmental assessment tool which scores items (Yes=10, Sometimes=5, Not Yet=0) in areas of Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social. Scoring of items are totaled and placed on a graph indicating cutoff score. If score is above cutoff, the child's development appears to be on schedule; near the cutoff, may provide learning activities and monitor; and below cutoff, requiring further assessment. 12-month cutoffs (Communication 15.64; Gross Motor 21.49; Fine Motor 34.50; Problem Solving 27.32 and Personal-Social 21.73); 24-month cutoffs ((Communication 25.17; Gross Motor 38.07; Fine Motor 35.16; Problem Solving 29.78 and Personal-Social 31.54); and 36-month cutoffs (Communication 30.99; Gross Motor 36.99; Fine Motor 18.07; Problem Solving 30.29 and Personal-Social 35.33)
Measured: 12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2028 (estimated)
Why it stopped: Funding not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal AsphyxiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, placebo-controlled, 1:1 parallel allocation, randomized feasibility trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia, Egerton University, Cameroon Baptist Convention Health
- Responsible party
- Principal investigator, Waldemar A. Carlo, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377098
- Sponsor's protocol ID
- UAB-300010901
- Other IDs
- UAB Dixon Endowed Ch/3102800
- Acronym
- PRISM
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. 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: A Randomized Pilot Feasibility Trial: Pilot Randomized Intrapartum Sildenafil in Mothers
- ClinicalTrials.gov ID
- NCT06377098
- Acronym / sponsor ID
- PRISM / UAB-300010901
- Keywords
- Sildenafil citrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia, Egerton University, Cameroon Baptist Convention Health
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Apr 2024 (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 goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.
The main questions it aims to answer are:
- What are the fetal heart rate monitoring practices in a low-resource setting?
- What are the indications for operative delivery in a low-resource?
- What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?
- What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?
Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.
Participants will:
- Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor
- Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.
- Have a neonatal neurological assessment prior to discharge
- Have phone call assessments for re-hospitalization or mortality 7 days post-delivery
- Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call
The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia.
Detailed description
After informed consent obtained, mother will be randomized, using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to either the treatment arm or the placebo concurrent control.
Eligible women who consent for the study will be randomized to receive sildenafil 50 mg orally every 8 hours up to a total of 3 doses or to receive the placebo every 8 hours up to a total of 3 does during the course of labor. Neither medication no placebo will be given following completion of labor. All additional care of the mother and infant will be provided according to the local standard of care. Outcomes will be collected following delivery, discharge, and 7-days post-partum. 7-day follow-up for outcomes will be obtained per a telephone call. One, two, and three year infant developmental and behavior outcome will be assessed using the Ages and Stages Questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, placebo-controlled, 1:1 parallel allocation, randomized feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Oral Sildenafil 50mg | Active comparator | Drug: Sildenafil 50 mg Oral TabletSildenafil citrate 50mg given orally every eight hours up to 3 doses while mother is in labor |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletIdentical-appearing treatment that does not contain the test drug given orally every eight hours up to 3 doses while mother is in labor |
Who may qualify
- Ages
- 0 days to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pregnant women presenting in early labor with a term pregnancy (≥ 37 weeks gestation)
- Planned vaginal delivery and admission to health facility with clear plan for spontaneous or induced vaginal delivery
- Maternal age ≥ 18yrs or minors 14-17yrs eligible in countries where married or pregnant minors or their authorized representatives are legally permitted to give consent
- A single, live fetus in cephalic presentation confirmed prior to randomization
Key exclusion criteria (11 listed)
- Unknown gestational age
- Maternal history of cesarean delivery
- 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 (i.e. antepartum hemorrhage) or mental disorder
- Maternal contraindication to sildenafil therapy, such as hypersensitivity to nitrates or nitrites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil 50 mg Oral TabletAlso: Revatio, SildenafilSildenafil 50 mg given orally every eight hours up to three times while mother is in labor | Drug | Oral Sildenafil 50mg |
| Placebo Oral TabletPlacebo table given orally every eight hours up to three times while mother is in labor | Drug | Placebo |
Primary outcome
Percentage of perinatal mortality
Time frame: 96 hours after enrollment
Documentation of stillbirth or neonatal death
Percentage of operative delivery
Time frame: 96 hours after enrollment
Documentation of type of delivery
Indication for operative delivery
Time frame: 96 hours after enrollment
Documentation of type of delivery
12 secondary outcomes
Percentage of mothers who received fetal heart rate monitoring
Time frame: 96 hours after enrollment
Indication for fetal heart rate monitoring
Time frame: 96 hours after enrollment
Apgar Score
Time frame: 1 minute and 5 minutes after birth
Percentage of use of bag and mask ventilation in neonates
Time frame: 20 minutes after delivery
Percentage of neonates with neonatal encephalopathy
Time frame: 24 hours after birth
Percentage of neonates with neonatal encephalopathy
Time frame: 24 hours after birth
Percentage of neonates with hypoxemia
Time frame: 48 hours after birth or at discharge, if early discharge
Percentage of infants with neonatal hypoxic-ischemic encephalopathy
Time frame: 96 hours after enrollment
Percentage of neonatal ICU admissions
Time frame: 96 hours after enrollment
Percentage of maternal rehospitalization
Time frame: 7 days
Percentage of neonatal rehospitalization
Time frame: 7 days
Infant/child developmental assessment
Time frame: 12 months, 24 months, 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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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.
Waldemar A Carlo, MD principal investigator
University of Alabama at Birmingham
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil 50 mg Oral Tablet in people with Neonatal Asphyxia and Intrapartum Fetal Distress, run by University of Alabama at Birmingham at 3 sites in 3 countries.
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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cameroon, Kenya, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of perinatal mortality (time frame: 96 hours after enrollment). The study lists 3 primary outcomes in all. 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 16 Sep 2025.