A Phase 3 interventional study of Sildenafil 50 mg Oral Tablet and Placebo Oral Tablet in Neonatal Asphyxia, Intrapartum Fetal Distress and Development, Infant, sponsored by University of Alabama at Birmingham. Withdrawn at 3 sites in 3 countries. Open to participants aged 0 Days to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by University of Alabama at Birmingham · Phase 3, Interventional, and Prevention
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:
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:
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.
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.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
Browse Asphyxia Neonatorum studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant women presenting in early labor with a term pregnancy (≥ 37 weeks gestation)
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sildenafil citrate 50mg given orally every eight hours up to 3 doses while mother is in labor
Drug: Sildenafil 50 mg Oral Tablet
Identical-appearing treatment that does not contain the test drug given orally every eight hours up to 3 doses while mother is in labor
Drug: Placebo Oral Tablet
Sildenafil 50 mg given orally every eight hours up to three times while mother is in labor
Also known as: Revatio, Sildenafil
Placebo table given orally every eight hours up to three times while mother is in labor
Percentage of perinatal mortality
Documentation of stillbirth or neonatal death
Time frame: 96 hours after enrollment
Percentage of operative delivery
Documentation of type of delivery
Time frame: 96 hours after enrollment
Indication for operative delivery
Documentation of type of delivery
Time frame: 96 hours after enrollment
Percentage of mothers who received fetal heart rate monitoring
Documentation of rate of heart rate monitoring
Time frame: 96 hours after enrollment
Indication for fetal heart rate monitoring
Documentation of the indication for use of fetal heart rate monitoring
Time frame: 96 hours after enrollment
Apgar Score
Documentation of Apgar score at 1 minute and 5 minutes (Value 0-10, with 10 meaning better outcome)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hours after birth
Percentage of neonates with hypoxemia
Documentation of saturations \< 95% measured by noninvasive pre/post pulse oximetry
Time frame: 48 hours after birth or at discharge, if early discharge
Percentage of infants with neonatal hypoxic-ischemic encephalopathy
Documentation of neonatal encephalopathy
Time frame: 96 hours after enrollment
Percentage of neonatal ICU admissions
Documentation of admission to the Neonatal Intensive Care Unit or comparable level of care
Time frame: 96 hours after enrollment
Percentage of maternal rehospitalization
Maternal rehospitalization after initial discharge from the hospital assessed by telephone call to mother
Time frame: 7 days
Percentage of neonatal rehospitalization
Neonatal rehospitalization after initial discharge from the hospital assessed by telephone call to mother
Time frame: 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)
Time frame: 12 months, 24 months, 36 months
Start is estimated for May 2025; primary completion for Aug 2026, 15 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sildenafil
University of Alabama at Birmingham →