Intrapartum Fetal DistressPhase 3NCT06522854
Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
A Phase 3 study testing Sildenafil 50 mg Oral Tablet in people with Intrapartum Fetal Distress and Neonatal Asphyxia, run by University of Alabama at Birmingham at 4 sites in Nigeria.
Trial summary
The goal of this feasibility pilot clinical trial is to determine if sildenafil citrate 50mg orally, up to three times during labor, can: 1) reduce perinatal mortality and/or bag and mask ventilation at birth in planned vaginal delivery and 2) reduce the incidence of operative delivery (instrumental vaginal birth or… Read more about this study
- Who is it for?
- Ages 0 days to 40 years
- Conditions the study is for
- Intrapartum Fetal Distress, Neonatal Asphyxia, Intrapartum Asphyxia
- 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
- 4 sitesNigeria
- Study dates
- 1 May 2025to 30 Nov 2026
- 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 to 41wks 6days gestation )
- Early labor will be defined as cervical dilation less than 7cm
- 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
Who cannot join
- Unknown gestational age
- Non-cephalic fetal presentation
- Plan for cesarean delivery prior to enrollment
- Previous uterine scar (cesarean section and/or myomectomy)
- Advanced stage of labor (7 cm or greater 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
Show all 9Show fewer
- Maternal contraindication to sildenafil therapy, such as hypersensitivity to nitrates or nitrites
- Recognized major structural fetal anomaly
- Previous randomization in the trial
Trial locations and contacts
4 sites in 1 country.
Nigeria4 sites
Lagos Island Maternity Hospital
Lagos, Lagos, 101001
University Teaching Hospital, University of Lagos
Lagos, Lagos, 102215
Ladoke Akintola University of Technology Teaching Hospital
Ogbomoso, Oyo State, 210271
Mother and Child Hospital
Surulere, Lagos, 101241
About this study
Official title: Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings: A Randomized Pilot Feasibility Trial
The goal of this feasibility pilot clinical trial is to determine if sildenafil citrate 50mg orally, up to three times during labor, can: 1) reduce perinatal mortality and/or bag and mask ventilation at birth in planned vaginal delivery and 2) reduce the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress in up to four facilities of different levels of care in low-resource countries.
The main questions it aims to answer are:
Read more
Does sildenafil citrate decrease:
- the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress?
- the incidence of bag and mask ventilation?
- the incidence of perinatal mortality?
Researchers will compare sildenafil citrate to a placebo (a look-alike substance that contains no drug) to see if sildenafil works to prevent fetal distress necessitating operative delivery, bag and mask resuscitation at birth, and ultimately, perinatal mortality.
Participants will:
- Take Sildenafil 50 mg or placebo orally every eight hours during labor (up to 3 doses)
- Have the (mothers and 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
- Receive telephone call assessments for re-hospitalization or mortality 7 days post delivery
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
Pregnant women with planned vaginal deliveries will be screened for eligibility. After informed consent obtained, subjects will be randomly assigned (using computer generated, stratified randomization codes by the pharmacy) to either the treatment arm (Sildenafil citrate) or the placebo concurrent control. Clinicians, researchers, and primary caregivers will be masked. Eligible women 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. A neurological examination (Sarnat and Thompson) will be completed on the infant within 24 hours after birth. Neonatal oxygen saturation will be measured by pulse oximetry at 48 hours or discharge, whichever comes first. Outcomes will be collected following delivery, discharge, and 7-days post-partum. 7-day follow-up for outcomes will be obtained via a telephone call.
- Conditions
- Intrapartum Fetal Distress, Neonatal Asphyxia, Intrapartum Asphyxia, Instrumental Delivery; Affecting Fetus
- 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 50 mg given orally every eight hours up to three times while mother is in labor
Placebo Oral TabletDrug
Placebo tablet 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 use of bag and mask in neonates after delivery
Documentation of the use of bag and mask ventilation as resuscitation after delivery
Measured: 20 minutes after delivery
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 (10)
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 neonates with neonatal encephalopathy by Sarnat Score
Documentation of neonatal neurological exam determined by "modified Sarnat Score (no, mild, moderate, and severe"; higher score indicates more encephalopathy
Measured: 24 hours after birth
Percentage of neonates with neonatal encephalopathy by Thompson Score
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 infants with neonatal hypoxic-ischemic encephalopathy
Documentation of neonatal encephalopathy
Measured: 96 hours after enrollment
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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 May 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Nov 2026 (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 Intrapartum Fetal DistressStudies 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
- Parallel Assignment 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 of Lagos, Nigeria, Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso, Lagos State University, National Health and Medical Research Council, Australia, Mater Medical Research Institute, The University of Queensland
- 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
- NCT06522854
- Sponsor's protocol ID
- UAB-300012809
- Other IDs
- Dixon Endow Chair/3102800
- Status last verified
- Sep 2025
- First submitted
- 22 Jul 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
- Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings: A Randomized Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT06522854
- Acronym / sponsor ID
- UAB-300012809
- Conditions
- Intrapartum Fetal Distress, Neonatal Asphyxia, Intrapartum Asphyxia, Instrumental Delivery; Affecting Fetus
- 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 of Lagos, Nigeria, Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso, Lagos State University, National Health and Medical Research Council, Australia, Mater Medical Research Institute, The University of Queensland
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Jul 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 determine if sildenafil citrate 50mg orally, up to three times during labor, can: 1) reduce perinatal mortality and/or bag and mask ventilation at birth in planned vaginal delivery and 2) reduce the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress in up to four facilities of different levels of care in low-resource countries.
The main questions it aims to answer are:
Does sildenafil citrate decrease:
- the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress?
- the incidence of bag and mask ventilation?
- the incidence of perinatal mortality?
Researchers will compare sildenafil citrate to a placebo (a look-alike substance that contains no drug) to see if sildenafil works to prevent fetal distress necessitating operative delivery, bag and mask resuscitation at birth, and ultimately, perinatal mortality.
Participants will:
- Take Sildenafil 50 mg or placebo orally every eight hours during labor (up to 3 doses)
- Have the (mothers and 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
- Receive telephone call assessments for re-hospitalization or mortality 7 days post delivery
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
Pregnant women with planned vaginal deliveries will be screened for eligibility. After informed consent obtained, subjects will be randomly assigned (using computer generated, stratified randomization codes by the pharmacy) to either the treatment arm (Sildenafil citrate) or the placebo concurrent control. Clinicians, researchers, and primary caregivers will be masked. Eligible women 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. A neurological examination (Sarnat and Thompson) will be completed on the infant within 24 hours after birth. Neonatal oxygen saturation will be measured by pulse oximetry at 48 hours or discharge, whichever comes first. Outcomes will be collected following delivery, discharge, and 7-days post-partum. 7-day follow-up for outcomes will be obtained via a telephone call.
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
- Parallel Assignment 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 (5 listed)
- Pregnant women presenting in early labor with a term pregnancy (≥ 37 weeks to 41wks 6days gestation )
- Planned vaginal delivery and admission to health facility with clear plan for spontaneous or induced vaginal delivery
- Maternal age ≥ 18yrs
Key exclusion criteria (9 listed)
- Unknown gestational age
- Non-cephalic fetal presentation
- Plan for cesarean delivery prior to enrollment
- Previous uterine scar (cesarean section and/or myomectomy)
- Advanced stage of labor (7 cm or greater cervical dilation per local standards) and pushing, or too distressed to understand, confirm, or give informed consent regardless of cervical dilation
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: RevatioSildenafil 50 mg given orally every eight hours up to three times while mother is in labor | Drug | Oral Sildenafil 50mg |
| Placebo Oral TabletPlacebo tablet 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 use of bag and mask in neonates after delivery
Time frame: 20 minutes after delivery
Documentation of the use of bag and mask ventilation as resuscitation after delivery
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
10 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 neonates with neonatal encephalopathy by Sarnat Score
Time frame: 24 hours after birth
Percentage of neonates with neonatal encephalopathy by Thompson Score
Time frame: 24 hours after birth
Percentage of infants with neonatal hypoxic-ischemic encephalopathy
Time frame: 96 hours after enrollment
Percentage of neonates with hypoxemia
Time frame: 48 hours after birth or at discharge, if early discharge
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
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.
Related trials for Intrapartum Fetal Distress
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
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
4 sites in 1 country: 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 Intrapartum Fetal Distress and Neonatal Asphyxia, run by University of Alabama at Birmingham at 4 sites in Nigeria.
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 9 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 4 sites in Nigeria. 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 4 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.