Viagra for safer births? withdrawn trial leaves questions unanswered

NCT ID NCT06377098

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study planned to give sildenafil (the drug in Viagra) to women in labor in low-resource areas, aiming to reduce fetal distress and birth asphyxia. It was designed to test whether the drug could be safely given and to gather data for a larger trial. However, the study was withdrawn before any participants were enrolled, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Sildenafil (the active ingredient in Viagra, given as 50 mg oral tablets during labor)
What this could lead to: If it had worked, this could have pointed toward a simple, low-cost way to reduce birth complications like oxygen deprivation in newborns.
What could go wrong: The trial was withdrawn before enrolling anyone, so no data exist. Even if conducted, it was a small pilot study, so results would be preliminary and might not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

May 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 days to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Planned vaginal delivery and admission to health facility with clear plan for spontaneous or induced vaginal delivery 3. 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 4. A single, live fetus in cephalic presentation confirmed prior to randomization Exclusion Criteria: 1. Unknown gestational age 2. Maternal history of cesarean delivery 3. 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 4. Not capable of giving consent due to other health problems, such as obstetric emergencies (i.e. antepartum hemorrhage) or mental disorder 5. Maternal contraindication to sildenafil therapy, such as hypersensitivity to nitrates or nitrites 6. Any medical condition considered a contraindication per the judgement of site investigators 7. Recognized fetal anomaly 8. Any maternal medical condition or status that precludes informed consent 9. Non-emancipated minors (as per local regulations 10. Plan for cesarean delivery prior to enrollment 11. Previous randomization in the trial

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Conditions

The condition(s) this trial relates to.

perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Development, infant Intrapartum asphyxia Intrapartum fetal distress Neonatal asphyxia

Viagra for safer births? withdrawn trial leaves questions unanswered

What the study statuses mean