Could a common ED drug reduce birth emergencies?
NCT ID NCT06522854
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This pilot study aimed to see if giving sildenafil (the drug in Viagra) to women in labor could prevent fetal distress, reduce the need for emergency C-sections or forceps deliveries, and lower the risk of newborns needing breathing help. The trial planned to enroll 120 women in low-resource countries, comparing sildenafil to a placebo. However, the study was withdrawn before any participants were enrolled, so no conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sildenafil citrate (oral tablet, 50 mg)
- What this could lead to
- If this pilot works, it could point toward a simple, low-cost way to reduce emergency C-sections and newborn breathing problems in low-resource settings.
- What could go wrong
- This trial was withdrawn before enrolling anyone, so no results exist. Even if run later, it is a small feasibility study, not proof of benefit. Sildenafil can cause side effects like headache or low blood pressure.
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
-
Nov 2026
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 Hide 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 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. 2. Planned vaginal delivery and admission to health facility with clear plan for spontaneous or induced vaginal delivery 3. Maternal age ≥ 18yrs Exclusion Criteria: 1. Unknown gestational age 2. Non-cephalic fetal presentation 3. Plan for cesarean delivery prior to enrollment 4. Previous uterine scar (cesarean section and/or myomectomy) 5. 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 6. Not capable of giving consent due to other health problems, such as obstetric emergencies (i.e. antepartum hemorrhage) or mental disorder 7. Maternal contraindication to sildenafil therapy, such as hypersensitivity to nitrates or nitrites 8. Recognized major structural fetal anomaly 9. Previous randomization in the trial
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Instrumental delivery; affecting fetus are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ladoke Akintola University of Technology Teaching Hospital
Ogbomoso, Oyo State, 210271, Nigeria
-
Lagos Island Maternity Hospital
Lagos, Lagos, 101001, Nigeria
-
Mother and Child Hospital
Surulere, Lagos, 101241, Nigeria
-
University Teaching Hospital, University of Lagos
Lagos, Lagos, 102215, Nigeria
More trials for these conditions
Other studies related to the condition(s) this trial covers.