Status:
WITHDRAWN
Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University of Lagos, Nigeria
Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso
Conditions:
Intrapartum Fetal Distress
Neonatal Asphyxia
Eligibility:
All Genders
Up to 40 years
Phase:
PHASE3
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Maternal contraindication to sildenafil therapy, such as hypersensitivity to nitrates or nitrites
- Recognized major structural fetal anomaly
- Previous randomization in the trial
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06522854
Start Date
May 1 2025
End Date
November 30 2026
Last Update
September 16 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Lagos Island Maternity Hospital
Lagos, Lagos, Nigeria, 101001
2
University Teaching Hospital, University of Lagos
Lagos, Lagos, Nigeria, 102215
3
Mother and Child Hospital
Surulere, Lagos, Nigeria, 101241
4
Ladoke Akintola University of Technology Teaching Hospital
Ogbomoso, Oyo State, Nigeria, 210271