Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings

NCT06522854 | Withdrawn Phase 3

• 2 other identifiers: UAB-300012809Dixon Endow Chair/3102800
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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 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:

1. 1.the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress?
2. 2.the incidence of bag and mask ventilation?
3. 3.the incidence of perinatal mortality?
4. 4.Take Sildenafil 50 mg or placebo orally every eight hours during labor (up to 3 doses)
5. 5.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.
6. 6.Have a neonatal neurological assessment prior to discharge
7. 7.Receive telephone call assessments for re-hospitalization or mortality 7 days post delivery

Conditions

Intrapartum Fetal Distress; Neonatal Asphyxia; Intrapartum Asphyxia; Instrumental Delivery; Affecting Fetus

Keywords

Sildenafil citrate

Outcome Measures

Primary Outcomes (4)

• Percentage of perinatal mortality

  Documentation of stillbirth or neonatal death

  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

  20 minutes after delivery

• Percentage of operative delivery

  Documentation of type of delivery

  96 hours after enrollment

• Indication for operative delivery

  Documentation of type of delivery

  96 hours after enrollment

Secondary Outcomes (10)

• Percentage of mothers who received fetal heart rate monitoring

  96 hours after enrollment

• Indication for fetal heart rate monitoring

  96 hours after enrollment

• Apgar Score

  1 minute and 5 minutes after birth

• Percentage of neonates with neonatal encephalopathy by Sarnat Score

  24 hours after birth

• Percentage of neonates with neonatal encephalopathy by Thompson Score

  24 hours after birth

Study Arms (2)

Oral Sildenafil 50mg

ACTIVE COMPARATOR

Sildenafil citrate 50mg given orally every eight hours up to 3 doses while mother is in labor

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

Drug: Placebo Oral Tablet

Interventions

Sildenafil 50 mg Oral Tablet DRUG

Sildenafil 50 mg given orally every eight hours up to three times while mother is in labor

Also known as: Revatio

Oral Sildenafil 50mg

Placebo Oral Tablet DRUG

Placebo tablet given orally every eight hours up to three times while mother is in labor

Placebo

Eligibility Criteria

• Age: 0 Days - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Lagos, Nigeria: collaborator
• Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso: collaborator
• Lagos State University: collaborator
• National Health and Medical Research Council, Australia: collaborator
• Mater Medical Research Institute: collaborator
• The University of Queensland: collaborator

Study Sites (4)

Lagos Island Maternity Hospital

Lagos, Lagos, 101001, Nigeria

Location

University Teaching Hospital, University of Lagos

Lagos, Lagos, 102215, Nigeria

Location

Mother and Child Hospital

Surulere, Lagos, 101241, Nigeria

Location

Ladoke Akintola University of Technology Teaching Hospital

Ogbomoso, Oyo State, 210271, Nigeria

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Sildenafil Citrate; Tablets

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator and Outcomes Assessor) The only unmasked person will be the pharmacist who dispenses the study medication--sildenafil 50 mg or identical placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edwin M. Dixon Professor of Pediatrics

Model Details: Parallel Assignment Double blinded, placebo controlled, 1:1 parallel allocation, randomized feasibility trial

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

NG (4)