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

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. the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress?
2. the incidence of bag and mask ventilation?
3. 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:

1. Take Sildenafil 50 mg or placebo orally every eight hours during labor (up to 3 doses)
2. 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.
3. Have a neonatal neurological assessment prior to discharge
4. 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.

Conditions

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

Interventions

DRUG

Sildenafil 50 mg Oral Tablet

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

DRUG

Placebo Oral Tablet

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

Sponsors & Collaborators

• University of Lagos, Nigeria

  collaborator OTHER

• Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso

  collaborator OTHER

• Lagos State University

  collaborator OTHER

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Mater Medical Research Institute

  collaborator OTHER

• The University of Queensland

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Waldemar A Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2026-05-31

Completion

2026-11-30

Countries

• Nigeria

Study Locations