Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
NCT Number: NCT06522854
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Intrapartum Fetal Distress|Neonatal Asphyxia|Intrapartum Asphyxia|Instrumental Delivery; Affecting Fetus
Interventions: DRUG: Sildenafil 50 mg Oral Tablet|DRUG: Placebo Oral Tablet
Sponsor: University of Alabama at Birmingham
Collaborators: University of Lagos, Nigeria|Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso|Lagos State University|National Health and Medical Research Council, Australia|Mater Medical Research Institute|The University of Queensland
Sex: ALL
Age: CHILD, ADULT
Enrollment: 2000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-09-30
Locations: Lagos Island Maternity Hospital, Lagos, Lagos State, 101001, Nigeria|University Teaching Hospital, University of Lagos, Lagos, Lagos State, 102215, Nigeria|Mother and Child Hospital, Surulere, Lagos State, 101241, Nigeria|Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso, Oyo State, 210271, Nigeria

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.

Primary Outcome Measures: 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 Outcome Measures: Percentage of mothers who received fetal heart rate monitoring, Documentation of rate of heart rate monitoring, 96 hours after enrollment|Indication for fetal heart rate monitoring, Documentation of the indication for use of fetal heart rate monitoring, 96 hours after enrollment|Apgar Score, Documentation of Apgar score at 1 minute and 5 minutes (Value 0-10, with 10 meaning better outcome), 1 minute and 5 minutes after birth|Percentage of neonates with neonatal encephalopathy by Sarnat Score, Documentation of neonatal neurological exam determined by "modified Sarnat Score (no, mild, moderate, and severe"; higher score indicates more encephalopathy, 24 hours after birth|Percentage of neonates with neonatal encephalopathy by Thompson Score, Documentation of neonatal neurological exam determined by "Thompson Score (no, mild, moderate, and severe)"; higher score indicates more severe encephalopathy, 24 hours after birth|Percentage of infants with neonatal hypoxic-ischemic encephalopathy, Documentation of neonatal encephalopathy, 96 hours after enrollment|Percentage of neonates with hypoxemia, Documentation of saturations \< 95% measured by noninvasive pre/post pulse oximetry, 48 hours after birth or at discharge, if early discharge|Percentage of neonatal ICU admissions, Documentation of admission to the Neonatal Intensive Care Unit or comparable level of care, 96 hours after enrollment|Percentage of maternal rehospitalization, Maternal rehospitalization after initial discharge from the hospital assessed by telephone call to mother, 7 days|Percentage of neonatal rehospitalization, Neonatal rehospitalization after initial discharge from the hospital assessed by telephone call to mother, 7 days