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

NCT ID: NCT06522854

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-11-30

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. 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.

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 codes by the pharmacy) to either the treatment arm (Sildenafil citrate) or the placebo concurrent control. Clinicians, researchers, and primary caregivers will be masked. Eligible women will be randomized to receive sildenafil 50 mg orally every 8 hours up to a total of 3 doses or to receive the placebo every 8 hours up to a total of 3 does during the course of labor. Neither medication no placebo will be given following completion of labor. All additional care of the mother and infant will be provided according to the local standard of care. A neurological examination (Sarnat and Thompson) will be completed on the infant within 24 hours after birth. Neonatal oxygen saturation will be measured by pulse oximetry at 48 hours or discharge, whichever comes first. Outcomes will be collected following delivery, discharge, and 7-days post-partum. 7-day follow-up for outcomes will be obtained via a telephone call.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Sildenafil 50mg

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

Group Type: ACTIVE_COMPARATOR

Sildenafil 50 mg Oral Tablet

Intervention Type: DRUG

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

Placebo

Identical-appearing treatment that does not contain the test drug given orally every eight hours up to 3 doses while mother is in labor

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

Interventions

Sildenafil 50 mg Oral Tablet

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

Intervention Type: DRUG

Placebo Oral Tablet

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

Intervention Type: DRUG

Other Intervention Names

Revatio

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lagos, Nigeria

OTHER

Sponsor Role: collaborator

Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso

OTHER

Sponsor Role: collaborator

Lagos State University

OTHER

Sponsor Role: collaborator

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Mater Medical Research Institute

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Waldemar A. Carlo

Edwin M. Dixon Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waldemar A Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Lagos Island Maternity Hospital

Lagos, Lagos, Nigeria

University Teaching Hospital, University of Lagos

Lagos, Lagos, Nigeria

Mother and Child Hospital

Surulere, Lagos, Nigeria

Ladoke Akintola University of Technology Teaching Hospital

Ogbomoso, Oyo State, Nigeria

Countries

Nigeria

Other Identifiers

Dixon Endow Chair/3102800

Identifier Type: OTHER

Identifier Source: secondary_id

UAB-300012809

Identifier Type: -

Identifier Source: org_study_id