protocolSection identificationModule nctId: NCT06377098, orgStudyIdInfo id: UAB-300010901, secondaryIdInfos id: UAB Dixon Endowed Ch/3102800, type: OTHER_GRANT, domain: UAB Dixon Endowed Chair, briefTitle: Intrapartum Sildenafil in Laboring Mothers, acronym: PRISM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: University Teaching Hospital, Lusaka, Zambia, collaborators name: Egerton University, collaborators name: Cameroon Baptist Convention Health, descriptionModule briefSummary: The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.The main questions it aims to answer are:* What are the fetal heart rate monitoring practices in a low-resource setting?* What are the indications for operative delivery in a low-resource?* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.Participants will:* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor* Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.* Have a neonatal neurological assessment prior to discharge* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone callThe 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., conditionsModule conditions: Neonatal Asphyxia, conditions: Intrapartum Fetal Distress, conditions: Development, Infant, conditions: Intrapartum Asphyxia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blinded, placebo-controlled, 1:1 parallel allocation, randomized feasibility trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The only person who will be unmasked will be the pharmacist who will dispense the study medication--either sildenafil 50mg or identical placebo, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Sildenafil 50 mg Oral Tablet, interventions name: Placebo Oral Tablet, outcomesModule primaryOutcomes measure: Percentage of perinatal mortality, primaryOutcomes measure: Percentage of operative delivery, primaryOutcomes measure: Indication for operative delivery, secondaryOutcomes measure: Percentage of mothers who received fetal heart rate monitoring, secondaryOutcomes measure: Indication for fetal heart rate monitoring, secondaryOutcomes measure: Apgar Score, secondaryOutcomes measure: Percentage of use of bag and mask ventilation in neonates, secondaryOutcomes measure: Percentage of neonates with neonatal encephalopathy, secondaryOutcomes measure: Percentage of neonates with neonatal encephalopathy, secondaryOutcomes measure: Percentage of neonates with hypoxemia, secondaryOutcomes measure: Percentage of infants with neonatal hypoxic-ischemic encephalopathy, secondaryOutcomes measure: Percentage of neonatal ICU admissions, secondaryOutcomes measure: Percentage of maternal rehospitalization, secondaryOutcomes measure: Percentage of neonatal rehospitalization, secondaryOutcomes measure: Infant/child developmental assessment, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Cameroon Baptist Convention Health Services, city: Douala, country: Cameroon, contacts name: Pius Tih Muffih, PhD, role: CONTACT, phone: 677764781, email: piustih@cbchealthservices.org, contacts name: Rahel Kyeng Mbah, role: CONTACT, phone: 370 371378, email: kyeng2003@yahoo.co.uk, contacts name: Akila Subramaniam, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Pius Tih Miffih, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 4.04827, lon: 9.70428, locations facility: Egerton University/Nakuru County Referral Hospital, city: Nakuru, country: Kenya, contacts name: Amos Otara, MD, role: CONTACT, phone: 254 7222 7470, email: amosotara@yahoo.com, contacts name: Elizabeth G Kibaru, MbchB, Mmed, role: CONTACT, phone: 072 942 394, email: ekibaru@egerton.ac.ke, contacts name: Nora Switchenko, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Amos Otara, MD, role: SUB_INVESTIGATOR, geoPoint lat: -0.28333, lon: 36.06667, locations facility: University Teaching Hospital, city: Lusaka, country: Zambia, contacts name: Elwyn Chomba, MD, role: CONTACT, phone: 0211 254 655, email: elwynchomba@gmail.com, contacts name: Musaku Mwenechanya, MD, role: CONTACT, phone: +260966722966, email: mmusaku@gmail.com, contacts name: Elwyn Chomba, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Musaku Mwenechanya, MD, role: SUB_INVESTIGATOR, geoPoint lat: -15.40669, lon: 28.28713, hasResults: False