[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626779":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":83,"collaborators":31,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":31,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Universidad Nacional Autonoma de Honduras","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Tramadol Group","EXPERIMENTAL","Participants receive a single dose of tramadol 100 mg intravenously at the onset of active labor (cervical dilation ≥4 cm with regular contractions).",[13],"Drug: Tramadol Hydrochloride",{"label":15,"type":10,"description":16,"interventionNames":17},"Paracetamol Group","Participants receive a single dose of paracetamol 1 g intravenously (slow infusion) at the onset of active labor (cervical dilation ≥4 cm with regular contractions).",[18],"Drug: Paracetamol (acetaminophen)",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Group","PLACEBO_COMPARATOR","Participants receive a single dose of 10 mL 0.9% saline solution intravenously at the onset of active labor (cervical dilation ≥4 cm with regular contractions).",[24],"Drug: Placebo (Saline Solution)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Tramadol Hydrochloride","Tramadol 100 mg administered as a single intravenous dose at the onset of active labor. Tramadol is an atypical opioid analgesic with serotonin and noradrenaline reuptake inhibition properties. The dose is within standard clinical ranges for obstetric analgesia. Administration is performed by trained medical personnel following institutional protocols. Participants are monitored for adverse effects including nausea, vomiting, somnolence, dizziness, and hypotension.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Paracetamol (acetaminophen)","Paracetamol 1 g administered as a single intravenous slow infusion at the onset of active labor. Paracetamol is a central analgesic acting through COX-3 inhibition in the central nervous system. It is widely used during pregnancy and labor due to its favorable safety profile. Administration is performed by trained medical personnel following institutional protocols. Participants are monitored for adverse effects including nausea, vomiting, and allergic reactions (rare).",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Placebo (Saline Solution)","Placebo consisting of 10 mL 0.9% saline solution administered as a single intravenous dose at the onset of active labor. The appearance and administration procedure are identical to the active interventions to maintain blinding. No pharmacological active ingredients are present. Administration is performed by trained medical personnel following institutional protocols.",[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Ricardo A. Gutierrez-Ramirez, MD, MSc","CONTACT","+50497546940","ricardo.gutierrez@unah.edu.hn",[47,71],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hospital Escuela","RECRUITING","Tegucigalpa","Francisco Morazán Department","11101","Honduras","HN",{"type":56,"coordinates":57},"Point",[58,59],-87.20681,14.0818,{"lat":59,"lon":58},[62,65,68],{"name":63,"role":43,"phone":64,"phoneExt":31,"email":45},"Ricardo A. Gutierrez Ramirez, MD, MSc.","50497546940",{"name":66,"role":67,"phone":31,"phoneExt":31,"email":31},"Jessica M. Peña Ordoñez, MD","PRINCIPAL_INVESTIGATOR",{"name":69,"role":70,"phone":31,"phoneExt":31,"email":31},"Jose A. Mendoza Rodriguez, MD","SUB_INVESTIGATOR",{"facility":72,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Instituto Hondureño de Seguridad Social",{"type":56,"coordinates":74},[58,59],{"lat":59,"lon":58},[77,79,81],{"name":78,"role":43,"phone":64,"phoneExt":31,"email":45},"Ricardo A. Gutierrez-Ramirez, MD, MSc.",{"name":80,"role":67,"phone":31,"phoneExt":31,"email":31},"Ethel A. Cruz Valdivieso, MD",{"name":82,"role":70,"phone":31,"phoneExt":31,"email":31},"Raphael Amador Umanzor, MD",{"type":67,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Ricardo A Gutierrez Ramirez, MD, MSc, FACOG","Research Coordinator","100626779","phase-4-analgesic-efficacy-and-obstetric-effects-of-tramadol-paracetamol-and-placebo-in-active-labor-100626779",false,"NCT07440069","Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor","Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor: A Randomized Double-Blind Controlled Trial","TRAMPA","Inclusion Criteria:\n\n* Nulliparous pregnant women\n* Age between 15 and 45 years\n* Singleton pregnancy, term (37-41 weeks gestation)\n* Cephalic presentation\n* Active labor defined as cervical dilation ≥4 cm with regular contractions\n* Signed informed consent\n\nExclusion Criteria:\n\n* Multiple gestation or high-risk pregnancy (preeclampsia, gestational diabetes, etc.)\n* Known allergy or contraindication to tramadol or paracetamol\n* Recent use (less than 6 hours) of any analgesic medication\n* Previous cesarean section or other uterine surgery\n* Active infection or fever at admission\n* Inability to provide informed consent due to mental or communication conditions\n* Non-cephalic presentation\n* Rupture of membranes \\>18 hours without labor\n* Participation in another clinical trial within the last 3 months",true,"FEMALE","15 Years","45 Years",{"count":99,"type":100},300,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","This randomized, double-blind, placebo-controlled trial aims to compare the analgesic efficacy and obstetric effects of tramadol (100 mg IV) versus paracetamol (1 g IV) versus placebo (saline solution) in nulliparous women during active labor. The primary outcome is duration of active labor (minutes). Secondary outcomes include duration of expulsive phase, type of delivery, need for oxytocin augmentation, maternal adverse events (nausea, vomiting, somnolence, hypotension), and neonatal outcomes (Apgar scores at 1 and 5 minutes, NICU admission). The study hypothesizes that tramadol significantly reduces active labor duration compared to paracetamol and placebo, without compromising maternal or neonatal safety. A total of 300 nulliparous women (100 per group) will be enrolled at Hospital Escuela, Tegucigalpa, Honduras.",[106],"Labor Pain",[108,109,110,106,111],"Tramadol","Paracetamol","Acetaminophen","Labor Duration","2026-02-24",{"date":114,"type":115},"2026-02-27","ACTUAL",{"date":117,"type":100},"2026-02-15",{"date":119,"type":100},"2026-09-30",{"name":5,"class":6},2]