Eficácia Analgésica e Efeitos Obstétricos de Tramadol, Paracetamol e Placebo no Trabalho de Parto Ativo (TRAMPA)
Eficácia Analgésica e Efeitos Obstétricos de Tramadol, Paracetamol e Placebo no Trabalho de Parto Ativo: Um Ensaio Controlado Randomizado Duplo-Cego
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
This is a randomized, double-blind, parallel-group, superiority efficacy trial comparing three interventions: tramadol 100 mg IV, paracetamol 1 g IV, and placebo (10 mL 0.9% saline solution) administered at the onset of active labor (cervical dilation ≥4 cm with regular contractions). The study design follows CONSORT guidelines for randomized controlled trials. Randomization will be performed using REDCap's automated randomization module in variable block sizes, ensuring allocation concealment. Double-blinding is maintained: participants, care providers, and outcome assessors are masked to group assignment. The primary endpoint is duration of active labor (minutes from intervention administration to complete cervical dilation). Secondary endpoints include: duration of expulsive phase (minutes), type of delivery (spontaneous vaginal, instrumental, cesarean), need for oxytocin augmentation, maternal adverse events (nausea, vomiting, somnolence, hypotension, pruritus, dizziness), neonatal Apgar scores at 1 and 5 minutes, birth weight, meconium-stained amniotic fluid, NICU admission, and neonatal asphyxia. Data collection includes sociodemographic variables (age, education, marital status, occupation), obstetric variables (gestational age, prenatal care visits, BMI, membrane status, cervical dilation at intervention, baseline fetal heart rate), and pain scores (Visual Analog Scale pre-intervention, 30 min, 1h, 2h post-intervention). Statistical analysis includes ANOVA or Kruskal-Wallis for continuous variables, chi-square for categorical variables, and logistic regression for binary outcomes, with significance set at p<0.05. A Data Safety Monitoring Board will oversee safety every 3 months. The study is funded by Universidad Nacional Autónoma de Honduras and will be conducted at Hospital Escuela, Tegucigalpa, from Feb. 2026 to June 2026.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Ricardo A. Gutierrez-Ramirez, MD, MSc
- Número de telefone: +50497546940
- E-mail: ricardo.gutierrez@unah.edu.hn
Locais de estudo
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Francisco Morazán Department
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Tegucigalpa, Francisco Morazán Department, Honduras, 11101
- Recrutamento
- Hospital Escuela
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Contato:
- Ricardo A. Gutierrez Ramirez, MD, MSc.
- Número de telefone: 50497546940
- E-mail: ricardo.gutierrez@unah.edu.hn
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Investigador principal:
- Jessica M. Peña Ordoñez, MD
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Subinvestigador:
- Jose A. Mendoza Rodriguez, MD
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Tegucigalpa, Francisco Morazán Department, Honduras, 11101
- Recrutamento
- Instituto Hondureño de Seguridad Social
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Contato:
- Ricardo A. Gutierrez-Ramirez, MD, MSc.
- Número de telefone: 50497546940
- E-mail: ricardo.gutierrez@unah.edu.hn
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Investigador principal:
- Ethel A. Cruz Valdivieso, MD
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Subinvestigador:
- Raphael Amador Umanzor, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Nulliparous pregnant women
- Age between 15 and 45 years
- Singleton pregnancy, term (37-41 weeks gestation)
- Cephalic presentation
- Active labor defined as cervical dilation ≥4 cm with regular contractions
- Signed informed consent
Exclusion Criteria:
- Multiple gestation or high-risk pregnancy (preeclampsia, gestational diabetes, etc.)
- Known allergy or contraindication to tramadol or paracetamol
- Recent use (less than 6 hours) of any analgesic medication
- Previous cesarean section or other uterine surgery
- Active infection or fever at admission
- Inability to provide informed consent due to mental or communication conditions
- Non-cephalic presentation
- Rupture of membranes >18 hours without labor
- Participation in another clinical trial within the last 3 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tramadol Group
Participants receive a single dose of tramadol 100 mg intravenously at the onset of active labor (cervical dilation ≥4 cm with regular contractions). |
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. |
|
Experimental: 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). |
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). |
|
Comparador de Placebo: Placebo Group
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). |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of Active Labor
Prazo: From intervention administration (at active labor onset) up to 12 hours.
|
Time in minutes from administration of study intervention (at onset of active labor defined as cervical dilation ≥4 cm with regular contractions) to complete cervical dilation (10 cm) or delivery, whichever occurs first. Measured and recorded by attending obstetric staff using standardized timing protocols. |
From intervention administration (at active labor onset) up to 12 hours.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of Expulsive Phase (Second Stage)
Prazo: During delivery, from complete cervical dilation up to 120 minutes.
|
Time in minutes from complete cervical dilation (10 cm) to fetal expulsion. Measured and recorded by attending obstetric staff. |
During delivery, from complete cervical dilation up to 120 minutes.
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Type of Delivery
Prazo: At delivery
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Classification of delivery outcome: spontaneous vaginal delivery, instrumental delivery (forceps or vacuum), or cesarean section. Assessed by attending obstetrician. |
At delivery
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Need for Oxytocin Augmentation
Prazo: During labor (from intervention administration up to 24 hours).
|
Requirement for additional oxytocin administration to augment uterine contractions during labor. Recorded as yes/no, including dose and timing if applicable. |
During labor (from intervention administration up to 24 hours).
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Maternal Adverse Events
Prazo: From intervention administration up to 24 hours postpartum.
|
Occurrence of any adverse events potentially related to the intervention, including: nausea, vomiting, somnolence, dizziness, headache, pruritus, hypotension (systolic BP <90 mmHg), or allergic reactions. Severity graded as mild, moderate, or severe. |
From intervention administration up to 24 hours postpartum.
|
|
Neonatal Apgar Score at 5 Minutes
Prazo: At 5 minutes after birth.
|
Apgar score assessed at 5 minutes after birth. Score ranges from 0-10, with higher scores indicating better neonatal condition. |
At 5 minutes after birth.
|
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Neonatal Complications
Prazo: From birth up to 48 hours, through hospital discharge.
|
Occurrence of neonatal complications including: Apgar score <7 at 5 minutes, meconium-stained amniotic fluid, need for neonatal resuscitation, NICU admission, or neonatal asphyxia |
From birth up to 48 hours, through hospital discharge.
|
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Pain Scores (Visual Analog Scale)
Prazo: Pre-intervention, and at 30 minutes, 1 hour, and 2 hours post-intervention.
|
Maternal pain assessed using Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain). Measured at baseline (pre-intervention), 30 minutes, 1 hour, and 2 hours post-intervention. |
Pre-intervention, and at 30 minutes, 1 hour, and 2 hours post-intervention.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Subgroup Analysis by Maternal Age
Prazo: Throughout study period, average of six months
|
Comparison of primary and secondary outcomes stratified by maternal age categories (<20 years, 20-35 years, >35 years). |
Throughout study period, average of six months
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor de parto
- Produtos químicos orgânicos
- Preparações farmacêuticas
- Lipídios
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Acetanilidas
- Soluções cristalóides
- Soluções isotônicas
- Soluções
- Álcoons
- Ciclohexanóis
- Hexanóis
- Álcoois gordurosos
- Dimetilaminas
- Metilaminas
- Paracetamol
- Tramadol
- Solução salina
Outros números de identificação do estudo
- PO-UNAH-49-7-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data (anonymized) will be shared for scientific purposes related to obstetric analgesia and labor management. Only de-identified datasets will be shared with qualified researchers upon reasonable request and with appropriate ethics committee approval. Participants will be informed of data sharing plans during the informed consent process and may opt out.
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