Analgetická účinnost a porodnické účinky tramadolu, paracetamolu a placeba během aktivní porodní činnosti (TRAMPA)
Analgetická účinnost a porodnické účinky tramadolu, paracetamolu a placeba během aktivní porodní doby: Randomizovaná dvojitě zaslepená kontrolovaná studie
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Ricardo A. Gutierrez-Ramirez, MD, MSc
- Telefonní číslo: +50497546940
- E-mail: ricardo.gutierrez@unah.edu.hn
Studijní místa
-
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Francisco Morazán Department
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Tegucigalpa, Francisco Morazán Department, Honduras, 11101
- Nábor
- Hospital Escuela
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Kontakt:
- Ricardo A. Gutierrez Ramirez, MD, MSc.
- Telefonní číslo: 50497546940
- E-mail: ricardo.gutierrez@unah.edu.hn
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Vrchní vyšetřovatel:
- Jessica M. Peña Ordoñez, MD
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Dílčí vyšetřovatel:
- Jose A. Mendoza Rodriguez, MD
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Tegucigalpa, Francisco Morazán Department, Honduras, 11101
- Nábor
- Instituto Hondureño de Seguridad Social
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Kontakt:
- Ricardo A. Gutierrez-Ramirez, MD, MSc.
- Telefonní číslo: 50497546940
- E-mail: ricardo.gutierrez@unah.edu.hn
-
Vrchní vyšetřovatel:
- Ethel A. Cruz Valdivieso, MD
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Dílčí vyšetřovatel:
- Raphael Amador Umanzor, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
Experimentální: 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). |
|
Komparátor placeba: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Duration of Active Labor
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Duration of Expulsive Phase (Second Stage)
Časové okno: 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
Časové okno: At delivery
|
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
Časové okno: 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
Časové okno: 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.
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Neonatal Apgar Score at 5 Minutes
Časové okno: 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
Časové okno: From birth up to 48 hours, through hospital discharge.
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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)
Časové okno: 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.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Subgroup Analysis by Maternal Age
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Porodní bolest
- Organické chemikálie
- Farmaceutické přípravky
- Lipidy
- Anilides
- Amidy
- Anilinové sloučeniny
- Aminy
- Acetanilidy
- Krystaloidní roztoky
- Izotonická řešení
- Řešení
- Alkoholy
- Cyklohexanoly
- Hexanoly
- Mastné alkoholy
- Dimethylaminy
- Methylaminy
- Acetaminofen
- Tramadol
- Solný roztok
Další identifikační čísla studie
- PO-UNAH-49-7-2026
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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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