曲马多、对乙酰氨基酚和安慰剂在活跃期分娩中的镇痛效果与产科影响 (TRAMPA)
曲马多、扑热息痛与安慰剂在活跃分娩中的镇痛效果及产科影响：一项随机双盲对照试验
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Ricardo A. Gutierrez-Ramirez, MD, MSc
- 电话号码：+50497546940
- 邮箱：ricardo.gutierrez@unah.edu.hn
学习地点
-
-
Francisco Morazán Department
-
Tegucigalpa、Francisco Morazán Department、洪都拉斯、11101
- 招聘中
- Hospital Escuela
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接触：
- Ricardo A. Gutierrez Ramirez, MD, MSc.
- 电话号码：50497546940
- 邮箱：ricardo.gutierrez@unah.edu.hn
-
首席研究员：
- Jessica M. Peña Ordoñez, MD
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副研究员：
- Jose A. Mendoza Rodriguez, MD
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Tegucigalpa、Francisco Morazán Department、洪都拉斯、11101
- 招聘中
- Instituto Hondureño de Seguridad Social
-
接触：
- Ricardo A. Gutierrez-Ramirez, MD, MSc.
- 电话号码：50497546940
- 邮箱：ricardo.gutierrez@unah.edu.hn
-
首席研究员：
- Ethel A. Cruz Valdivieso, MD
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副研究员：
- Raphael Amador Umanzor, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
实验性的：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). |
|
安慰剂比较：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of Active Labor
大体时间：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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of Expulsive Phase (Second Stage)
大体时间：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.
|
|
Type of Delivery
大体时间：At delivery
|
Classification of delivery outcome: spontaneous vaginal delivery, instrumental delivery (forceps or vacuum), or cesarean section. Assessed by attending obstetrician. |
At delivery
|
|
Need for Oxytocin Augmentation
大体时间：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).
|
|
Maternal Adverse Events
大体时间：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
大体时间：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.
|
|
Neonatal Complications
大体时间：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.
|
|
Pain Scores (Visual Analog Scale)
大体时间：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.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subgroup Analysis by Maternal Age
大体时间：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
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PO-UNAH-49-7-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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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