이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

활동 분만 중 트라마돌, 파라세타몰 및 위약의 진통 효과 및 산과적 효과 (TRAMPA)

2026년 11월 2일 업데이트: Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras

진통제 효능 및 산과적 효과: 트라마돌, 파라세타몰 및 위약의 활성 분만 중 비교 - 무작위 이중 맹검 대조 시험

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

300

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 온두라스
    • Francisco Morazán Department
      • Tegucigalpa, Francisco Morazán Department, 온두라스, 11101
        • 모병
        • Hospital Escuela
        • 연락하다:
        • 수석 연구원:
          • Jessica M. Peña Ordoñez, MD
        • 부수사관:
          • Jose A. Mendoza Rodriguez, MD
      • Tegucigalpa, Francisco Morazán Department, 온두라스, 11101
        • 모병
        • Instituto Hondureño de Seguridad Social
        • 연락하다:
        • 수석 연구원:
          • Ethel A. Cruz Valdivieso, MD
        • 부수사관:
          • Raphael Amador Umanzor, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

15년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
의약품: 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.
실험적: 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).
의약품: 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).
위약 비교기: 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).
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Duration of Active Labor
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Duration of Expulsive Phase (Second Stage)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
Subgroup Analysis by Maternal Age
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Universidad Nacional Autonoma de Honduras

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 15일

기본 완료 (추정된)

2026년 11월 30일

연구 완료 (추정된)

2026년 11월 30일

연구 등록 날짜

최초 제출

2026년 2월 17일

QC 기준을 충족하는 최초 제출

2026년 2월 24일

처음 게시됨 (실제)

2026년 2월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PO-UNAH-49-7-2026

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다