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トラマドール、パラセタモール、プラセボの陣痛時の鎮痛効果と産科的影響 (TRAMPA)

2026年11月2日 更新者：Ricardo A Gutierrez Ramirez, MD, MSc, FACOG、Universidad Nacional Autonoma de Honduras

トラマドール、パラセタモール、プラセボの分娩進行期における鎮痛効果と産科的影響：無作為化二重盲検比較試験

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

300

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ホンジュラス
    • Francisco Morazán Department
      • Tegucigalpa、Francisco Morazán Department、ホンジュラス、11101
        • 募集
        • Hospital Escuela
        • コンタクト：
        • 主任研究者：
          • Jessica M. Peña Ordoñez, MD
        • 副調査官：
          • Jose A. Mendoza Rodriguez, MD
      • Tegucigalpa、Francisco Morazán Department、ホンジュラス、11101
        • 募集
        • Instituto Hondureño de Seguridad Social
        • コンタクト：
        • 主任研究者：
          • Ethel A. Cruz Valdivieso, MD
        • 副調査官：
          • Raphael Amador Umanzor, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

15年～45年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
薬：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.
実験的：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).
薬：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).
プラセボコンパレーター：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).
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Duration of Active Labor
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Duration of Expulsive Phase (Second Stage)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Subgroup Analysis by Maternal Age
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Universidad Nacional Autonoma de Honduras

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年2月15日

一次修了 (推定)

2026年11月30日

研究の完了 (推定)

2026年11月30日

試験登録日

最初に提出

2026年2月17日

QC基準を満たした最初の提出物

2026年2月24日

最初の投稿 (実際)

2026年2月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PO-UNAH-49-7-2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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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