Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia (DIANA)
2026年5月22日 更新者：ZANFINI BRUNO ANTONIO、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia: a Machine-learning Approach. The DIANA (Dosing Intrapartum ANAesthetics) Study.
Epidural analgesia is the gold standard for controlling labour pain. However, labour pain happens during neuraxial analgesia, due to anaesthetic, obstetric, maternal factors.
The investigators hypothesized that relevant variables, able to predict the local anaesthetic (LA) requirement during labour, can be identified at admission and each parturient may therefore be accordingly classified in "low-requirement" and "high-requirement". In this way, a predictive score may be developed, and the analgesic regimen may be matched to the individual patient, thus ensuring a timely and appropriate treatment of patients likely to require higher doses of LA, while minimizing potentially side effects of excessive treatment in the low-dose group.
調査の概要
研究の種類
観察的
入学 (推定)
12500
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
- 名前：Bruno A Zanfini, MD
- 電話番号：06 3015 3105
- メール：brunoantonio.zanfini@policlinicogemelli.it
研究場所
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RM
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Rome、RM、イタリア、00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
All parturients who delivered via vaginal route or intrapartum caesarean section and received neuraxial analgesia (epidural analgesia (EA) or combined spinal-epidural [CSE] analgesia or dural puncture epidural (DPE)) in Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, between January 1st, 2020 and March 01th, 2026 (including follow-up data), meeting the inclusion criteria.
説明
Inclusion Criteria:
- Parturients receiving neuraxial analgesia for labour, as clinical practice
Exclusion Criteria:
- Planned caesarean delivery
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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All parturients between January 2020 and March 2026
All parturients who delivered via vaginal route or intrapartum caesarean section and received neuraxial analgesia (epidural analgesia (EA) or combined spinal-epidural [CSE] analgesia or dural puncture epidural (DPE)) in Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, between January 1st, 2020 and March 01th, 2026 (including follow-up data), meeting the inclusion criteria.
Labour analgesia was maintained through manual top-up boluses or PIEB (Programmed Intermittent Epidural Bolus).
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A machine-learning prediction model will be developed to anticipate the parturient's requirement of LA at admission in the Labour Suite, according to demographic, obstetric and anaesthetic features ongoing before administration of the first epidural bolus.
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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 |
|---|---|---|
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Machine-learning algorithm able to predict the LA consumption
時間枠：From the epidural catheter placement to delivery.
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To develop a machine-learning algorithm able to predict the mean hourly cumulative LA consumption administered via the epidural catheter from the catheter placement up to delivery, expressed as time-weighted LA consumption per hour (mg/h) in patients receiving top-up analgesia or the need for adjunctive rescue LA boluses in patients receiving PIEB (Programmed Intermittent Epidural Bolus) analgesia.
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From the epidural catheter placement to delivery.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical score
時間枠：At admission in the Labour Suite and before the epidural catheter is placed
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To develop a clinical score, based on the machine learning algorithm, with the aim of predicting the patient's LA requirement at admission, thus categorizing parturients as "low requirement" or "high requirement".
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At admission in the Labour Suite and before the epidural catheter is placed
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Time-dependent AUC of LA manual boluses
時間枠：From epidural catheter placement to delivery.
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To compare (between low- and high-requirement parturients) the time-dependent AUC of LA boluses (in case of analgesia maintenance through top-up) and the time-dependent AUC of adjunctive rescue LA boluses (in case of analgesia maintenance through PIEB)
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From epidural catheter placement to delivery.
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Total LA consumption
時間枠：From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD)
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From epidural catheter placement to delivery.
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Ratio of time to first bolus demand to duration of labor
時間枠：From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the ratio of time to first bolus demand to duration of labor (%), mean (+-SD), in case of analgesia maintenance through top-up.
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From epidural catheter placement to delivery.
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Total demand of LA boluses
時間枠：From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total demand of LA boluses, mean (+-SD), in case of analgesia maintenance through top-up.
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From epidural catheter placement to delivery.
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Total adjunctive rescue LA epidural boluses
時間枠：From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total adjunctive rescue LA epidural boluses, mean (+-SD), in case of analgesia maintenance through PIEB.
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From epidural catheter placement to delivery.
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Length of active phase
時間枠：From start of the active phase to full cervical dilation, up to 24 hours.
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To compare between low- and high-requirement parturients the length of active phase in minutes, mean (+-SD).
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From start of the active phase to full cervical dilation, up to 24 hours.
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Length of second stage
時間枠：From full cervical dilation to delivery.
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To compare between low- and high-requirement parturients the length of second stage in minutes, mean (+-SD).
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From full cervical dilation to delivery.
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Rate of postpartum haemorrhage
時間枠：In the first hour after delivery.
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To compare between low- and high-requirement parturients the rate of postpartum haemorrhage, expressed as percentage.
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In the first hour after delivery.
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Rate of perineal laceration
時間枠：In the first hour after delivery.
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To compare between low- and high-requirement parturients the rate of perineal laceration, expressed as percentage.
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In the first hour after delivery.
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Rate of episiotomy
時間枠：At delivery.
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To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
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At delivery.
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Rate of shoulder dystocia
時間枠：At delivery.
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To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.
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At delivery.
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Rate of intrapartum caesarean section
時間枠：From admission to the Labour suite to delivery, up to 24 hours.
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To compare between low- and high-requirement parturients the rate of intrapartum caesarean section, expressed as percentage.
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From admission to the Labour suite to delivery, up to 24 hours.
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Rate of catheter re-siting during labour
時間枠：From the placement of the first epidural catheter to delivery, up to 24 hours.
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To compare between low- and high-requirement parturients the rate of catheter re-siting during labour, expressed as percentage.
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From the placement of the first epidural catheter to delivery, up to 24 hours.
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Rate of neonatal admission in NICU
時間枠：After delivery, up to 1 hour.
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To compare between low- and high-requirement parturients the rate of neonatal admission in Neonatal Intensive Care Unit (NICU).
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After delivery, up to 1 hour.
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Mean Apgar Score at 1 minute
時間枠：1 minute after delivery.
|
To compare between low- and high-requirement parturients the neonatal Apgar score at 1 minute, expressed as mean +- DS.
The Apgar score is a 10-point evaluation scoring system used to assess a newborn's health immediately after birth, based on 5 criteria: Appearance, Pulse, Grimace, Activity, and Respiration.
Each category is assigned a score of 0, 1 or 2.
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1 minute after delivery.
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Mean Apgar Score at 5 minutes
時間枠：5 minutes after delivery.
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To compare between low- and high-requirement parturients the neonatal Apgar score at 5 minutes, expressed as mean +- DS.
The Apgar score is a 10-point evaluation scoring system used to assess a newborn's health immediately after birth, based on 5 criteria: Appearance, Pulse, Grimace, Activity, and Respiration.
Each category is assigned a score of 0, 1 or 2.
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5 minutes after delivery.
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Mean Umbilical Cord Arterial pH
時間枠：At delivery.
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To compare between low- and high-requirement parturients the umbilical cord arterial pH, expressed as mean +- DS.
Reference ranges of cord arterial pH is 7.2 - 7.4.
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At delivery.
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Mean Umbilical Cord Venous pH
時間枠：At delivery.
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To compare between low- and high-requirement parturients the umbilical cord venous pH, expressed as mean +- DS.
Reference ranges of cord venous pH is 7.25 - 7.45.
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At delivery.
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Mean Umbilical Cord Arterial base excess
時間枠：At delivery.
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To compare between low- and high-requirement parturients the umbilical cord arterial base excess, expressed as mean +- DS.
Reference ranges of cord arterial base excess is -9 to +2.
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At delivery.
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Mean Umbilical Cord Venous base excess
時間枠：At delivery.
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To compare between low- and high-requirement parturients the umbilical cord venous base excess, expressed as mean +- DS.
Reference ranges of cord venous base excess is -10 to +0.
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At delivery.
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The rate of maternal hypertensive disorders.
時間枠：Throughout pregnancy, up to the first postpartum day.
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To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders.
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Throughout pregnancy, up to the first postpartum day.
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The rate of gestational diabetes.
時間枠：Throughout pregnancy, up to delivery.
|
To compare between low- and high-requirement parturients the rate of gestational diabetes.
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Throughout pregnancy, up to delivery.
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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。
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 (推定)
2026年6月13日
一次修了 (推定)
2026年9月30日
研究の完了 (推定)
2026年10月31日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月22日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月22日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。