Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes
Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes: A Retrospective Cohort Study Using a Single-Center Delivery Database
The goal of this retrospective observational cohort study is to explore the associations between neuraxial labor analgesia and maternal-neonatal infectious outcomes among women attempting vaginal delivery, and to distinguish genuine infectious risks from clinical fever-related diagnostic and treatment pathways. The main question it aims to answer is:
Does neuraxial labor analgesia increase the risk of composite neonatal infectious outcomes in singleton live birth women attempting vaginal delivery? Participants who met inclusion criteria with clear neuraxial labor analgesia exposure status (exposed group receiving neuraxial labor analgesia during labor; unexposed group without such analgesia) were extracted from the hospital's delivery database covering 2015 to 2022, and their pre-delivery baseline characteristics, labor course records, maternal fever, intrapartum antibiotic administration, clinical chorioamnionitis diagnosis and neonatal infectious diagnosis data were retrospectively analyzed via multiple statistical adjustment approaches including propensity score weighting, sensitivity analysis and negative control analysis.
調査の概要
状態
研究の種類
入学 (推定)
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Delivery year ranging from 2015 to 2022;
- Singleton pregnancy with live birth;
- Records of labor induction or spontaneous uterine contraction documented in the database, consistent with the definition of planned or attempted vaginal delivery;
- Clear documentation of exposure status to labor analgesia;
- Availability of key baseline covariates including maternal age and gestational age.
Exclusion Criteria:
- Multiple pregnancy, fetal death or stillbirth;
- Missing data on labor analgesia exposure;
- Unavailable key baseline data, precluding inclusion in the primary adjusted model;
- Missing database entries for spontaneous uterine contraction or labor induction; such cases were excluded from the primary target cohort, as they were more likely to represent elective cesarean delivery or unplanned vaginal delivery.
研究計画
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 |
|---|---|
|
exposed group
Mothers and their neonates who received neuraxial labor analgesia
|
The studied intervention, neuraxial labor analgesia, is defined as epidural or combined spinal-epidural pain relief delivered by spinal canal puncture during active vaginal labor.
|
|
unexposed group
Mothers and their neonates who didn't receive neuraxial labor analgesia
|
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 |
|---|---|---|
|
Composite outcome of neonatal infection
時間枠：From birth until neonatal hospital discharge, assessed up to 90 days after birth
|
Neonatal sepsis, pneumonia, necrotizing enterocolitis (NEC), or unspecified site infection documented during postnatal hospitalization.
|
From birth until neonatal hospital discharge, assessed up to 90 days after birth
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026R0399
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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