ChiCTR2200063049Not yet recruitingEarly Phase 1
山莨菪碱在 LO-PE 患者围术期应用对胎儿血氧分压及 apgar 评分的影响
个人1 site in 1 country120 target enrollmentStarted: August 15, 2022Last updated:
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 胎儿血氧分压
Study Overview
Brief Summary
本研究拟通过观察新生儿血氧分压及 apgar 评分等指标变化，以评价山莨菪碱在晚发型子痫前期应用的有效意义，为临床诊疗中合并有晚发型子痫前期产妇的围术期麻醉前用药及管理提供参考。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- 双盲法
Eligibility Criteria
- Ages
- 21 to 45 (—)
- Sex
- Female
Inclusion Criteria
- •符合《妇产科学（第七版）》诊断标准首次确诊为妊娠期高血压疾病中晚发型子痫前期产妇；
- •ASA II-III 级、单胎、无椎管内麻醉禁忌。
Exclusion Criteria
- •合并其他妊娠期并发症者；
- •合并有严重的心、脑、肾等重要脏器器质性疾病；
- •有颅内压增高、青光眼、幽门梗阻等禁忌症；
Arms & Interventions
实验组
静脉给予山莨菪碱
对照组
静脉给予生理盐水
Outcomes
Primary Outcomes
胎儿血氧分压
Time Frame: 胎儿取出后断脐
apgar 评分
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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