ChiCTR-IOR-14005702CompletedNot Applicable
哺乳期放置三种宫内节育器的多中心随机对照研究
国家科学技术部26 sites in 1 country3,682 target enrollmentStarted: December 1, 2006Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,682
- Locations
- 26
- Primary Endpoint
- 妊娠率
Study Overview
Brief Summary
观察 3 种宫内节育器（IUD）的临床使用效果，探讨其使用现状的原因。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •(1)20～45 岁健康哺乳期妇女；(2)月经正常（月经周期 21～42 天且规律，经期 7 天内），无不规则阴道出血，无葡萄胎史；(3)宫腔 5.5cm～9.0cm（剖宫产术后除外）；(4)血红蛋白 90g/L 以上；(5)性生活正常，愿将 IUD 作为惟一的避孕方法,了解并自愿参加本项研究，并能按要求接收随访。
Exclusion Criteria
- •(1)妊娠或可疑妊娠；（2）明显的生殖器官畸形；（3）生殖系统或盆腔感染；（4）宫腔长度大于 9.0cm；(5）生殖器官肿瘤；（6）贫血。
Arms & Interventions
1
元宫铜 300
2
TCu380A
3
活性 165
Outcomes
Primary Outcomes
妊娠率
脱落率
医疗原因取出
脱落相关终止
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (26)
Loading locations...
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