NCT00562276已完成4 期
Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 578
- 试验地点
- 3
- 主要终点
- IUD expulsion
研究概览
简要总结
The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate how satisfied women are with the timing of their IUD placement. Subjects will be able to choose between the Paraguard IUD or the Mirena IUD.
The researchers hypothesize that:
- the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion,
- satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and
- overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Requesting suction aspiration for spontaneous or elective abortion
- •Intrauterine pregnancy documented with ultrasound. For women with a gestational sac, the gestational age (EGA) must be ≥ 5 weeks 0 days but ≤ 12 weeks 0 days based on the following criteria:
- •If no embryonic pole present: EGA (days) = mean sac diameter (mm) + 30 (Mean sac diameter =[length+width+depth]/3)
- •If embryonic pole is present: EGA (days) determined by Hadlock scale for measured crown-rump length
- •Desiring intrauterine contraception
- •In general good health
- •Willing and able to undergo informed consent
- •Willing to comply with randomization and study follow-up schedule
排除标准
- •Pelvic exam with evidence of active cervicitis or PID (eg. purulent discharge, adnexal mass, significant cervical or uterine tenderness)
- •PID or sexually transmitted infection within the previous three months
- •History of pelvic Actinomyces
- •Unexplained vaginal bleeding
- •Uterine anomaly (eg. bicornuate uterus)
- •Leiomyomata that distort the uterine cavity
- •Known or suspected complete molar pregnancy
- •Current confirmed or possible ectopic pregnancy
- •AIDS without treatment (individuals with HIV/AIDS who are clinically well are not excluded)
- •Any prior surgical aspiration during this current pregnancy
- •Use of osmotic dilators (eg. laminaria) or misoprostol for cervical preparation during the aspiration procedure
- •Allergy to polyethylene
- •Allergy to levonorgestrel (for levonorgestrel-containing IUS only)
- •Allergy to copper (for copper T380A IUD only)
- •Wilson's disease (for copper T380A IUD only)
- •Current participation in another research study which would interfere with the conduct of this study
研究组 & 干预措施
1
Experimental
Immediate IUD insertion following suction aspiration between 5 and 12 weeks gestation
干预措施: Immediate IUD insertion (Procedure)
2
No Intervention
Delayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation
结局指标
主要结局
IUD expulsion
时间窗: 1, 3 and 6 months after insertion
次要结局
- IUD continuation(1, 3 and 6 months after insertion)
研究者
Paula Bednarek
Assistant Professor SM.OB/GYN Generalist Division
Oregon Health and Science University
研究点 (3)
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