A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
研究概览
简要总结
The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.
详细描述
This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.
Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone.
- •Patients selecting the IUD need to identify themselves as desiring long-term contraception.
排除标准
- •Current pregnancy,
- •Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days,
- •Current behavior suggesting a high risk for pelvic inflammatory disease
- •Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B)
- •Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that distort the uterine cavity,
- •Mucopurulent cervicitis,
- •A previously placed IUD that has not been removed
- •Genital bleeding of unknown etiology
- •Ovarian, cervical or endometrial cancer,
- •Small uterine cavity
研究组 & 干预措施
1
IUD
干预措施: Copper T380 IUD (Drug)
2
Oral levonorgestrel
干预措施: levonorgestrel (Drug)
结局指标
主要结局
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
时间窗: 6 months
Use of a method of contraception with a typical efficacy rate \>= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.
次要结局
- Pregnancy(6 months)
- Infection(6 months)
- IUD Expulsion, Removal, or Perforation(6 months)