Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Pregnancy rates in the first month of contraceptive use
研究概览
简要总结
This project will quantify rates of contraceptive failure when unprotected intercourse occurs 6-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's and Implants).
详细描述
Women seeking emergency contraception (EC) frequently report multiple recent episodes of unprotected sex. Although high sensitivity urine pregnancy tests effectively rule-out pregnancy resulting from sex that occurred more than 14 days ago, clinicians are frequently concerned that pregnancy may result from unprotected sex that occurred <14 days prior to IUD placement. Placement of a copper IUD within 5 days of unprotected sex is a highly effective form of EC. Among 52 Chinese women who reported unprotected intercourse 5-7 days prior to copper IUD insertion, no pregnancies occurred. However, the effectiveness of the copper IUD when unprotected sex occurs 7-14 days prior to IUD placement is unknown. Intrauterine pregnancies rarely occur with a copper IUD in place. As some clinicians are concerned about injuring a pregnancy that occurs with an IUD in place, women who have had unprotected sex 7-14 days prior to requesting IUD placement are typically told they must use another, less effective, contraceptive for 2+ weeks and then return to obtain an IUD. To remove this barrier to emergency placement of a copper IUD, we propose to study rates of pregnancy when a copper IUD is placed "any time a urine pregnancy test is negative." We believe that simplifying guidance regarding the recommended timing of copper IUD placement has the potential to significantly increase the number of women offered "same-day" IUD service.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 45 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 15 and 45 years who request injectable, subdermal, or intrauterine contraception, 6-14 days after having unprotected intercourse.
排除标准
- •History of tubal ligation or hysterectomy.
- •Positive urine pregnancy test
研究组 & 干预措施
unprotected intercourse 6-14 days prior to contraception
Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.
干预措施: Copper T-380 IUD (Drug)
unprotected intercourse 6-14 days prior to contraception
Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.
干预措施: LNG IUD (Drug)
unprotected intercourse 6-14 days prior to contraception
Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.
干预措施: Contraceptive implant Nexplanon (Device)
unprotected intercourse 6-14 days prior to contraception
Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.
干预措施: Depo-Provera (Drug)
结局指标
主要结局
Pregnancy rates in the first month of contraceptive use
时间窗: 4 weeks from contraception initiation
This study is designed to provide clinicians and their patients with information regarding rates of contraceptive failure (i.e. undesired pregnancy) when contraception is initiated or placed for a woman who has a negative pregnancy test, but reports having had unprotected intercourse 6-14 days prior to requesting contraception.
次要结局
未报告次要终点
