CTRI/2022/09/045810招募中4 期
Single arm, Open label, Multicentre, Prospective Observational study to evaluate safety and performance of Intrauterine Contraceptive Device
PREGNA INTERNATIONAL LTD0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Adult female of any reproductive age (21-45 years of age)
- •Women who require contraception
- •Women at high risk of pregnancy
排除标准
- •Subjects with malignant diseases of the genital tract
- •Subjects with undiagnosed vaginal bleeding - Subjects who are pregnant
- •Subjects with past history of ectopic pregnancy or predisposing factors.
- •Subjects with infections of the genital tract
- •Subjects with sexually transmitted diseases during the last 12 months (except bacterial vaginitis, repeated herpes infection, Hepatitis B)
- •Subjects with abortion with infection during the last 3 months, pelvic inflammatory disease
- •Subjects with uterine malformations (congenital or acquired)
- •Subjects with allergy to copper
- •Subjects with Anemia
- •Subjects with valvular heart disease
- •Subjects with coagulation disorders
- •Subjects with anti-inflammatory treatment - Subjects with Wilsonâ??s disease
- •Subjects with multiple exposures to different sexual partners
- •Subject not willing for IUD insertion.
研究者
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