Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- menstrual changes.
研究概览
简要总结
To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual changes after 3 months of insertion of copper T-380 IUD and LNG-IUS
详细描述
A randomized prospective clinical trial
Study Population:
The study population includes multiparous women, having normal menstrual cycles, who are eligible for insertion of IUCD. Women will be recruited for enrollment when they come to the family planning clinic. They will be counseled about different contraceptive options. If they want to have the IUCD, they will be asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria Women will be enrolled in the study after giving written informed consent Group (A): ....Women will have the copper T-380 IUD (PREGNA, India, imported by DKT Egypt LLC-Egypt) ® IUD.
Group (B): .... Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Desire to have intrauterine contraceptive device after counseling about different contraceptive options and consented to the study.
- •Normal menstrual bleeding cycles (24-35 days).
排除标准
- •Nulliparity.
- •Undiagnosed uterine bleeding.
- •Any proven ovarian, uterine or endometrial pathology such as; uterine myoma, adenomyosis, endometrial polyps, ovarian cysts
- •Contraceptive pills had not been taken during the previous 3 months and any previous IUD had been removed at least 1 month earlier
- •Hemorrhagic disorders.
- •Acute or chronic pelvic inflammatory disease
- •Known uterine anomalies e.g., Bicornuate/septate Uterus.
- •Anemia (hemoglobin <10 g/dl).
- •Diagnosis of active cervical infection
- •Dysplasia in the cervix.
- •Patients wishing post-partum or post-abortum IUD insertion
结局指标
主要结局
menstrual changes.
时间窗: 3 months after insertion
Pictorial blood loss assessment chart PBAC score (a score \>100was equivalent to blood loss \>80 mL)
uterine artery pulsatility index
时间窗: 3 months after insertion
trans-vaginal ultrasound pulsed doppler
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University