The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart
研究概览
简要总结
Research hypothesis: Release of levonorgestrel from Metraplant-E levonorgestrel releasing intrauterine contraceptive device is inadequate to be used as a medical line of treatment of dysfunctional uterine bleeding.
The investigators aim to evaluate the therapeutic effect of the intrauterine system (Metraplant-E) in the treatment of dysfunctional uterine bleeding.
详细描述
Primary outcome : The investigators aim to evaluate the short term release of levonorgestrel from the Metraplant-E levonorgestrel releasing intrauterine contraceptive devices (IUCDs). This is in a trial to determine to what extent the intrauterine release of levonorgestrel would reduce MBL in women with menorrhagia and if the treatment would increase the body iron stores and the degree of patient satisfaction and acceptability of treatment for the patients with dysfunctional uterine bleeding. This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale.
Secondary outcome:
-
Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E).
-
Haemoglobin level measurement in gm/dl and serum ferritin level on same occasions as when endometrial biopsy is done.
-
The amount of monthly menstrual blood loss after the insertion the Metraplant-E levonorgestrel releasing intrauterine contraceptive devices using the following scores: bleeding index,total bleeding score and Pictorial blood loss assessment chart (PBAC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women seeking contraception.
- •Women with history of menorrhagia.
- •Pre and perimenopausal women who are married or previously married.
- •Failure of other medical treatment to control menorrhagia such as hemostatics.
- •Women who did not tolerate copper IUD due to increased amount of menstrual blood loss which could lead to anemia.
排除标准
- •History of ectopic pregnancy .
- •Pregnancy or suspicion of pregnancy.
- •Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity.
- •Acute pelvic inflammatory disease
- •Postpartum endometritis or infected abortion in the past 3 months.
- •Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear.
- •Genital bleeding of unknown etiology.
- •Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections, until infection is controlled.
- •Acute liver disease or liver tumor (benign or malignant).
- •Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, leukemia, acquired immune deficiency syndrome (AIDS), and I.V. drug abuse.
- •A previously inserted IUD that has not been removed.
- •Hypersensitivity to any component of this product.
- •Women taking anticoagulants
- •Women with coagulopathies due to thrombocytopenia or platelets dysfunction.
- •Known or suspected carcinoma of the breast.
结局指标
主要结局
Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart
时间窗: 6 months
This is in a trial to determine to what extent the intrauterine release of levonorgestrel would reduce menstrual blood loss (MBL) in women with menorrhagia and if the treatment would increase the body iron stores and the degree of patient satisfaction and acceptability of treatment for the patients with dysfunctional uterine bleeding. This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale.
次要结局
- Hemoglobin level in blood prior to the device insertion and 6 months afterwards(6 months)
- Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E)(6 months)
研究者
Alshaimaa Ahmad Aboulfetouh Mahmoud
Obgyn resident
Ain Shams Maternity Hospital