Effect of levonorgestrel releasing intrauterine system on heavy menstrual bleeding and uterine artery doppler indices A prospective quasi experimental study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pictorial blood assessment chart PBAC score and Hemoglobin
研究概览
简要总结
This is a prospective quasi experimental pre post intervention study conducted in the
Department of Obstetrics and Gynaecology at J R Medical College and Hospital Tindivanam.
After obtaining approval from the Institutional Ethics Committee and written informed consent
from participants eligible women aged 30–45 years with heavy menstrual bleeding will
be recruited from the gynecology outpatient department. Baseline data including detailed
menstrual history PBAC scoring physical and pelvic examination and relevant investigations
will be collected. A Pap smear and endometrial biopsy will be performed to
rule out malignancy. Transvaginal sonography will be carried out to assess endometrial
thickness and uterine artery Doppler indices the resistance index and pulsatility index
in the arcuate and radial arteries. Color Doppler ultrasound was used to pinpoint the arcuate artery
in the outer myometrial layer and radial arteries extending into the endometrium. A pulsed wave
Doppler, set at a 2 mm sampling size and an insonation angle under 30 degrees. The mean Pulsatility
Index and Resistance Index were automatically calculated from at least three consistent
waveforms. Following the baseline assessment all participants will undergo insertion of a
levonorgestrel releasing intrauterine system 52 mg releasing 20 mcg per day using asterile no touch technique in the OPD. Participants will be advised to maintain a menstrual diary
to track PBAC scores throughout the study period. Follow-up visits will be conducted at 3
months and 6 months post insertion. At each follow up PBAC scores and hemoglobin levels
will be recorded and repeat TVS with Doppler will be performed to reassess endometrial
thickness and uterine artery flow indices. Data will be analyzed to assess changes in primary
outcomes the PBAC score and hemoglobin levels and secondary outcomes (endometrial
thickness and Doppler indices at 3 and 6 months compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Clinical diagnosis of heavy menstrual bleeding Uterine size less than 14 weeks Multiparous women Failed oral medications Willing to give informed consent.
排除标准
- •Congenital or acquired uterine anomalies Submucous fibroid distorting the uterine cavity Uterine size more than 14 weeks Acute pelvic inflammatory disease Malignancy or suspected endometrial cancer.
结局指标
主要结局
Pictorial blood assessment chart PBAC score and Hemoglobin
时间窗: At insertion and 3 months and 6 months post insertion of levonorgestrel intrauterine system
次要结局
- Endometrial thickness(At insertion and 3months and 6 months post insertion of levonorgestrel intrauterine system)
- Resistance index and pulsatility index of arcuate and radial arteries(At insertion and 3 months and 6 months post insertion of levonorgestrel intrauterine system)
研究者
Dr Monisha S
JR Medical College and Hospital