the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the duration of menstrual bleeding.
研究概览
简要总结
investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.
详细描述
This study will be randomized controlled trial will be performed at the Obstetric and Gynecological Department at Beni-Suef University Hospital, Faculty of Medicine Target Population: All females with first time use of IUD inserted at the Obstetrics and Gynecology department through 3 months from the start of July 2023 till the end of November 2023.
Participants will be assigned in a 1:1 ratio to the use of vitamin B 1 or placebo, in accordance with a random table produced by an Excel program, with A being assigned to the intervention group and B to the control group. All women will sign a written informed consent prior to data collection.
Each woman within the intervention group will receive a packet containing 30 pills (vitamin B 1 or placebo), each month for three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with first time use of the IUD
- •a history of normal menstrual bleeding with duration of 3 to 7 days without spotting, a menstrual cycle lasting 23 to 35 days,
- •use of 10 to 14 sanitary pads per cycle before IUD insertion
- •gravidity ranging between 1 and 4.
排除标准
- •Patients with cardiac, hepatic or renal diseases.
- •Patients with bleeding disorders.
- •Patients with systemic diseases.
研究组 & 干预措施
Vitamin B 1
VITAMIN B1 (High Potency) 500mg
干预措施: VITAMIN B1 500mg (Drug)
Vitamin B 1
VITAMIN B1 (High Potency) 500mg
干预措施: intra-uterine contraceptive device (Device)
control
patient not subjected to treatment . only follow up
干预措施: intra-uterine contraceptive device (Device)
结局指标
主要结局
the duration of menstrual bleeding.
时间窗: 3 cycles ( 3 months / one month for each cycle)
days of menstruation
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University