the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.

Study Overview
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Brief Summary
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investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.

Detailed Description
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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.

Official Title
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the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.

Conditions
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Intra-uterine Device Complication

Intervention / Treatment
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* Drug: VITAMIN B1 500mg
* Device: intra-uterine contraceptive device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with cardiac, hepatic or renal diseases. Patients with bleeding disorders. Patients with systemic diseases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin B 1<br>VITAMIN B1 (High Potency) 500mg | Drug: VITAMIN B1 500mg<br>* VITAMIN B1 (High Potency) 500mg tab every day for 3 months<br>* Other names: VITAMIN B1 500mg @Biovea;Device: intra-uterine contraceptive device<br>* intra-uterine contraceptive device<br>* Other names: silverline IUD;|
| Other: control<br>patient not subjected to treatment . only follow up | Device: intra-uterine contraceptive device<br>* intra-uterine contraceptive device<br>* Other names: silverline IUD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the duration of menstrual bleeding. | days of menstruation | 3 cycles ( 3 months / one month for each cycle) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra-uterine Device, Vitamin B 1