the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.
NCT ID: NCT05971680
Last Updated: 2023-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2023-07-30
2023-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vitamin B 1
VITAMIN B1 (High Potency) 500mg
VITAMIN B1 500mg
VITAMIN B1 (High Potency) 500mg tab every day for 3 months
intra-uterine contraceptive device
intra-uterine contraceptive device
control
patient not subjected to treatment . only follow up
intra-uterine contraceptive device
intra-uterine contraceptive device
Interventions
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VITAMIN B1 500mg
VITAMIN B1 (High Potency) 500mg tab every day for 3 months
intra-uterine contraceptive device
intra-uterine contraceptive device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 bleeding disorders.
* Patients with systemic diseases.
20 Years
40 Years
FEMALE
No
Sponsors
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Beni-Suef University
OTHER
Responsible Party
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Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Locations
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Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, Egypt
Countries
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Central Contacts
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Other Identifiers
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Vitamin B 1 IUD
Identifier Type: -
Identifier Source: org_study_id
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