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

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05971680
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
4
Anticipated Duration (Months)
49.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: VITAMIN B1 500mg
  • Device: intra-uterine contraceptive device
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.
Anticipated Study Start Date :
Jul 30, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin B 1

VITAMIN B1 (High Potency) 500mg

Drug: VITAMIN B1 500mg
VITAMIN B1 (High Potency) 500mg tab every day for 3 months
Other Names:
  • VITAMIN B1 500mg @Biovea

    • Device: intra-uterine contraceptive device
    intra-uterine contraceptive device
    Other Names:
  • silverline IUD

    		•
    Other: control

    patient not subjected to treatment . only follow up

    Device: intra-uterine contraceptive device
    intra-uterine contraceptive device
    Other Names:
  • silverline IUD

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the duration of menstrual bleeding. [3 cycles ( 3 months / one month for each cycle)]

      days of menstruation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-suef university Hospital Banī Suwayf Beni Suef Egypt 62521

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05971680
    Other Study ID Numbers:
    • Vitamin B 1 IUD
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    Intra-uterine Device
    Vitamin B 1
    Additional relevant MeSH terms:
    Vitamins
    Thiamine
    Vitamin B Complex
    Contraceptive Agents

    Study Results

    No Results Posted as of Aug 2, 2023