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

NCT ID: NCT05971680

Last Updated: 2023-08-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2023-11-30

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.

Conditions

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Intra-uterine Device Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin B 1

VITAMIN B1 (High Potency) 500mg

Group Type EXPERIMENTAL

VITAMIN B1 500mg

Intervention Type DRUG

VITAMIN B1 (High Potency) 500mg tab every day for 3 months

intra-uterine contraceptive device

Intervention Type DEVICE

intra-uterine contraceptive device

control

patient not subjected to treatment . only follow up

Group Type OTHER

intra-uterine contraceptive device

Intervention Type DEVICE

intra-uterine contraceptive device

Interventions

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VITAMIN B1 500mg

VITAMIN B1 (High Potency) 500mg tab every day for 3 months

Intervention Type DRUG

intra-uterine contraceptive device

intra-uterine contraceptive device

Intervention Type DEVICE

Other Intervention Names

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VITAMIN B1 500mg @Biovea silverline IUD

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Beni-suef University

Role: CONTACT

082 2318605 ext. 02

Other Identifiers

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Vitamin B 1 IUD

Identifier Type: -

Identifier Source: org_study_id

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