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

Beni-Suef University

Status and phase: Not yet enrolling; Phase 3

Conditions: Intra-uterine Device Complication

Treatments: Device: intra-uterine contraceptive device; Drug: VITAMIN B1 500mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05971680

Vitamin B 1 IUD

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Vitamin B 1

Experimental group

Description:

VITAMIN B1 (High Potency) 500mg

Treatment:

Drug: VITAMIN B1 500mg

Device: intra-uterine contraceptive device

control

Other group

Description:

patient not subjected to treatment . only follow up

Treatment:

Device: intra-uterine contraceptive device