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

Phase 3

Not yet recruiting

• Conditions: Intra-uterine Device Complication
• Interventions: Drug: VITAMIN B1 500mg; Device: intra-uterine contraceptive device

• Registration Number: NCT05971680
• Lead Sponsor: Beni-Suef University

Brief Summary

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

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 Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Last Update Submitted: 2023-07-25
• Study Start: 2023-07-30
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin B 1	VITAMIN B1 500mg	VITAMIN B1 (High Potency) 500mg
Vitamin B 1	intra-uterine contraceptive device	VITAMIN B1 (High Potency) 500mg
control	intra-uterine contraceptive device	patient not subjected to treatment . only follow up

Primary Outcome Measures

Name	Time	Method
the duration of menstrual bleeding.	3 cycles ( 3 months / one month for each cycle)	days of menstruation

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Beni Suef, Egypt