NCT05971680

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intra-uterine Device Complication

Interventions

Type	Name	Description
DRUG	VITAMIN B1 500mg	VITAMIN B1 (High Potency) 500mg tab every day for 3 months
DEVICE	intra-uterine contraceptive device	intra-uterine contraceptive device

Timeline

• Start date: 2023-07-30
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2023-08-02
• Last updated: 2023-08-02

Locations

1 site across 1 country: Egypt