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

Intra-uterine Device Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05971680
• Other study ID #: Vitamin B 1 IUD
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 30, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: Beni-Suef University
• Contact: Beni-suef University
• Phone: 082 2318605
• Email: fom[@]med.bsu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intra-uterine Device Complication

Intervention

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

Device:
• intra-uterine contraceptive device
intra-uterine contraceptive device

Locations

Country	Name	City	State
Egypt	Beni-suef university Hospital	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the duration of menstrual bleeding.	days of menstruation	3 cycles ( 3 months / one month for each cycle)