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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05971680

Enrollment

200

Registered

2023-08-02

Start date

2023-07-30

Completion date

2023-11-30

Last updated

2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-uterine Device Complication

Keywords

Intra-uterine Device, Vitamin B 1

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.

Interventions

DRUGVITAMIN B1 500mg

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

DEVICEintra-uterine contraceptive device

intra-uterine contraceptive device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactBeni-suef University

fom@med.bsu.edu.eg082 2318605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026