| Registry | NCT05971680 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 200 (Estimated) |
| Sponsor | Beni-Suef University (Other) |
| Conditions | Intra-uterine Device Complication |
| Interventions | VITAMIN B1 500mg, intra-uterine contraceptive device (Drug, device) |
| Dates | start 2023-07-30 (estimated), primary completion 2023-11-30 (estimated), completion 2023-11-30 (estimated), first posted 2023-08-02, last updated 2023-08-02 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Intra-uterine Device Complication All trials of VITAMIN B1 500mg All trials of intra-uterine contraceptive device
investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vitamin B 1 | Experimental | Drug: VITAMIN B1 500mg; Device: intra-uterine contraceptive device | VITAMIN B1 (High Potency) 500mg |
| control | Other | Device: intra-uterine contraceptive device | patient not subjected to treatment . only follow up |
Sex: Female, ages: 20 Years to 40 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beni-suef university Hospital | Banī Suwayf, Beni Suweif Governorate | Egypt |