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

NCT05971680 — Phase 3, Unknown, 200 participants, Beni-Suef University

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RegistryNCT05971680
StatusUnknown
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment200 (Estimated)
SponsorBeni-Suef University (Other)
ConditionsIntra-uterine Device Complication
InterventionsVITAMIN B1 500mg, intra-uterine contraceptive device (Drug, device)
Datesstart 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
Locations1 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

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Vitamin B 1ExperimentalDrug: VITAMIN B1 500mg; Device: intra-uterine contraceptive deviceVITAMIN B1 (High Potency) 500mg
controlOtherDevice: intra-uterine contraceptive devicepatient not subjected to treatment . only follow up
  • VITAMIN B1 500mg (Drug), also known as VITAMIN B1 500mg @Biovea: VITAMIN B1 (High Potency) 500mg tab every day for 3 months
  • intra-uterine contraceptive device (Device), also known as silverline IUD: intra-uterine contraceptive device

+Outcome measures

Primary outcomes

  • the duration of menstrual bleeding. [3 cycles ( 3 months / one month for each cycle)]: days of menstruation

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Beni-suef university HospitalBanī Suwayf, Beni Suweif GovernorateEgypt