Silver T IUD for Family Planning

Phase III Clinical Trial of SMB T Cu 380Ag IUD in 3 Sizes/Models Mini, Normal and Maxi to evaluate the safety in respect of Insertion, Expulsion and Side effect of SMB TCu 380Ag IUD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/09/006180

Enrollment

800

Registered

2015-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Intra uterine Contraceptive Devices (TCu 380Ag): Each y Shaped IUD made from Compound of LDPE and BaSO4 wound with 0.40 mm diameter Copper wire with Silver core providing a surface area

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Females of child bearing age, Age Group : 20 years to 35 years, Free and willing to fully comply with treatment process, Married or in a steady relationship, One Child interval or post delivery (PP IUCD), Immediately after MTP/Immediately after Postpartum, 5 â?? 8 day of menses

Exclusion criteria

Exclusion criteria: Any uterus pathogens like fibroid, adenomyosis, Patient with strong history of menorrhagia Use as an emergency contraception, A previously placed IUD that has not been removed, Pregnancy or suspicious of pregnancy, Use of other contraceptive method,

Design outcomes

Primary

Measure	Time frame
The assessment of insertion, expulsion and side effects of product with patientâ??s follow-up period of one year in comparison with the Copper T 380A will be done for evaluation of the continuation rate and acceptability of the method used at 1 year.Timepoint: The follow up visit by the subjects should be quarterly basis as follows: 1. First visit after 1 month of Insertion 2. 2nd Visit after 3 months of Insertion 3. 3rd visit after 6 months of Insertion 4. 4th visit after 9 months of Insertion 5. 5th visit after 12 months of Insertion	—

Measure

Time frame

The assessment of insertion, expulsion and side effects of product with patientâ??s follow-up period of one year in comparison with the Copper T 380A will be done for evaluation of the continuation rate and acceptability of the method used at 1 year.Timepoint: The follow up visit by the subjects should be quarterly basis as follows: 1. First visit after 1 month of Insertion 2. 2nd Visit after 3 months of Insertion 3. 3rd visit after 6 months of Insertion 4. 4th visit after 9 months of Insertion 5. 5th visit after 12 months of Insertion

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Secondary

Measure	Time frame
Complete expulsion is defined as IUCD in vagina. And partial expulsion is defined as IUCD in cervical canal. Pelvic infection is defined as purulent discharge from the cervix, cervical and uterine tenderness, and tender adnexal mass. Uterine perforation and pelvic infection will be treated as adverse events and recorded. Additional information will be recorded as dysmenorrhea, need for analgesia, and initiation of sexual activity prior to IUCD insertion satisfaction with method used.Timepoint: Menstrual flow will be recorded as none, scanty, normal or heavy bleeding (more than normal menstrual flow as per woman experience). Prolonged bleeding is defined by bleeding more than 7 days.	—

Measure

Time frame

Complete expulsion is defined as IUCD in vagina. And partial expulsion is defined as IUCD in cervical canal. Pelvic infection is defined as purulent discharge from the cervix, cervical and uterine tenderness, and tender adnexal mass. Uterine perforation and pelvic infection will be treated as adverse events and recorded. Additional information will be recorded as dysmenorrhea, need for analgesia, and initiation of sexual activity prior to IUCD insertion satisfaction with method used.Timepoint: Menstrual flow will be recorded as none, scanty, normal or heavy bleeding (more than normal menstrual flow as per woman experience). Prolonged bleeding is defined by bleeding more than 7 days.

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Countries

India

Contacts

Public ContactDr CN Purandare

President Elect FIGO,Dean Indian College of Obstetricians and Gynaecologists

dr.c.n.purandare@gmail.com9820088183

Outcome results