To study safety and performance of Intrauterine Contraceptive Device.

Single arm, Open label, Multicentre, Prospective Observational study to evaluate safety and performance of Intrauterine Contraceptive Device

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/09/045810

Enrollment

357

Registered

2022-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

None listed

Interventions

Intervention1: Intrauterine Contraceptive Device:T cu 380 A with Safe Load, CU 375 Sleek, Cu 380 Ag, Mini Cu 380 Ag ,Cu 380, Mini Cu 380: IUDs offer almost complete protection against pregnancy, havin

Eligibility

Inclusion criteria

Inclusion criteria: Adult female of any reproductive age (21-45 years of age) Women who require contraception Women at high risk of pregnancy

Exclusion criteria

Exclusion criteria: Subjects with malignant diseases of the genital tract Subjects with undiagnosed vaginal bleeding - Subjects who are pregnant Subjects with past history of ectopic pregnancy or predisposing factors. Subjects with infections of the genital tract Subjects with sexually transmitted diseases during the last 12 months (except bacterial vaginitis, repeated herpes infection, Hepatitis B) Subjects with abortion with infection during the last 3 months, pelvic inflammatory disease Subjects with uterine malformations (congenital or acquired) Subjects with allergy to copper Subjects with Anemia Subjects with valvular heart disease Subjects with coagulation disorders Subjects with anti-inflammatory treatment - Subjects with Wilson?s disease Subjects with multiple exposures to different sexual partners Subject not willing for IUD insertion.

Design outcomes

Primary

Measure	Time frame
The primary objective of this post market clinical study is to assess the clinical performance and safety of the Intrauterine Contraceptive Device. Duration of the study will be 5 year.Timepoint: There will be six follow up visits after the insertion of IUD after one month, 1st year, 2nd year, 3rd year, 4th year and 5th year.During the follow up visit of one year, second year, third year, fourth year and fifth year the reversible fertility condition also will be verified in those subjects who had removed the IUD?s during these years. Duration of the study will be 5 years.	—

Measure

Time frame

The primary objective of this post market clinical study is to assess the clinical performance and safety of the Intrauterine Contraceptive Device. Duration of the study will be 5 year.Timepoint: There will be six follow up visits after the insertion of IUD after one month, 1st year, 2nd year, 3rd year, 4th year and 5th year.During the follow up visit of one year, second year, third year, fourth year and fifth year the reversible fertility condition also will be verified in those subjects who had removed the IUD?s during these years. Duration of the study will be 5 years.

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Secondary

Measure	Time frame
The Secondary Objective is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device.Timepoint: There will be six follow up visits after the insertion of IUD after one month, 1st year, 2nd year, 3rd year, 4th year and 5th year.During the follow up visit of one year, second year, third year, fourth year and fifth year the reversible fertility condition also will be verified in those subjects who had removed the IUD?s during these years. Duration of the study will be 5 years.	—

Measure

Time frame

The Secondary Objective is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device.Timepoint: There will be six follow up visits after the insertion of IUD after one month, 1st year, 2nd year, 3rd year, 4th year and 5th year.During the follow up visit of one year, second year, third year, fourth year and fifth year the reversible fertility condition also will be verified in those subjects who had removed the IUD?s during these years. Duration of the study will be 5 years.

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Countries

India

Contacts

Public ContactDr Lakshmi Prasanna

gynaecologist & Obstetrician at Sri Clinic, Hyderabad

Lakshmiyadavalli2008@gmail.com9949132433

Outcome results