None listed
Conditions
Interventions
Intervention1: Intrauterine contraceptive Devices (Copper T 380A): a single copper sleeve is swaged on
each of the two transverse arms. The device is 32mm wide and 36 mm long, with a plastic ball
at t
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy women aged 18-45 years of age and only female gender are enrolled in the study. 2.Women desired to use the MeriTe• Cu T 380A IUD as a Long-Acting Reversible Contraceptive (LARC) method. 3.Subjects who undergo ultrasound at baseline are included in the study. 4.Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form. 5.The subject is willing and able to comply with postinsertion scheduled clinical evaluations.
Exclusion criteria
Exclusion criteria: 1.Women under the age of 18 are excluded. 2.The subject has pregnancy or suspicion of pregnancy are not advised to take IUDs. 3.Lactating women are excluded from the study. 4.Postmenopausal women are excluded from the study. 5.History of trophoblastic disease 6.Subjects having a history of irregular menstrual cycle, infertility, and ectopic pregnancies are excluded from the study. 7.Subjects used any long-acting injectable sex-hormone preparations within 9 months are excluded from the study. 8.The subject is diagnosed with abnormalities of the uterus, resulting in distortion of the uterine cavity and vaginal abnormalcy (unicornuate, bicornuate, didelphys, or septate uterus). 9.Subjects having a history of alcohol or drug abuse are excluded from the study. 10.The subject has acute pelvic inflammatory disease or current behavior suggesting a high risk for pelvic inflammatory disease is not included in the study. 11.Subjects having a history of post-partum endometritis or postabortal endometritis in the past 6 months are excluded. 12.Subjects who are known or suspected of uterine or cervical malignancy should not be taken into the study. 13.Subjects having genital bleeding of unknown etiology, mucopurulent cervicitis, and Wilsonâ??s disease are excluded from the study. 14.Any subject who has an allergy to any component of MeriTe• Cu T 380A. 15.If the subject is experiencing significant post-partum pain and/or bleeding due to infection or other causes, she should be excluded before insertion. 16.The subject is unwilling or unable to sign the Informed Consent Document. 17.Post-partum insertions should be postponed until the uterus is fully involuted. Do not insert earlier than six weeks after delivery. 18. Women diagnosed with AIDS should not insert IUDs unless they are clinically stable on antiretroviral therapy. 19.Subjects whose life expectancy is less than 5 years of age, such as cancer patients, are excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Pregnancy RateTimepoint: 1. Time Frame: 1 month, 3 months, 6 months, and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pregnancy rate 2. Expulsion, Mal position, and Perforation 3. Change in the menstrual pattern before and after insertion of IUD device 4. Discontinuation rate 5. Subject satisfaction will be evaluated on a scale from 1 to 5 in a questionnaire form 6. Adverse events 7. Physicians assessment of ease of placement defined as an easy, moderate or difficult placement Timepoint: Time Frame: Intra procedure , Pre procedure, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed