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Evaluation of insertion of an Intrauterine contraceptive device using cross glide technology

A prospective, pilot, interventional, single arm study to evaluate the insertion of intrauterine contraceptive device using the cross glide technology - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/060997
Enrollment
30
Registered
2024-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

None listed

Interventions

Intervention1: Yanae® Cu 380 IUD: Yanae® was created by combining the Crossglide™ insertor and a 380 Y copper IUD. The copper containing IUD is placed via this crossglide inserter which doesnt requir

Sponsors

Department of Obstetrics and Gynaecology, PGIMER, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women desirous of long-term reversible contraception. 2.Patients who fulfil the WHO ‘Medical eligibility criteria for contraceptive use’ (Annexure I). 3.Patients who are willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Women who are not willing to participate in the study. 2. Women with structural malformations of the uterus, cervix and vagina and presence of fibroids. 13 3. Women with severe anaemia, uncontrolled diabetes, thrombocytopenia, any bleeding disorder. 4. Women with active genital tract infection/ pelvic inflammatory disease (PID). 5. Women with concurrent pregnancy. 6. Women with genital tract bleeding of unknown cause. 7. Women with prior history of ectopic pregnancy/ scarred uterus.

Design outcomes

Primary

MeasureTime frame
To assess the proper placement of the IUD in the uterus with the newer cross glide technique.Timepoint: immediately after insertion procedure & after 6 weeks of insertion procedure.

Secondary

MeasureTime frame
To assess the VAS score for pain perceived by the patient and ease of insertion for the doctor.Timepoint: immediately after the insertion procedure.

Countries

India

Contacts

Public ContactMadugula Kavya

Post graduate institute of medical education and research, chandigarh

drvanitajain@yahoo.com9914209352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026