Evaluating an IUD insertion procedure

Phase 4

Completed

• Registration Number: CTRI/2023/02/049403
• Lead Sponsor: Pregna International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-11
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 166

Inclusion Criteria

Subjects who meet all the following inclusion criteria may be included:

1. 18 years old or older, in good general health and requesting contraception.

2. Meets World Health Organization (WHO) medical eligibility criteria for contraceptive use

3. Desires IUD placement

4. Negative urinary pregnancy test

5. No pelvic inflammatory disease (PID) in last 3 months

6. No contraindications to IUD insertion (see exclusion criteria below)

7. Is willing to complete survey during and after the insertion

8. Is willing to attend follow-up visit at 4-6 weeks after insertion

Exclusion Criteria

Subjects who met any of the following exclusion criteria will not be included that:

1. Malignant disease of the genital tract

2. Undiagnosed vaginal bleeding,

3. Anaemia, coagulation disorder

4. Pregnancy (known or suspected)

5. Post-partum with no menstrual return (less than 3 months)

6. Recent (less than 3 months) abortion

7. Ongoing or recent (less than 3 months) infection of the genital tract

8. Sexually transmitted disease during the last 12 months (except bacterial vaginitis, repeats

herpes infection, Hepatitis B)

9. Pelvic inflammatory disease.

10. Uterine malformation (congenital or acquired)

11. Allergy to copper

12. Known pelvic tuberculosis

13. Benign and Malignant trophoblast disease

14. Distorted uterine cavity

15. Acute purulent discharge

16. Vesicovaginal fistula

17. Third degree uterine prolapse

18. Systemic Lupus Erythematosus with sever thrombocytopenia

19. Ovarian cancer

20. High individual risk of chlamydia and gonococcal infection (partner has current purulent

discharge or STI)

21. Heavy/prolonged or painful menstrual bleeding, endometriosis, severe dysmenorrhea

22. AIDS, without antiretroviral therapy nor access to care

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The investigation study intends to measure the correct IUD insertion <br/ ><br>Timepoint: Base line/Immediately post insertion <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1) The investigation study intends to measure the participant pain level during IUD <br/ ><br>insertion <br/ ><br>? 2) The investigation study intends to measure the participant satisfaction with the <br/ ><br>intervention procedure <br/ ><br>? 3) The investigation study intends to measure the provider satisfaction with the <br/ ><br>intervention procedureTimepoint: Onsite follow-up 4-6 weeks after insertion. <br/ ><br>Distance 6 months and 12 months <br/ ><br>