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Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02841826
Enrollment
90
Registered
2016-07-22
Start date
2016-01-31
Completion date
2016-07-31
Last updated
2016-11-25

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

Conditions

Contraception

Brief summary

The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years. The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia. The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.

Interventions

OTHERIUD
OTHERUterine sounding
RADIATIONTransvaginal ultrasound

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Women requesting intrauterine contraceptive device as a contraction * Women accepted participation in the study

Exclusion criteria

* Uterine abnormalities * Endometrial lesions as polyp * Adenomyosis * Fibroids distorting the cavity * Intrauterine adhesions. * Chronic pelvic pain * Dysmenorrhea * History of cervical surgery

Design outcomes

Primary

MeasureTime frame
The degree of pain perception measured visual analogue score15 minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026