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Clinical Trials/NCT02841826
NCT02841826
Completed
Phase 2

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

Assiut University1 site in 1 country90 target enrollmentJanuary 2016
ConditionsContraception

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Contraception
Sponsor
Assiut University
Enrollment
90
Locations
1
Primary Endpoint
The degree of pain perception measured visual analogue score
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Khairy Ali

Dr

Assiut University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The degree of pain perception measured visual analogue score

Time Frame: 15 minutes

Study Sites (1)

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