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OpenTrials
Completed

NCT Number: NCT02841826

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

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.

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Key information

Conditions

Contraception

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IUD

Other

Uterine sounding

Other

Transvaginal ultrasound

Radiation

Primary outcomes

  1. The degree of pain perception measured visual analogue score

    Time frame: 15 minutes

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2016
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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