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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841826
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

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.


Condition or disease Intervention/treatment Phase
Contraception Other: IUD Other: Uterine sounding Radiation: Transvaginal ultrasound Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Group I: IUD without uterine sound group
Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.
Other: IUD
Radiation: Transvaginal ultrasound
Group II: IUD with uterine sound
Intrauterine contraceptive device inserted by classic method
Other: IUD
Other: Uterine sounding



Primary Outcome Measures :
  1. The degree of pain perception measured visual analogue score [ Time Frame: 15 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841826


Locations
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Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02841826    
Other Study ID Numbers: PIUD
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes