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Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

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ClinicalTrials.gov Identifier: NCT02842177
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Study Description
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Brief Summary:

The intrauterine devices 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 intrauterine devices 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 intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices .

Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks.

Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.


Condition or disease Intervention/treatment Phase
Contraception Procedure: Classic group Procedure: Uterine sounding sparing group Radiation: Transvaginal ultrasound Device: Cu-IUD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device
Actual Study Start Date : January 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group I (classic method) Procedure: Classic group
The speculum was placed into the vagina and the cervix was cleansed with povidone iodine. After placement of single toothed vulsellum on the anterior lip of the cervix, for traction and fixation of the uterus, the uterine sound was inserted for determination of uterine length and uterine position followed by Cu-IUD insertion. The duration of IUD insertion were reported.

Device: Cu-IUD
Active Comparator: uterine sound sparing group Procedure: Classic group
The speculum was placed into the vagina and the cervix was cleansed with povidone iodine. After placement of single toothed vulsellum on the anterior lip of the cervix, for traction and fixation of the uterus, the uterine sound was inserted for determination of uterine length and uterine position followed by Cu-IUD insertion. The duration of IUD insertion were reported.

Procedure: Uterine sounding sparing group
after bimanual examination, the same sonographer (Level II experience) performed transvaginal /US using a SonoAce X6 machine (Medison, Korea) with transvaginal probe (4-8 MHz frequency, using an average 6.5 MHz). Firstly, he evaluated the uterine position. Then, he measured the endometrial and cervical stripe lengths in the sagittal view of the uterus and summed to have the actual length of the uterus; by which the IUD tube was adjusted before insertion.The same speculum and vulsellum were used and the IUD was inserted directly into the uterine cavity.

Radiation: Transvaginal ultrasound
Device: Cu-IUD


Outcome Measures
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Primary Outcome Measures :
  1. Successful intrauterine device insertion [ Time Frame: 5 minutes ]
    defined by a distance from the intrauterine device to the end of endometrial line of less than 25 mm The degree of total pain perception during intrauterine contraceptive insertion measured by visual analogue scale


Secondary Outcome Measures :
  1. The degree of pain during intrauterine device insertion [ Time Frame: 5 minutes ]
    measured by Visual Analog Pain Scale

  2. the duration of intrauterine device insertion [ Time Frame: 5 minutes ]
    The time between start of IUD insertion and the end of the procedure


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women requesting intrauterine contraceptive device as a contraction

Exclusion Criteria:

  • Uterine abnormalities
  • Endometrial lesions,
  • Adenomyosis
  • Fibroids
  • Intrauterine adhesions.
  • Chronic pelvic pain
  • Spasmodic dysmenorrhea
  • History of cervical surgery
Contacts and Locations
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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): NCT02842177


Locations
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Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02842177    
Other Study ID Numbers: NIUD
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes