Intrauterine Device Insertion and Felt Pain

Intrauterine Device Migration Clinical Trial

Official title:

Intrauterine Device Insertion and Felt Pain: Which Method is Better?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956184
• Other study ID #: ACH-KHD-MIH-01
• Status: Completed
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.

Description:

The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.

Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.

In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Volunteer to participate in the study

• Preferring an intrauterine device for the contraceptive method

Exclusion Criteria:

• Patients with uterine leiomyoma

• Patients with endometriosis

• Patients with chronic pelvic pain

• Patients with familial mediterranean fever

• Patients who experienced complications during the procedure

• Patients who developed vasovagal reactions

• Patients who had previously used an IUD for any reason

• Patients with uterine anomalies

Related Conditions & MeSH terms

• Intrauterine Device Migration

Intervention

Device:
• Intrauterine Device Insertion
All womens will be placed in a gynecological position and underwent a bimanual examination to better determine whether the uterus was in the anteverted or retroverted position. Subsequently, a speculum will be inserted, and the cervix will be disinfected with betadine. In the conventional method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD is inserted. In the direct method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and without using hysterometry the IUD is directly inserted. The strings will be cut approximately 2-3 cm after the cervix, and the Pozzi forceps and speculum will be removed. The accuracy of the IUD placement will be confirmed using pelvic ultrasound. The process will take about five minutes.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	This is a numeric pain score evaluated as "painless" (score=0) and "worst pain" (score=10). Score <3 mild pain, 3-6 mild-moderate pain, and >6 moderate-to-severe pain.	Thirty minutes