Intrauterine Device Insertion: a Step for High Satisfaction

• ClinicalTrials.gov Identifier: NCT03383432
• Recruitment Status: Completed
• First Posted: December 26, 2017
• Last Update Posted: February 10, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohammed Khairy Ali, Assiut University

Study Description

Brief Summary:

The intrauterine device is a safe, reliable and long-acting reversible contraceptive method. Instrumentation of lower genital mucosa during intrauterine device application provokes pain because it is highly sensitive to touch. Fear of pain associated with intrauterine device insertion is considered a barrier to use this contraception method.

The classic insertion instructions recommend performing bimanual examination and uterine sounding prior to intrauterine device insertion in order to confirm proper determination of uterine size and position. The pain during intrauterine device insertion could be due to cervical grasping by the tenaculum, traction on the cervical canal, stretching of the internal os by the uterine sound or the intrauterine device inserter, and lastly by irritation of the endometrial lining by the intrauterine device.

Many studies investigated the use of various analgesics in different doses and routes of administration and found out that it has a significant impact on relieving of associated pain Some technical modifications have been emerged in trial to decrease pain during intrauterine device insertion. One of them is trans-abdominal ultrasound guided intrauterine device insertion which the participant with a full bladder is subjected to intrauterine device insertion under ultrasonographic guide without using tenaculum. This method effectively decreased the pain and time of intrauterine device insertion.

A recent method named "Uterine Sounding Sparing Approach" has been reported very recently in literature by Ali et al., 2017. In this method; the sonographer performs T transvaginal ultrasound to evaluate the uterine position and the endometrial length in the sagittal view of the uterus. The intrauterine device was inserted directly into the uterine cavity without using uterine sounding.

In spite of less pain reported by trans-abdominal ultrasound guided intrauterine device insertion (no vulsellum was used), this methods also have some drawbacks, firstly; the full bladder may displace the cervix upward making the intrauterine device application not quite easy and secondly; this method needs two investigators which may distress the women who wondering about this. These two drawbacks may decrease patient's and physician's satisfaction. The uterine sounding sparing approach lacks these two drawbacks which make it more satisfying.

From above evidence, there is a strong need to compare the satisfaction rate between the two mentioned approaches in trial to answer this question. Up to our knowledge; no randomized trial has been conducted or registered to compare the satisfaction rate between two above approaches.

Condition or disease	Intervention/treatment	Phase
Intrauterine Device	Device: Intrauterine device; Radiation: Ultrasound; Procedure: uterine sounding sparing technique	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Ultrasound-guided Approach Versus Uterine Sound-sparing Approach for Intrauterine Device Insertion a Randomized Clinical Trial
• Actual Study Start Date: June 1, 2019
• Actual Primary Completion Date: June 1, 2020
• Actual Study Completion Date: August 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Trans-abdominal ultrasound intrauterine device group.; Those will be subjected to intrauterine device insertion under trans-abdominal ultrasound guidance. In this method the participant will be asked to have a full bladder. Full bladder helps to displace the bowel out of the pelvis and acts as an acoustic window for high frequency sound waves and to straighten the angle between the uterine body and cervix in anteverted uterus, performing the function of the tenaculum. Then, then ultrasound will be done and the intrauterine device will be introduced vaginally under ultrasound vision.	Device: Intrauterine device; Copper T 380 A; Radiation: Ultrasound; Transabdominal ultrasound
Uterine Sounding Sparing intrauterine device group; The sonographer performs ultrasound using transvaginal probe to evaluate the uterine position and the endometrial length in the sagittal view of the uterus. The intrauterine device was inserted directly into the uterine cavity without using uterine sounding.	Device: Intrauterine device; Copper T 380 A; Procedure: uterine sounding sparing technique; we will insert intrauterine device without using the uterine sound and we will replace this step by ultrasound before insertion

Outcome Measures

Primary Outcome Measures :

1. Level of satisfaction of patients in both groups (satisfaction score) [ Time Frame: 5 minutes after intrauterine device insertion ]
   Measured by visual analogue like scale from 0 to 10

Secondary Outcome Measures :

1. Level of reported pain (visual analogue scale ) [ Time Frame: 5 minutes after intrauterine device insertion ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Women aged 18-49 years
2. Nonpregnant
3. Women did not receive any analgesics or misoprostol in the 24 hours prior to insertion.

Exclusion Criteria:

1. Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, fibroids
2. Allergy to Copper.

Contacts and Locations

Locations

Egypt

Women Health Hospital - Assiut university

Assiut, Egypt, 71111

Sponsors and Collaborators

Assiut University

More Information

• Responsible Party: Mohammed Khairy Ali, lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT03383432
• Other Study ID Numbers: IUD-TAUSSA
• First Posted: December 26, 2017
• Last Update Posted: February 10, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No