Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance

Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance Versus the Standard Technique for IUD Insertion

The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .

Study Overview

• Status: Not yet recruiting
• Conditions: Contraceptive Device
• Intervention / Treatment: Procedure: Vulsellum group; Procedure: Ultrasound group

Detailed Description

The intrauterine device (IUD) is an effective method of contraception. Pain experienced during IUD insertion is one of the main causes that limits its widespread use.

Pain during IUD insertion is caused by insertion of cusco vaginal speculum, sounding the uterus, application of vulsellum to grasp the cervix, the passage of the inserter tube through the cervical canal and uterine cavity..

In order to minimize the pain associated with IUD insertion , several studies reported that the use of ultrasound to guide the insertion of IUD into uterine cavity was associated with less pain and more accurate placement of IUD, other studies reported that filling the bladder during IUD insertion minimized the pain associated with IUD insertion.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Usama M Fouda, Prof.; Phone Number: +2 01095401375; Email: umfrfouda@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women requesting IUD insertion

Exclusion Criteria:

• Active pelvic infection
• Viable intrauterine pregnancy
• Uterine anomalies
• Uterine fibroid
• Wilson disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vulsellum group; The patients are asked to empty the bladder before IUD insertion. The vulsellum is applied on the cervix, sounding of the uterus is done and the IUD is inserted according to the standard technique of IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale.	Procedure: Vulsellum group; The patients are asked to empty the bladder before IUD insertion. The vulsellum is applied on the cervix, sounding of the uterus is done and the IUD is inserted according to the standard technique of IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale.
Active Comparator: Ultrasound group; During the two hour period before IUD insertion, the patients are asked to drink about one liter of water and to avoid micturition. Abdominal ultrasound is used to obtain a sagittal view of the uterus and the IUD is introduced into the uterine cavity under ultrasound guidance. The vulsellum and uterine sound are not used during IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale.	Procedure: Ultrasound group; During the two hour period before IUD insertion, the patients are asked to drink about one liter of water and to avoid micturition. Abdominal ultrasound is used to obtain a sagittal view of the uterus and the IUD is introduced into the uterine cavity under ultrasound guidance. The vulsellum and uterine sound are not used during IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of IUD insertion	( number of successfully inserted IUD / total number of IUD insertion attempts)	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Bedaya Hospital
• Investigators: Principal Investigator: Usama M Fouda, Prof., Cairo University

Publications and helpful links

General Publications

• Baradwan S, Alshahrani MS, Alnoury A, Khadawardi K, Khan MA, Abdelkader RAA, Saleh OI, Galal HM, Mohamed SMA, Abdelhakim AM, Elgedawy AM, Elbahie AM, Gaber MA, Magdy AA, Shaheen K. Does Ultrasound Guidance Provide Pain Relief During Intrauterine Contraceptive Device Insertion? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Ultrasound Med. 2023 Jul;42(7):1401-1411. doi: 10.1002/jum.16166. Epub 2022 Dec 30.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Pain; IUD; Full bladder
• Other Study ID Numbers: IUD/Ultrasound

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No