Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vulsellum group, Ultrasound group.
- Who it may be relevant to
- Registry conditions: Contraceptive Device. Basic parameters: 18 years — 48 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance Versus the Standard Technique for IUD Insertion
Overview
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 .
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.
Interventions
- 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. - 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..
Primary outcome measures
- Intensity of pain [Time frame: Immediately after the procedure]
Secondary outcome measures (1)
- Success of IUD insertion [Time frame: Immediately after the procedure]
Eligibility criteria
Inclusion criteria
- Women requesting IUD insertion
Exclusion criteria
- Active pelvic infection
- Viable intrauterine pregnancy
- Uterine anomalies
- Uterine fibroid
- Wilson disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of medicine, Cairo university — Cairo
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 PMID 36583454
Identifiers
NCT: NCT06554249 · IUD/Ultrasound