NCT06554249

Brief Summary

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 9, 2024

Last Update Submit

August 13, 2024

Conditions

Contraceptive Device

Keywords

IUDUltrasoundFull bladderPain

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

    Immediately after the procedure

Secondary Outcomes (1)

  • Success of IUD insertion

    Immediately after the procedure

Study Arms (2)

Vulsellum group

ACTIVE COMPARATOR

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

Ultrasound group

ACTIVE COMPARATOR

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

Interventions

Vulsellum groupPROCEDURE

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.

Vulsellum group
Ultrasound groupPROCEDURE

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..

Ultrasound group

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women requesting IUD insertion

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Cairo university

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 36583454BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Usama M Fouda, Prof.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Usama M Fouda, Prof.

CONTACT

01095401375umfrfouda@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 15, 2024

Study Start

October 15, 2024

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)