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Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance

NCT06554249 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-08-15

No results posted yet for this study

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 .

Conditions

  • Contraceptive Device

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..

Sponsors & Collaborators

  • Bedaya Hospital

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Usama M Fouda, Prof. · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-06-15
Completion
2025-06-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554249 on ClinicalTrials.gov