NCT06550544

Brief Summary

The aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Various subgroups (patients who delivered only by Caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.

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
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

April 11, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

August 21, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

April 11, 2024

Last Update Submit

August 9, 2024

Conditions

Contraceptive Device; Complications

Keywords

IUDOffice hysteroscopyUltrasoundPain

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Measured after the procedure using a 10 cm Visual analogue scale ( where 0 indicates no pain') and 10 indicates a 'pain as bad as it could possibly be')

    Immediately after the procedure

Secondary Outcomes (1)

  • Success of IUD extraction

    Immediately after the procedure

Study Arms (2)

Office hysteroscopy

ACTIVE COMPARATOR

A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. Vaginoscopic approach will be used. A 5 F grasper will be used to grasp and extract the IUD. .Pain intensity will be assessed by visual analogue scale immediately after the procedure.

Procedure: Office hysteroscopy

Ultrasound guided

ACTIVE COMPARATOR

An alligator forceps will be introduced into the uterine cavity under ultrasound sound guidance. The IUD will be grasped and extracted outside the uterus. .Pain intensity will be assessed by visual analogue scale immediately after the procedure.

Procedure: Ultrasound guided

Interventions

Office hysteroscopyPROCEDURE

A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. Vaginoscopic approach will be used. A 5 F grasper will be used to grasp and extract the IUD. Pain intensity will be assessed by visual analogue scale immediately after the procedure.

Office hysteroscopy
Ultrasound guidedPROCEDURE

An alligator forceps will be introduced into the uterine cavity under ultrasound sound guidance. The IUD will be grasped and extracted outside the uterus. Pain intensity will be assessed by visual analogue scale immediately after the procedure.

Ultrasound guided

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with retained IUD

You may not qualify if:

  • Active pelvic infection
  • Viable intrauterine pregnancy
  • Cervical pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, Egypt

Location

Related Publications (1)

  • Townsend L, Luxford E, Mizia K. Effectiveness of ultrasound-guided removal of intrauterine devices. Aust N Z J Obstet Gynaecol. 2022 Oct;62(5):800-802. doi: 10.1111/ajo.13584. Epub 2022 Jul 11.

    PMID: 35815357BACKGROUND

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

April 11, 2024

First Posted

August 13, 2024

Study Start

August 21, 2024

Primary Completion

February 20, 2025

Study Completion

February 21, 2025

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)