Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with retained IUD

Disqualifiers

Active pelvic infection

Viable intrauterine pregnancy

Cervical pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Office hysteroscopy

    Procedure/Surgery

    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.

  • Ultrasound guided

    Procedure/Surgery

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Office hysteroscopyActive comparator 1 intervention
Group B: Ultrasound guidedActive comparator 1 intervention

Trial outcomes

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')

Time frame
Immediately after the procedure

Secondary outcomes

1

Success of IUD extraction

Percentage of successfully extracted IUD (number of extracted IUDs / total number of retained IUDs)

Time frame
Immediately after the procedure

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

Bedaya Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: