Contraceptive Device; Complications
Conditions
Keywords
IUD, Office hysteroscopy, Ultrasound, Pain
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.
Detailed description
The intrauterine device (IUD) is a commonly used long-acting, effective and reversible method of contraception. The recommended way to remove a IUD is by grasping the threads with forceps and applying gentle traction until the IUD is extracted from the external os. Absent of the threads at the time of IUD removal is reported in 4.5 to 18% of cases. If the IUD is present in the uterus and threads are not visible , its removal in the office setting can still be achieved in about 80% of patients with the use of alligator forceps or string retrieval devices, hooks or clamps. However, blind manipulation may cause uterine perforation . In cases where such devices have failed (retained IUD ), If in office extraction of IUD by these instruments failed, removal of this retained IUD in the operating room is often employed because cervical dilatation and regional or general anesthesia are needed. In the last decade, several studies reported in office extraction of retained IUD by office hysteroscopy or under ultrasound guidance. No studies compared the efficacy or safety of these procedures
Interventions
PROCEDUREOffice hysteroscopy
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.
PROCEDUREUltrasound guided
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.
Sponsors
Bedaya Hospital
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients with retained IUD
Exclusion criteria
* Active pelvic infection * Viable intrauterine pregnancy * Cervical pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | Immediately after the procedure | 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') |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of IUD extraction | Immediately after the procedure | Percentage of successfully extracted IUD (number of extracted IUDs / total number of retained IUDs) |
Countries
Egypt
Contacts
Primary ContactUsama M Fouda, Prof.
Outcome results
None listed