IUD Insertion Complication
Conditions
Brief summary
Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.
Detailed description
Misoprostol ( 400mcg ) vaginally administrated 3 hours prior to IUCD insertion increases the ease and success of insertion and decrease associated pain among women who had delivered only by elective caesarean section.
Interventions
DRUGmisoprostol
misoprostol 2 tablets
DRUGPlacebo
starch pills manufactured to mimic misoprostol 200 mg tablets
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* All women will be 20 to 40 years of age. * Desires IUCD placement and able to participate. * Negative pregnancy test. * Willing to follow- up in 6-8 weeks for a standard IUCD follow-up visit. * Delivered only by cesarean section.
Exclusion criteria
* Active cervical infection. * Current pregnancy. * Uterine anomaly. * Fibroid uterus. * Copper allergy/Wilson's disease. * Undiagnosed abnormal uterine bleeding. * Cervical or uterine cancer. * Allergy to misoprostol. * Previous vaginal delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of failed IUCD insertions regardless of the reason . | during insertion | pain reported by particiepant during insertion graded from 1 to 10 on visual analogue scale |
| the degree of difficulty of the IUCD insertion . | during insertion | Judged as the resistance of the internal cervical os experienced by the investigator and measured by a 5-point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| heavy bleeding | 7 days | heavy bleeding and blood clots |
| partial or total expulsion | 4 to 6 weeks | not insitu by U/S |
Countries
Egypt
Contacts
Primary Contactenas mahmoud, MBBCh
Outcome results
None listed