Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.
- Registration Number
- NCT03939663
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 210
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Placebo 2 tablets vaginally misoprostol group misoprostol 400 mcg vaginally
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method heavy bleeding 7 days heavy bleeding and blood clots
partial or total expulsion 4 to 6 weeks not insitu by U/S
Trial Locations
- Locations (1)
Enas Mahmoud
🇪🇬Cairo, Egypt