Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery:a Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Dinoprostone 3 mg
- Conditions
- IUD Pain
- Sponsor
- Cairo University
- Enrollment
- 300
- Primary Endpoint
- The difference in pain scores during intrauterine device insertion
- Last Updated
- 6 years ago
Overview
Brief Summary
To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in women delivered only by cesarean section.
Detailed Description
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
Investigators
Ahmed Samy aly ashour
assistant professor
Cairo University
Eligibility Criteria
Inclusion Criteria
- •women delivered only by elective cesarean section and not received analgesics in the last 24 hours
Exclusion Criteria
- •contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.
Arms & Interventions
dinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
Intervention: Dinoprostone 3 mg
misoprostol
1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
Intervention: Misoprostol 200Mcg Tab
placebo
one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.
Intervention: placebo
Outcomes
Primary Outcomes
The difference in pain scores during intrauterine device insertion
Time Frame: 10 minutes
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10