Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women

Study Overview
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Brief Summary
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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 multiparous overweight and obese women

Detailed Description
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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.

Official Title
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Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Overweight and Obese Women :a Randomized Controlled Trial

Conditions
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IUCD Complication

Intervention / Treatment
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* Drug: dinoprostol
* Drug: misoprostol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: multi parous women requesting copper IUD insertion body mass index more than 25 Exclusion Criteria: pregnancy, null parous women, contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, untreated active cervicitis or vaginitis, undiagnosed abnormal uterine bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dinoprostone<br>2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion. | Drug: dinoprostol<br>* 2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.<br>* Other names: prostin;|
| Active Comparator: misoprostol<br>2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion. | Drug: misoprostol<br>* 2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.<br>* Other names: Misotac;|
| Placebo Comparator: placebo<br>Placebo Comparator: placebo 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion. | Drug: placebo<br>* 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion<br>* Other names: placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in visual analog scale pain scores during intrauterine device insertion | The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 | 10 minuts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain: visual analogue scale | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 | 30 minutes after the procedure | 
| the difference in visual analog scale pain scores during tenaculum application | The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10 | 10 minutes | 
| the ease of IUD insertion | the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion) | 10 minutes | 
| women's satisfaction level: score | women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction | 10 minutes |