Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

Study Overview
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Brief Summary
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To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

Detailed Description
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Women may experience pain and technical difﬁculties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity

Official Title
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Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial

Conditions
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IUD Insertion

Intervention / Treatment
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* Drug: Dinoprostone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test. Exclusion Criteria: currently pregnant or were pregnant within 6 weeks of study entry had a prior attempted or successful IUD insertion had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD active vaginitis or cervicitis undiagnosed abnormal uterine bleeding pelvic inﬂammatory disease within the last 3 months ﬁbroids or other uterine abnormalities distorting the uterine cavity contraindication or allergy to dinoprostone.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dinoprostone<br>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. | Drug: Dinoprostone<br>* 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.<br>|
| Placebo Comparator: placebo<br>one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. | Drug: placebo<br>* one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference in the pain intensity scores between the study groups | the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain | 5 minutes |