Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous 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 nulliparous 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.n American College of Obstetricians and Gynecologists committee opinion encourages providers to use IUDs as a ﬁrst line of contraception in nulliparous women.

Official Title
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Effects of Prophylactic Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

Conditions
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Intrauterine Device

Intervention / Treatment
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* Drug: Dinoprostone 3 mg
* Drug: placebo vaginal tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous women aged over 18 years of age requesting a copper IUD for contraception, had a negative pregnancy test. Exclusion Criteria: • a prior pregnancy greater than 20 weeks of duration 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 to dinoprostone.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dinoprostone arm<br>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion. | Drug: Dinoprostone 3 mg<br>* 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.<br>|
| Placebo Comparator: placebo<br>one tablet of placebo inserted by the study nurse 6 hours before IUD insertion. | Drug: placebo vaginal tablet<br>* 1 vaginal tablet of placebo inserted by the study nurse 6 hours before IUD insertion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider ease of insertion | Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion. | 5 minutes | 

Secondary 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 at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain | 5 minutes | 
| insertion time | IUD insertion time from speculum in to speculum out | 10 minutes |