Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

Study Overview
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Brief Summary
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To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young 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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Benefits of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial

Conditions
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IUCD Complication

Intervention / Treatment
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* Drug: INH
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device Exclusion Criteria: pregnancy and contraindication or allergy to or contraindication to IUD insertion, chronic pelvic pain, pelvic inflammatory disease, analgesic intake 24 hours prior to IUD insertion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 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 study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INH<br>3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion. | Drug: INH<br>* 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.<br>|
| Placebo Comparator: Placebo Comparator<br>3 tablet of placebo self-administered by the patient 12 hours before IUD insertion | Drug: Placebo Comparator<br>* 3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of IUD insertion | duration of IUD insertion measured in minutes | 10 minutes | 
| 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. | 10 minutes |