Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion

Study Overview
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Brief Summary
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To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.

Detailed Description
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Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.

Official Title
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Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical 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: Non-pregnant women Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion Women who delivered only by cesarean section Exclusion Criteria: Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids. Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use Allergy to isonicotinic acid hydrazide . Women refuse to participate in the study

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 trial
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 12 hours before IUD insertion.<br>* Other names: isonicotinic acid hydrazide;|
| Placebo Comparator: Placebo Comparator<br>3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion. | Drug: Placebo Comparator<br>* 3 vaginal tablet of Placebo Comparator self inserted 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 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 | 10 minutes | 

Secondary 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. | 10 minutes | 
| insertion time | IUD insertion time from speculum in to speculum out | 10 minutes |