Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea

Study Overview
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Brief Summary
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This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,

Detailed Description
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The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins

Official Title
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Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea

Conditions
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to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders Exclusion Criteria: 1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- Allergy to misoprostol

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prostaglandins before iud insertion group<br>this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion | Drug: Misoprostol<br>* misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion<br>|
| placebo group<br>this group will receive placebo tablet before mirena iud insertion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale | By using the visual analogue score | During the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cervical dilataion < 4 mm | need for cervical dilatation to pass the IUD | During the intervention | 
| Pain at insertion according to VAS | By using the visual analogue score | During the intervention | 
| Subjective sensation of satisfaction graduated as VAS like scale | By using the visual analogue score like system | During the intervention | 
| side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting | Bleeding by using the soaked bads | During the intervention | 
| side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia |  | During the first 24 hours | 
| side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion |  | After 30 days of intervention | 
| Duration of insertion(min) | From start of procedure till removing the speculum | During the intervention |