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

• Conditions: to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins
• Interventions: Drug: Misoprostol

• Registration Number: NCT04646161
• Lead Sponsor: Cairo University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-11-07
• Study First Submitted QC: 2020-11-20
• Study Start: 2020-11-25
• Study First Posted: 2020-11-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prostaglandins before iud insertion group	Misoprostol	this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion

Primary Outcome Measures

Name	Time	Method
Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale	During the intervention	By using the visual analogue score

Secondary Outcome Measures

Name	Time	Method
cervical dilataion < 4 mm	During the intervention	need for cervical dilatation to pass the IUD
Pain at insertion according to VAS	During the intervention	By using the visual analogue score
Subjective sensation of satisfaction graduated as VAS like scale	During the intervention	By using the visual analogue score like system
side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting	During the intervention	Bleeding by using the soaked bads
Duration of insertion(min)	During the intervention	From start of procedure till removing the speculum
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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt