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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04646161
• Other study ID #: professor
• Status: Recruiting
• Start date: November 25, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: hany saad, assisstant prof
• Phone: 01001817211
• Email: hanysaad25280[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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,

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Misoprostol
misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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