Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women

IUCD Complication Clinical Trial

Official title:

Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Overweight and Obese Women :a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04505917
• Other study ID #: aswu/352/4/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: hany f Sallam, md
• Phone: +20102435461
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese women

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• multi parous women requesting copper IUD insertion

• body mass index more than 25

Exclusion Criteria:

• pregnancy,

• null parous women,

• contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,

• untreated active cervicitis or vaginitis,

• undiagnosed abnormal uterine bleeding

Related Conditions & MeSH terms

• IUCD Complication

Intervention

Drug:
• dinoprostol
2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
• misoprostol
2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
• placebo
2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in visual analog scale pain scores during intrauterine device insertion	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10	10 minuts
Secondary	Intensity of pain: visual analogue scale	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10	30 minutes after the procedure
Secondary	the difference in visual analog scale pain scores during tenaculum application	The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10	10 minutes
Secondary	the ease of IUD insertion	the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)	10 minutes
Secondary	women's satisfaction level: score	women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction	10 minutes