Misoprostol Prior to Intrauterine Device Insertion

IUD Clinical Trial

Official title:

Misoprostol Prior to Intrauterine Device Insertion in Non-menstruating Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932382
• Other study ID #: MISO-IUD
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive method . In spite of that, the pain associated with IUD insertion can be a cause against its insertion. Many researches have been conducted aiming to decrease the degree of pain during IUD insertion; these studies included medical and also technical methods. The physicians usually prefer to insert the IUD during women's menses because the women are very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness of IUD insertion is a very important issue that can increase women's satisfaction and decrease insertion pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women aged 18-45 years
• Non-pregnant women
• Women who will come when there are non-menstruating.

Exclusion Criteria:

• Women received any analgesics or misoprostol in the 24 hours prior to insertion
• Women with any contraindications for IUD insertion
• Nulliparous women
• Women refuse to participate.
• Women have any contraindication of misoprostol.

Related Conditions & MeSH terms

• IUD

Intervention

Drug:
• Misoprostol
will be used 3 h before IUD insertion

Device:
• IUD
a copper T380A IUD

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of pain perception during IUD insertion assessed by visual analogue scale	The visual analogue scale scored from 0 to 10 degree, 0 degree means no pain while 10 degree means maximum pain	5 minutes
Secondary	The ease of IUD insertion: will be measured by visual analogue like scale [from 0 to 10]	0 means very easy insertion and 10 means so difficult insertion	5 minutes