Misoprostol Prior to Intrauterine Device Insertion

Not Applicable

Completed

• Conditions: IUD
• Interventions: Device: IUD; Drug: Misoprostol

• Registration Number: NCT04932382
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-12
• Study First Submitted QC: 2021-06-12
• Study First Posted: 2021-06-21
• Study Start: 2021-10-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No misoprostol group	IUD	will not receive any pre-insertion medications.
Misoprostol group	IUD	400 µg misoprostol vaginally ; these tablets will be introduced by the principal investigator, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position
Misoprostol group	Misoprostol	400 µg misoprostol vaginally ; these tablets will be introduced by the principal investigator, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position

Primary Outcome Measures

Name	Time	Method
The degree of pain perception during IUD insertion assessed by visual analogue scale	5 minutes	The visual analogue scale scored from 0 to 10 degree, 0 degree means no pain while 10 degree means maximum pain

Secondary Outcome Measures

Name	Time	Method
The ease of IUD insertion: will be measured by visual analogue like scale [from 0 to 10]	5 minutes	0 means very easy insertion and 10 means so difficult insertion

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt