Misoprostol Prior to Intrauterine Device Insertion

NCT04932382 | Completed

• 1 other identifier: MISO-IUD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

IUD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The ease of IUD insertion: will be measured by visual analogue like scale [from 0 to 10]

  5 minutes

Study Arms (2)

Misoprostol group

OTHER

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

Drug: Misoprostol; Device: IUD

No misoprostol group

OTHER

will not receive any pre-insertion medications.

Device: IUD

Interventions

Misoprostol DRUG

will be used 3 h before IUD insertion

Misoprostol group

IUD DEVICE

a copper T380A IUD

Misoprostol group; No misoprostol group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 21, 2021
• Study Start: October 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

EG (1)