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OpenTrials
Completed

NCT Number: NCT04932382

Misoprostol Prior to Intrauterine Device Insertion

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.

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Key information

Conditions

IUD

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol

Drug

will be used 3 h before IUD insertion

IUD

Device

a copper T380A IUD

Primary outcomes

  1. The degree of pain perception during IUD insertion assessed by visual analogue scale

    Time frame: 5 minutes

    The visual analogue scale scored from 0 to 10 degree, 0 degree means no pain while 10 degree means maximum pain

Secondary outcomes

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

    Time frame: 5 minutes

    0 means very easy insertion and 10 means so difficult insertion

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Misoprostol Prior to Intrauterine Device Insertion in Non-menstruating Women

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2021
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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