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Completed

NCT Number: NCT04080336

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

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

Completed

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Key information

Conditions

IUD Insertion Complication

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Samy

Giza, 11231, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • nulliparous women requesting copper IUD insertion

Exclusion criteria

  • pregnancy, Parous women, contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, untreated active cervicitis or vaginitis, undiagnosed abnormal uterine bleeding

Treatment and study plan

Dinoprostone

Drug

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3hours before IUD insertion.

Misoprostol

Drug

1 vaginal tablet of misoprostol (200mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Placebo

Drug

one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Primary outcomes

  1. The difference in pain scores during intrauterine device insertion

    Time frame: 10 minutes

    The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Secondary outcomes

  1. the difference in pain scores during tenaculum application

    Time frame: 10 minutes

    The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10

  2. the difference in pain scores during sound insertion

    Time frame: 10 minutes

    The difference in pain scores during sound insertion using a visual analog scale from 0 to 10

  3. the ease of IUD insertion

    Time frame: 10 minutes

    the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)

  4. women's satisfaction level

    Time frame: 10 minutes

    women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women:a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
Jun 30, 2020

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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