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OpenTrials
Completed

NCT Number: NCT04339049

Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women

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Key information

Conditions

Contraception

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Ashour

Giza, 12944, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adolescent and young nulliparous women requesting IUD insertion

Exclusion criteria

  • multiparous women, contraindications to IUD insertion or to study drugs

Treatment and study plan

Lidocaine spray

Drug

four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

Vaginal Misoprostol

Drug

vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Placebo

Drug

vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Primary outcomes

  1. pain during IUD insertion

    Time frame: 5 minutes

    pain during IUD insertion evaluated by visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable

Secondary outcomes

  1. duration of IUD insertion

    Time frame: 5 minutes

    duration of IUD insertion from speculum in to speculum out

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Algazeerah hospital

Registry information

Official study title

Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in Reducing Pain During IUD Insertion in Adolescents and Nulliparous Women: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2020
Registry last updated
Dec 10, 2021

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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