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Completed

NCT Number: NCT04339348

Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries

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Key information

Conditions

Contraception

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmedsamy

Giza, 12511, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion

Exclusion criteria

  • women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs

Treatment and study plan

Vaginal Misoprostol

Drug

vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion

Lidocaine-Prilocaine Topical cream

Drug

Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

Placebo

Drug

inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

Primary outcomes

  1. pain during LNG-IUD insertion

    Time frame: 5 minutes

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

Secondary outcomes

  1. duration of insertion

    Time frame: 5 minutes

    duration of LNG-IUD insertion from speculum in to speculum out

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Reducing Pain During Levonorgestrel IUD Insertion in Women Delivered Only by Cesarean Deliveries

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2020
Registry last updated
May 7, 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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