Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion

Phase 4

Completed

• Conditions: IUD Insertion
• Interventions: Drug: glyceryl trinitrate cream; Drug: lidocaine cream; Drug: placebo cream

• Registration Number: NCT02708251
• Lead Sponsor: Assiut University

Brief Summary

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive method that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-15
• Study Start: 2016-10
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glyceryl trinitrate cream	glyceryl trinitrate cream	The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL glyceryl trinitrate cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.
lidocaine cream	lidocaine cream	The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL lidocaine creamwill be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.
placebo cream	placebo cream	The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine.1 mL placebo cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.

Primary Outcome Measures

Name	Time	Method
Mean pain score during IUD insertion	3 minutes

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction score after the procedure	3 minutes

Trial Locations

Locations (1)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt