Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion

NCT02708251 | Completed Phase 4 DMC

• 1 other identifier: GTN
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

IUD Insertion

Outcome Measures

Primary Outcomes (1)

• Mean pain score during IUD insertion

  3 minutes

Secondary Outcomes (1)

• Patient satisfaction score after the procedure

  3 minutes

Study Arms (3)

glyceryl trinitrate cream

EXPERIMENTAL

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.

Drug: glyceryl trinitrate cream

lidocaine cream

EXPERIMENTAL

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.

Drug: lidocaine cream

placebo cream

PLACEBO COMPARATOR

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.

Drug: placebo cream

Interventions

glyceryl trinitrate cream DRUG

glyceryl trinitrate cream

lidocaine cream DRUG

lidocaine cream

placebo cream DRUG

placebo cream

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women not taken analgesics or anxiolytics in the 24 hours prior insertion
• Women not taken misoprostol prior to IUD insertion
• No contraindication to or history of allergic reaction to lidocaine or NO donors.
• Women who will accept to participate in the study

You may not qualify if:

• Lidocaine allergy
• History of migraine or chronic headache
• Any contraindication to IUD placement

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Related Publications (1)

• Abbas AM, Ragab E, Abd Ellah NH, Sabra A, Ali SS, Mohamed A, Yosef AH. Effect of topical glyceryl trinitrate cream on pain perception during intrauterine device insertion in multiparous women: A randomized double-blinded placebo-controlled study. J Gynecol Obstet Hum Reprod. 2019 Nov;48(9):715-718. doi: 10.1016/j.jogoh.2019.03.007. Epub 2019 Mar 18.

  PMID: 30898632 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 15, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)