Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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IUD Insertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

glyceryl trinitrate cream

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

lidocaine cream

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

placebo cream

Intervention Type DRUG

Interventions

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glyceryl trinitrate cream

Intervention Type DRUG

lidocaine cream

Intervention Type DRUG

placebo cream

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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