Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

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

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-05-31

Brief Summary

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Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

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Detailed Description

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Conditions

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Contraception

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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lidocaine group

lidocaine in-situ gel inserted vaginally

Group Type EXPERIMENTAL

lidocaine gel

Intervention Type DRUG

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

placebo group

placebo gel inserted vaginally

Group Type PLACEBO_COMPARATOR

placebo gel

Intervention Type DRUG

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Interventions

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lidocaine gel

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Intervention Type DRUG

placebo gel

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-pregnant women
* Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion
* Women who delivered only by caesarean section

Exclusion Criteria

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to lidocaine.
* Women refuse to participate in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No