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Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

NCT ID: NCT04339049

Last Updated: 2021-12-10

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

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-07-30

Brief Summary

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the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lidocaine spray

four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

Group Type EXPERIMENTAL

lidocaine spray

Intervention Type DRUG

four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

vaginal misoprostol

vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Group Type ACTIVE_COMPARATOR

vaginal misoprostol

Intervention Type DRUG

vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

placebo

vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Interventions

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lidocaine spray

four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

Intervention Type DRUG

vaginal misoprostol

vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Intervention Type DRUG

placebo

vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adolescent and young nulliparous women requesting IUD insertion

Exclusion Criteria

* multiparous women, contraindications to IUD insertion or to study drugs
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Algazeerah hospital

UNKNOWN

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

assistant professor obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Ashour

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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lidocaine IUD

Identifier Type: -

Identifier Source: org_study_id