Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion

NCT ID: NCT04339361

Last Updated: 2020-04-09

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-25

Study Completion Date

2020-08-15

Brief Summary

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the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in 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 (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion

Group Type EXPERIMENTAL

lidocaine spray

Intervention Type DRUG

four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

vaginal dinoprostone

vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement

Group Type ACTIVE_COMPARATOR

vaginal dinoprostone

Intervention Type DRUG

vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

placebo

vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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lidocaine spray

four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

Intervention Type DRUG

vaginal dinoprostone

vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Intervention Type DRUG

placebo

vaginal placebo will be 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

* nulliparous women requesting levonorgestrel IUD insertion

Exclusion Criteria

* multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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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

Central Contacts

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AHMED SAMY

Role: CONTACT

+201100681167

Other Identifiers

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lidocaine spray IUD

Identifier Type: -

Identifier Source: org_study_id

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