Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

NCT ID: NCT04339348

Last Updated: 2021-05-07

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

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-03-01

Brief Summary

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the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries

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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vaginal misoprostol

vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus vaginal inert placebo cream at the time of IUD insertion

Group Type EXPERIMENTAL

vaginal misoprostol

Intervention Type DRUG

vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion

lidocaine prilocaine cream

Lidocaine-prilocaine anesthetic cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo will be given 3 hours before LNG-IUD insertion

Group Type ACTIVE_COMPARATOR

Lidocaine-Prilocaine Topical cream

Intervention Type DRUG

Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

placebo

inert vaginal placebo cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours before LNG-IUD insertion

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

Interventions

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vaginal misoprostol

vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion

Intervention Type DRUG

Lidocaine-Prilocaine Topical cream

Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

Intervention Type DRUG

placebo

inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion

Exclusion Criteria

* women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs
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

Principal Investigators

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ahmed taher, MD

Role: STUDY_DIRECTOR

Cairo University

sherif dahab, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

tarek el husseiny

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Ahmedsamy

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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misoprostol vs LP cream

Identifier Type: -

Identifier Source: org_study_id

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