Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion

NCT ID: NCT04340778

Last Updated: 2020-04-10

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-09-05

Brief Summary

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the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial

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 dinoprostone

vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion.

Group Type EXPERIMENTAL

vaginal dinoprostone

Intervention Type DRUG

vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion

lidocaine prilocaine cream

Lidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion

Group Type ACTIVE_COMPARATOR

Lidocaine-prilocaine Cream

Intervention Type DRUG

Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion

placebo

inert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion

Interventions

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vaginal dinoprostone

vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion

Intervention Type DRUG

Lidocaine-prilocaine Cream

Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion

Intervention Type DRUG

placebo

inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* nulliparous women requesting copper IUD insertion

Exclusion Criteria

* multiparous women, active vaginal or cervical infections and contraindications to 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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dinoprostone vs LP cream

Identifier Type: -

Identifier Source: org_study_id

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