Dinoprostone vs Misoprostol Before LNG-IUD Insertion

NCT ID: NCT04301349

Last Updated: 2020-03-10

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2020-06-30

Brief Summary

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the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Detailed Description

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Conditions

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IUD Insertion Pain

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 6 mg (two tablets) 3 hours prior to IUD insertion

Group Type EXPERIMENTAL

vaginal dinoprostone

Intervention Type DRUG

two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion

vaginal misoprostol

vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion

Group Type ACTIVE_COMPARATOR

vaginal misoprostol

Intervention Type DRUG

two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion

placebo

two tablets of placebo similar in shape ,color, odor to the study drugs

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

two tablets of placebo given 3 hours prior to IUD insertion

Interventions

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vaginal dinoprostone

two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion

Intervention Type DRUG

vaginal misoprostol

two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion

Intervention Type DRUG

placebo

two tablets of placebo given 3 hours prior to IUD insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* multiparous women requesting IUD insetion

Exclusion Criteria

* active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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 SAMY

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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AHMED SAMY, MD

Role: CONTACT

+201100681167

Other Identifiers

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dinoprostone IUDs

Identifier Type: -

Identifier Source: org_study_id

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