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Indomethacin Use in Pain Relief During Intrauterine Device Insertion

NCT ID: NCT02711358

Last Updated: 2016-11-29

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

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.

Detailed Description

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Conditions

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Family Planning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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indomethacin

indomethacin suppositories

Group Type EXPERIMENTAL

indomethacin suppositories

Intervention Type DRUG

The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure

placebo

placebo suppositories

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure

Interventions

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indomethacin suppositories

The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure

Intervention Type DRUG

placebo

The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to intrauterine device insertion
* Women who will accept to participate in the study

Exclusion Criteria

* Any contraindication to intrauterine device placement
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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INDO

Identifier Type: -

Identifier Source: org_study_id