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Efficacy of Ketoprofen Before Intrauterine Device Insertion

NCT ID: NCT02905058

Last Updated: 2017-11-14

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

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IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

Detailed Description

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To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.

Conditions

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Pain Relief

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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Ketoprofen

women will take one tablet 150 mg one hour before the procedure

Group Type EXPERIMENTAL

Ketoprofen

Intervention Type DRUG

oral non-steroidal antiinflammatory drug

Placebo

women will take one placebo tablet one hour before the procedure

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Ketoprofen

oral non-steroidal antiinflammatory drug

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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bi profenid

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 insertion
* No contraindication to Non-steroidal drugs
* Women who will accept to participate in the study

Exclusion Criteria

* Any contraindication to device placement
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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KETOIUD

Identifier Type: -

Identifier Source: org_study_id