Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous Women

NCT ID: NCT01376947

Last Updated: 2011-06-20

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-10-31

Brief Summary

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In this study the investigators compare the difficulty at insertion of IUD between nulliparous and parous women. The investigators compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion.

The investigators hypothesis is that there is no difference between nulliparous and multiparous patients.

Detailed Description

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In our study we compare the difficulty at insertion of IUD between nulliparous and parous women with an without cesarean section.

We compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion. We also compare the pain the patient refers on the day of insertion and the pain the patient refers to remember a month after insertion.

Our hypothesis is that there is no difference between nulliparous and multiparous patients.

Conditions

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Complication of Device Insertion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Nulliparous

Nulliparous women who were submitted to IUD device insertion

No interventions assigned to this group

Multiparous with no cesaraen section

Multiparous women with no cesarean sections that were submitted to IUD device insertion

No interventions assigned to this group

Mulitparous with cesarean section

multiparous women with a cesarean section that were submitted to IUD insertion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy WOmen

Exclusion Criteria

* Pregnancy
* Use of pain medication previous to the insertion
* Prior use of IUDs
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Research on Reproductive Health of Campinas

OTHER

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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MAster degree student

Principal Investigators

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Ana Raquel Gouvea Santos, MD

Role: PRINCIPAL_INVESTIGATOR

UNICAMP - master degree student

Ilza Urbano, PHD

Role: STUDY_DIRECTOR

Professor at UNICAMP

Locations

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UNICAMP - Departamento de Tocoginecologia

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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02/2011/PC

Identifier Type: -

Identifier Source: org_study_id

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