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

June 17, 2011 updated by: University of Campinas, Brazil

Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous and Evaluation of Cause of Failure of Insertion

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SAo Paulo
      • Campinas, SAo Paulo, Brazil, 13083-887
        • UNICAMP - Departamento de Tocoginecologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women that desire to use IUD as anticonceptional method

Description

Inclusion Criteria:

  • Healthy WOmen

Exclusion Criteria:

  • Pregnancy
  • Use of pain medication previous to the insertion
  • Prior use of IUDs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Nulliparous
Nulliparous women who were submitted to IUD device insertion
Multiparous with no cesaraen section
Multiparous women with no cesarean sections that were submitted to IUD device insertion
Mulitparous with cesarean section
multiparous women with a cesarean section that were submitted to IUD insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Center for Research on Reproductive Health of Campinas

Investigators

  • Principal Investigator: Ana Raquel Gouvea Santos, MD, UNICAMP - master degree student
  • Study Director: Ilza Urbano, PHD, Professor at UNICAMP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

April 24, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (ESTIMATE)

June 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 17, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02/2011/PC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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