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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by University of Campinas, Brazil.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376947
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Center for Research on Reproductive Health of Campinas
Information provided by:
University of Campinas, Brazil
  Purpose

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.


Condition
Complication of Device Insertion

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous and Evaluation of Cause of Failure of Insertion

Further study details as provided by University of Campinas, Brazil:

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women that desire to use IUD as anticonceptional method
Criteria

Inclusion Criteria:

  • Healthy WOmen

Exclusion Criteria:

  • Pregnancy
  • Use of pain medication previous to the insertion
  • Prior use of IUDs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376947


Locations
Brazil
UNICAMP - Departamento de Tocoginecologia
Campinas, SAo Paulo, Brazil, 13083-887
Sponsors and Collaborators
University of Campinas, Brazil
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
  More Information

Responsible Party: Ana Raquel Gouvea Santos, MAster degree student
ClinicalTrials.gov Identifier: NCT01376947     History of Changes
Other Study ID Numbers: 02/2011/PC
First Submitted: April 24, 2011
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by University of Campinas, Brazil:
IUD device insertion
Nulliparous
Multiparous
Pain