Overview

This trial is active, not recruiting.

Condition complication of device insertion
Sponsor University of Campinas, Brazil
Collaborator Center for Research on Reproductive Health of Campinas
Start date November 2010
End date June 2011
Trial size 100 participants
Trial identifier NCT01376947, 02/2011/PC

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Nulliparous women who were submitted to IUD device insertion
Multiparous women with no cesarean sections that were submitted to IUD device insertion
multiparous women with a cesarean section that were submitted to IUD insertion

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - Healthy WOmen Exclusion Criteria: - Pregnancy - Use of pain medication previous to the insertion - Prior use of IUDs

Additional Information

Official title Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous and Evaluation of Cause of Failure of Insertion
Principal investigator Ana Raquel Gouvea Santos, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by University of Campinas, Brazil.