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

Complication of Device Insertion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01376947
• Other study ID #: 02/2011/PC
• Status: Active, not recruiting
• Phase: N/A
• First received: April 24, 2011
• Last updated: June 17, 2011
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2011
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy WOmen

Exclusion Criteria:

• Pregnancy

• Use of pain medication previous to the insertion

• Prior use of IUDs

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complication of Device Insertion

Locations

Country	Name	City	State
Brazil	UNICAMP - Departamento de Tocoginecologia	Campinas	SAo Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Center for Research on Reproductive Health of Campinas

Country where clinical trial is conducted

Brazil,