NCT01376947

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 20, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

April 24, 2011

Last Update Submit

June 17, 2011

Conditions

Complication of Device Insertion

Keywords

IUD device insertionNulliparousMultiparousPain

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women that desire to use IUD as anticonceptional method

You may qualify if:

  • Healthy WOmen

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNICAMP - Departamento de Tocoginecologia

Campinas, São Paulo, 13083-887, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Raquel Gouvea Santos, MD

    UNICAMP - master degree student

    PRINCIPAL INVESTIGATOR

  • Ilza Urbano, PHD

    Professor at UNICAMP

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2011

First Posted

June 20, 2011

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

June 20, 2011

Record last verified: 2011-06

Locations

BR(1)