Complication of Device InsertionNCT01376947
Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous Women
An observational study of Complication of Device Insertion, run by University of Campinas, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complication of Device Insertion
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women that desire to use IUD as anticonceptional method
Who may be able to join
- Healthy WOmen
Who cannot join
- Pregnancy
- Use of pain medication previous to the insertion
- Prior use of IUDs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
UNICAMP - Departamento de Tocoginecologia
Campinas, São Paulo, 13083-887
About this study
Official title: 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.
Read the 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.
- Conditions
- Complication of Device Insertion
- Keywords
- IUD device insertion, Nulliparous, Multiparous, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Device InsertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research on Reproductive Health of Campinas
- Investigators
- Ana Raquel Gouvea Santos, MD, Principal investigator, UNICAMP - master degree studentIlza Urbano, PHD, Study director, Professor at UNICAMP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376947
- Sponsor's protocol ID
- 02/2011/PC
- Status last verified
- Jun 2011
- First submitted
- 24 Apr 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous and Evaluation of Cause of Failure of Insertion
- ClinicalTrials.gov ID
- NCT01376947
- Acronym / sponsor ID
- 02/2011/PC
- Conditions
- Complication of Device Insertion
- Keywords
- IUD device insertion, Nulliparous, Multiparous, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Center for Research on Reproductive Health of Campinas
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women that desire to use IUD as anticonceptional method
Key inclusion criteria (1 listed)
- Healthy WOmen
Key exclusion criteria (3 listed)
- Pregnancy
- Use of pain medication previous to the insertion
- Prior use of IUDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Raquel Gouvea Santos, MD principal investigator
UNICAMP - master degree student
Ilza Urbano, PHD study director
Professor at UNICAMP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Device Insertion, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2011.