Intra-uterine Device ComplicationPhase 4PTKPNCT02054195
Training Model on Insertion Techniques for Postplacental Intra Uterine Device
A Phase 4 study testing Training and No Training in people with Intra-uterine Device Complication, run by Showa University at 1 site in Indonesia.
Trial summary
This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intra-uterine Device Complication
- What is being tested?
- Training and No Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2012to Oct 2013
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly
Who cannot join
- Any bleeding and infection complication
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Central nationalHospital Cipto Mangunkusumo
Jakarta, Jakarta Special Capital Region, 10430
About this study
Official title: Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion
This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion
Read the detailed description
The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion
- Conditions
- Intra-uterine Device Complication
- Being tested
- Training, No Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Training model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion.
No TrainingBehavioural
Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.
| Study group | Role | What they receive |
|---|---|---|
| IUD new technique | Experimental | Training Receives: Behavioral: Training |
| No Training | Experimental | No Training Receives: Behavioral: No Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with IUD total or partial expulsion
Transabdominal ultrasonography examination was done by researcher right after insertion. Ultrasonography examination was done using longitudinal and transversal scan, with client in supine position using real time convex 2 probe with 3,5 Mhz frequency. While transvaginal ultrasonography examination was done when the client come after 6 weeks, 6 months and 12 months after insertion.
Measured: 12 Months
Secondary outcomes (1)
Percentage of Participants with retained skill and knowledge
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-uterine Device ComplicationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuditiya Purwosunu, Showa University
- Investigators
- Seno Adjie, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054195
- Sponsor's protocol ID
- jm1
- Acronym
- PTKP
- Status last verified
- Feb 2014
- First submitted
- 25 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion
- ClinicalTrials.gov ID
- NCT02054195
- Acronym / sponsor ID
- PTKP / jm1
- Conditions
- Intra-uterine Device Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Showa UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Feb 2014 (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.
This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion
Detailed description
The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUD new technique | Experimental | Behavioral: TrainingTraining |
| No Training | Experimental | Behavioral: No TrainingNo Training |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly
Key exclusion criteria (1 listed)
- Any bleeding and infection complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingTraining model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion. | Behavioural | IUD new technique |
| No TrainingControl of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus. | Behavioural | No Training |
Primary outcome
Number of Participants with IUD total or partial expulsion
Time frame: 12 Months
Transabdominal ultrasonography examination was done by researcher right after insertion. Ultrasonography examination was done using longitudinal and transversal scan, with client in supine position using real time convex 2 probe with 3,5 Mhz frequency. While transvaginal ultrasonography examination was done when the client come after 6 weeks, 6 months and 12 months after insertion.
1 secondary outcome
Percentage of Participants with retained skill and knowledge
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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.
Seno Adjie, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Training and No Training in people with Intra-uterine Device Complication, run by Showa University at 1 site in Indonesia.
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 1 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: finished, as of the sponsor's last update on 4 Feb 2014. 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 Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Number of Participants with IUD total or partial expulsion (time frame: 12 Months). It is what the study was designed to measure, not a finding.
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 4 Feb 2014.