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CompletedNCT02054195PTKPUpdated Feb 4, 2014

Training Model on Insertion Techniques for Postplacental Intra Uterine Device

A Phase 4 interventional study of Training and No Training in Intra-uterine Device Complication, sponsored by Showa University. Completed at 1 site in Indonesia. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-04.

Sponsored by Showa University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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 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

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Conditions studied

  • Intra-uterine Device Complication
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In context

Lead sponsor

Showa University is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly

Exclusion criteria

Exclusion Criteria:

  • Any bleeding and infection complication
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    IUD new technique

    Training

    Behavioral: Training

  • Experimental
    No Training

    No Training

    Behavioral: No Training

Interventions

  • BehavioralTraining

    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.

  • BehavioralNo Training

    Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 Months

Secondary outcomes

  1. Percentage of Participants with retained skill and knowledge

    Time frame: 12 Months

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Study locations

1 site
  • Central nationalHospital Cipto Mangunkusumo
    Jakarta, 10430, Indonesia
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02054195
Lead sponsor
Showa University
Responsible party
Yuditiya Purwosunu (MD, Showa University) — Principal investigator
First posted
Feb 4, 2014
Start date
Aug 2012
Primary completion
Sep 2013
Completion
Oct 2013
Last update
Feb 4, 2014

Study contacts

Seno Adjie, MD, PhD
principal investigator · Indonesia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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