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Training Model on Insertion Techniques for Postplacental Intra Uterine Device (PTKP)

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ClinicalTrials.gov Identifier: NCT02054195
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Yuditiya Purwosunu, Showa University

Brief 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

Condition or disease Intervention/treatment Phase
Intra-uterine Device Complication Behavioral: Training Behavioral: No Training Phase 4

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion
Study Start Date : August 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: IUD new technique
Training
Behavioral: Training
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.

Experimental: No Training
No Training
Behavioral: No Training
Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of Participants with retained skill and knowledge [ Time Frame: 12 Months ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any bleeding and infection complication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054195


Locations
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Indonesia
Central nationalHospital Cipto Mangunkusumo
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Showa University
Investigators
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Principal Investigator: Seno Adjie, MD, PhD Indonesia University

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Responsible Party: Yuditiya Purwosunu, MD, Showa University
ClinicalTrials.gov Identifier: NCT02054195    
Other Study ID Numbers: jm1
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014