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Completed

NCT Number: NCT02054195

Training Model on Insertion Techniques for Postplacental Intra Uterine Device

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

Completed

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Key information

Conditions

Intra-uterine Device Complication

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Central nationalHospital Cipto Mangunkusumo

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any bleeding and infection complication

Treatment and study plan

Training

Behavioral

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 Training

Behavioral

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

Primary outcomes

  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 outcomes

  1. Percentage of Participants with retained skill and knowledge

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Showa University

Other

Registry information

Official study title

Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion

Acronym: PTKP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2014
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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