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Training Model on Insertion Techniques for Postplacental Intra Uterine Device

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02054195
Acronym
PTKP
Enrollment
230
Registered
2014-02-04
Start date
2012-08-31
Completion date
2013-10-31
Last updated
2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-uterine Device Complication

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

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

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.

Sponsors

Showa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Any bleeding and infection complication

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with IUD total or partial expulsion12 MonthsTransabdominal 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

MeasureTime frame
Percentage of Participants with retained skill and knowledge12 Months

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026