Training Model on Insertion Techniques for Postplacental Intra Uterine Device

Intra-uterine Device Complication Clinical Trial

— PTKP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054195
• Other study ID #: jm1
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2014
• Last updated: February 1, 2014
• Start date: August 2012
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Showa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Any bleeding and infection complication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intra-uterine Device Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Central nationalHospital Cipto Mangunkusumo	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Showa University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Months	Yes
Secondary	Percentage of Participants with retained skill and knowledge		12 Months	No